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The role of standards in decontamination
The role of standards in decontamination
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R. Bancroft STERIS Corporation, Leicester, United Kingdom
17.1 Introduction A standard is a technical document, drafted by recognized standards bodies, that seeks to establish standardized specifications, requirements and practices. They are used in decontamination to help ensure that medical devices, materials, and processes are fit for purpose, i.e., safe, reliable, and of appropriate quality. In an increasingly regulated environment, decontamination makes extensive use of these documents to allow practitioners and manufacturers to follow and hence claim conformity to these established criteria for the purposes of minimizing errors across geographic or technical areas, and helping to ensure alignment and common understanding. Standards help to eliminate trade barriers to allow free and fair trade and form a common “language” between users of such documents. All of these standards, with the exception of private standards, are publicly available documents, usually for a fee. They have been written on the premise of consensus by multidisciplinary groups of people, and have been developed in a formal and structured way. This development structure allows for open consultation at prescribed stages and culminates in a formal approval of the document prior to publication. Standards play a key role in practice for medical device decontamination in the healthcare and medical device industrial areas and act as a route to compliance with legal requirements. In Germany, a standard is known as a norm, whereas in France, a standard is known as a norme.
17.2 Relationship of standards to law and guidance Standards are generally written as voluntary requirements, and hence are not intended directly to be mandatory. However, standards are often used as a route to compliance to requirements that may be mandatory and as such, standards have a very important role. The regulatory structure and requirements in different parts of the world clearly differ, but at a top-level perspective, there is much commonality. Every country has its own national laws, which of course vary from country to country. Within Europe, there is much commonality, with EU legislation being implemented either directly by way of a European Regulation, or into EU member state’s law through European Directives. European Directives are legislative acts of the European Union and are used to achieve a particular result without dictating the means Decontamination in Hospitals and Healthcare. https://doi.org/10.1016/B978-0-08-102565-9.00017-0 © 2020 Elsevier Ltd. All rights reserved.
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of achieving that result, and allow EU member states a certain element of leeway as to exactly how it is adopted into national law. European Regulations, however, are self-executing and do not require any implementing measures, and become immediately enforceable as law in all EU member states. EU Regulations and Directives are written by EU commissioners and are legal instruments within Europe, and form the basis for much European law, and are required to be implemented into each of the 28 EU member states. Much has changed in the case of the medical device legislation in the EU; the EU Medical Devices Directive 93/42/EEC, modified by the 2007/47/EC amending directive, is being replaced by Regulation (EU) 2017/745, with an implementation date of 26th May 2020. This new regulation combines the General Medical Device Directive, 93/42/EEC, with the Active Implantable Medical Device Directive, 90/385/EEC. As a consequence of these changes, many current standards are being harmonized against the new regulation, and many current standards will be updated as a consequence. These regulations place obligations on manufacturers and other economic operators (legal entities responsible for bringing a product to the market) to ensure that devices are safe and fit for their intended purpose, and are worded in a particular legal style. The salient part of these new regulations are the general safety and performance requirements (GSPRs—formerly known as Essential Requirements—ERs—in the Medical Devices Directive) that form the basis of a minimum standard for safety, allowing for free (without hindrance) interstate commerce within the EU, i.e., without trade barriers. Compliance with the ERs or GSPRs of this (and other applicable EU Regulations or Directives) allows for affixing of the CE mark. As the CE mark confers conformity with the General Safety and Performance Requirements or Essential Requirements of applicable regulations or directives respectively, the CE mark means that a device meets the minimum safety requirements and hence can be sold throughout Europe, theoretically without any further barrier to trade. As these form the basis for EU law, the text is often written at a high level and is nonspecific; however European Regulations such as the Medical Devices Regulation are much more specific and detailed than their predecessors. Within the United States, the decontamination of medical devices within hospitals is not directly controlled by the US Food and Drug Administration (FDA); however manufacturers of such devices are subject to control by FDA and Title 21 of the Code of Federal Regulations (21 CFR). Section 18 in Chapter 1 of 21 CFR covers the requirements for medical devices. In Australia, medical devices have their legal basis in the Therapeutic Goods Act. The legal requirements and their implementation in these geographical areas are clearly different; however each statutory law must be practically enacted; these legal documents tend to be quite general in their verbiage, and so a more specific interpretation of these legal requirements is often sought. Standards are often used in this way; however there does need to be a link between the statutory law and the standard; in Australia, this mechanism is by a Medical Device Standards Order (MDSO). In the United States, medical device manufacturers may choose to use the FDA Recognized Consensus Standard route to obtain a premarket (510(k)) clearance to legally market
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a medical device; hence showing conformity to a recognized consensus standard can greatly expedite premarket clearance. Practitioners and manufacturers within Europe may use the table in Annex Z of one or more harmonized European standards (see European standards below) to show, within the limits of the scope of the harmonized standard, a presumption of conformity with the corresponding Essential Requirements of an applicable European Directive or the General Safety and Performance Requirements of an applicable European Regulation. This means that if this method is used, compliance with the Essential Principles or Conformity Assessment Procedures that the requirements of the standard have been deemed to address is assumed. As we progress down the hierarchy shown in Fig. 17.1, requirements generally become more specific; in the case of guidance documents, these tend to give a recommended course of action to enable compliance with the standards that they support. This more prescriptive approach tends to be more geographically relevant, making use of regional or national custom and practice. Finally, local procedures are the documented method statements applicable to local areas or even facilities that again support the requirements of the standards and ultimately local law (see Chapter 18). It is quite usual that practitioners and manufacturers will largely resort to standards and guidance documents in order to formulate their local procedures, rather than making specific use of the legal requirements, although a basic understanding of the law is generally assumed. These procedures are nonmandatory, but are generally accepted as the best method to demonstrate compliance, ultimately, with the legal requirements.
Fig. 17.1 Schematic of the similar relationship of standards to legal requirements in Australia, Europe and the United States.
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17.3 Key aims and principles of standards Standards are not necessarily mandatory or do not have a direct legal obligation, but they do form the basis of “best practice”—a methodology that, through experience and research, has proven to reliably lead to a desired result. This usually results in a pragmatic direction that allows a clear interpretation of the legal requirements. In order to be accepted as a standard, a number of key principles are expected; first, the standard must be publicly available and published by a recognized body; the development of the standard should consist of a drafting group ideally comprising of expert practitioners, manufacturers, and regulators, and approval of the standard should have been by consultation from all interested parties, hence are often referred to as consensus standards due to their consensus-driven drafting and approval. Increasingly, there are expectations (or in the case of Europe, legal considerations) that standards should not be design restrictive; as long as the outcomes or requirements are stated, how we get there should not be specified. While in principle this is satisfactory, there are practical issues to consider; let us imagine a sterilization scenario where there is a clear and necessary requirement that sterilant penetrates all parts of the load to be sterilized. It would be expected that a standard would specify a specific test method as part of operational qualification (OQ) in order to verify this; however it may be argued that using a standard method is unnecessarily design restrictive, and as long as performance qualification (PQ) justifies sterilant penetration into the load, then this is acceptable. In practice many standards are written where the test methods used to demonstrate a particular attribute are informative (i.e., not normative) parts of the standard in order to prevent the EU rejecting a standard as being design restrictive; however the general feeling is that standards should be written to be as prescriptive as possible.
17.4 Types of standards There are two significant types of standards based on content; these are referred to as standards, consisting typically of what one would expect of a standard by way of requirements, plus technical reports or technical specifications. Standards consist of principally “normative” text, text that is mandatory if compliance to the standard is claimed, and “informative” text, used to explain or justify the normative parts of the document, or parts of the document that are optional or for guidance. When referring to types of standards, however, reference is usually being made to the type of standard with respect to the developer; four types of standard are generally available. These consist of private, national, European, and international standards. Private standards are usually written for a commercial entity or group of entities, and are commissioned for a specific purpose; however as these are, by definition, not publicly available, no further discussion will be made here of this type of standard. Guidance documents may be described as standards; however guidance documents are written in a different style to performance standards; the whole text of guidance is written using terms such as should (rather than the assertive shall that is used in
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normative text), highlighting the optional nature of guidance documents. Guidance documents are, however, more prescriptive in terms of how they describe an action. Typically, the expectation is that guidance documents underpin the normative requirements of a standard (see Section 17.2). International, European, and national standards are discussed in more detail below.
17.5 Vienna agreement In order to prevent duplication of work between CEN and ISO, the agreement on technical cooperation between CEN and ISO of 1991 (Vienna Agreement), revised in 2001, was implemented [1]. The Vienna Agreement recognizes the primacy of international (ISO) standards, and aims to approve in parallel international and European standards. CEN or ISO can take the lead in drafting a new standard and will be presented for simultaneous approval by both standards bodies, and synchronized to achieve the objective of simultaneous publication. The important point is that the standards development is done in either ISO or CEN, and then sent for parallel ballot with member bodies of both CEN and ISO. This clearly means that ISO members can influence content of CEN standards and vice versa, however the Vienna Agreement does specifically allow CEN or ISO to work on the same subject, if deemed necessary. The latest revision (3.3) of the Vienna Agreement gives priority to international standardization, and lends greater importance to ISO leadership than did the previous versions, although there is generally close liaison with CEN members during this process, for example CEN commits to respond adequately to comments from the non-CEN ISO members.
17.6 European standards EN standards are developed by CEN (European Committee for Standardization), based in Brussels, Belgium, and formed in 1975. European standards are also published by CENELEC (European Committee for Electrotechnical Standardization) and ETSI (European Telecommunications Standards Institute); however these standards are not directly used in the area of medical device decontamination (although some CENELEC standards give electrical safety requirements that can be applied to equipment such as sterilizers and washer-disinfectors). CEN standards, like other standards, are voluntary standards, however increasingly support EU policies and legislation. Under European Law, a European standard has to be implemented into each EU state in an unaltered form and any conflicting national standards withdrawn. These standards can afford to be much more prescriptive than Directives or Regulations, and are generally deemed to be considered “best practice.” EU standards can either be “harmonized” or not. The term “harmonized” is often misunderstood; this refers to harmonization within legislation, against a specified directive or directives (as opposed to
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being “harmonized” across all 28 EU member states plus the EFTA states—a requirement of any European standard). Harmonized standards provide a means of conforming to Essential Requirements of specified Regulations or Directives; once the standard has been cited in the Official Journal of the European Union (OJEU), compliance with the certain clauses of the standard provide a presumption of conformity with corresponding Essential Requirements or General Safety and Performance Requirements of specified Directives or Regulations. Harmonized standards are recognized by the presence of one or more annex Zs that include a table which cross references every clause of the Essential Requirements or General Safety and Performance Requirements of the appropriate Directive or Regulation with clauses of the standard. In addition to the presence of these annex Zs, the standard must also be cited in the OJEU. Multiple annex Zs are used to cross reference to other Directives or Regulations; for example, a piece of decontamination equipment may fall under Directives or Regulations for medical devices, machinery, low voltage, electromagnetic emissions, etc. Hence multiple annex Zs may appear in a harmonized standard to enable the standards to be used as a way of demonstrating compliance with the applicable parts of all relevant Directives or Regulations. European standards must be published as national standards within all the EU member states plus the EFTA countries (Iceland, Liechtenstein, Norway, and Switzerland). When these standards are implemented, any national standards that have similar scope must be withdrawn. When EN standards are nationally implemented, they are numbered with the EU member state NSO prefix, so for example in Germany, an EN standard would be prefixed DIN EN followed by the EN number. It is increasingly common that ISO standards are adopted under the Vienna Agreement, hence CEN-adopted ISO documents would be labeled as DIN EN ISO followed by the ISO number in Germany.
17.7 International standards ISO standards are developed by the International Organization for Standardization (ISO). ISO is a network of over 160 national standards organizations (NSOs) with a Central Secretariat in Geneva, Switzerland. ISO is the world’s largest developer of voluntary international standards. International standards give state of the art specifications for products, services, and good practice, helping to make industry more efficient and effective. Developed through global consensus, they help to break down barriers to international trade. The ISO NSOs can adopt standards as national standards; hence in the United Kingdom they would become prefixed as BS ISO followed by the ISO number, or as ANSI/AAMI/ISO in the United States, for example. There is no requirement for an NSO to adopt an ISO standard, and they can in addition be nationally modified, so if France does not like a particular requirement, for example, this could be deleted in the French (NF ISO) national implementation.
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17.8 How standards are drafted The process of standards development follows a prescribed and well-established process. This process is similar for ISO [2, 3], CEN [4], and national standards. Generally, before work can begin on a standard, a New Work Item Proposal (NWIP) is required. This is, in reality, a draft or outline of a standard that is submitted by a National Standards Body (NSB), for example, BSI, to CEN or ISO, and is then balloted by applicable NSBs. Participation in standards development should be by knowledgeable people who represent users, regulators, and manufacturers; participation at EU or ISO level is “representation by country”, i.e., participants should represent views of their nation. Proposals are adopted if two thirds of the votes are in favor, as long as there are not more than one quarter of the votes against. ISO and CEN do differ in their approach to voting; each ISO member country (NSO) has a single vote each, whereas CEN utilizes weighted voting. CEN weighted voting is based on the population size of each country. There are 34 countries that vote on CEN standards; the 28 members of the EU, plus 6 additional countries from within the European Free Trade Association (EFTA) and the EU Single Market countries (Table 17.1). It is expected that the anticipated departure of the United Kingdom from the EU will not change its input into the CEN voting process. Proposals are adopted if 71.00% or more of the weighted votes cast are in favor of the standard (abstentions are not counted). The United Kingdom, being one of the more populous countries in the EU, is one of five countries with the highest weighted vote.
17.8.1 Standards development timescale The established standards development process must allow comments and voting at critical document stages; as such, the process is often viewed as slow and laborious; however it does yield a quality consensus output. Table 17.1 CEN weighted voting by country. Country
Vote weighting per country
Germany, France, the United Kingdom, Italy, Turkey Spain, Poland Romania The Netherlands Belgium, Czech Republic, Greece, Hungary, Portugal Austria, Switzerland, Sweden, Bulgaria Denmark, Finland, Ireland, Lithuania, Norway, Slovakia, Croatia, Serbia Cyprus, Estonia, Latvia, Luxembourg, Slovenia, Republic of North Macedonia Iceland, Malta
29 votes 27 votes 14 votes 13 votes 12 votes 10 votes 7 votes 4 votes 3 votes
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There are a series of formal stages that a document must progress through (Table 17.2). The stages are similar for CEN and ISO documents with one notable exception; the committee stage, commonly known as the CD (committee draft) stage in ISO, does not exist in CEN. The consequence of this is that the document progresses directly from WD (working draft) to prEN stages within CEN, whereas in ISO the document would go through the intermediate CD stage. CEN distributes the enquiry and approval documents in CEN’s 3 official languages—English, French, and German. All document stages allow for national comments to be submitted, with the exception of the approval (final vote) stage, where no comments are normally permitted, and it is simply a yes/no vote, although obvious errors or typographical errors will be corrected. At this stage, it is anticipated that there will be an affirmative vote, based on earlier votes and comments. If the committee or enquiry results indicate (either by comment or by vote) that there is significant dissatisfaction with the document, it is possible to repeat that document stage with a revised document. The timelines specified (Table 17.2) are typical times, as CEN and ISO now promote flexibility in the time taken for individual document stages, in an attempt to expedite document publication. Each stage needs preparatory time before and after each stage in order to ready documents for distribution or to circulate voting results and comments; this preparation time can be in the order of 2 or 3 months. Working group (WG) meetings need to be organized to review results and provide resolutions to comments made on the document. All comments submitted on a document draft must have a response provided by the working group. The working group meetings need to be arranged and agreed by the majority of participants if the meetings are to be productive. Typical standard development timelines from NWIP to approval are expected to be completed within 3 years; development of a standard may be less than this time period if the development is a relatively simple revision of an existing standard; however major revisions can take much longer. ISO recognizes development timelines from 18 to 48 months; failure to meet the agreed timelines can result in a work item being canceled. If there is consensus to continue the work, it will need to be restarted again by approval of an NWIP. Once the standard is implemented, a framework is in place to ensure the standards are continuously reviewed and updated where appropriate. Table 17.2 Standards document stages in CEN and ISO. Document stage
CEN terminology
ISO terminology
Usual stage timeline
Proposal
NWIP
NWIP
Preparatory Committee
WD [None]
WD CD
Enquiry Approval (Final Vote)
prEN FprEN
DIS FDIS
3 months for ballot (but can be shortened to 2 months) Variable 2 months (but can be 3 or 4 months) 3 months 2 months
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All standards are subject to a systematic review at least every 5 years; at this review, three options are available. A standard can be confirmed, meaning that no changes are required, and will next be reviewed in another 5 years; it can be revised, allowing for a new edition to be created, following the process above for standards development. The final option is withdrawal of the standard if it is felt that the standard is no longer useful or current. Amendments may be made to a standard. Amendments are generally issued as a supplementary document, with the intention that they are read in conjunction with the original (current) standard. Amendments can be combined into the original standard, in which case they are referred to in the document number, for example EN XXX:2006 + A2:2009, here noting a second amendment in 2009, amending a document published in 2006. Amendments will go through the usual formal document approval procedure outlined above. Publishing errors are termed corrigenda and are used to correct printing, linguistic, and editorial errors. The existence of a corrigendum should be made known to all users of a standard, hence highlighting the need to verify the current status of a standard via CEN or ISO websites (see “Sources of further information and advice” section). Corrigenda are not usually subject to formal approval procedures and hence can be issued relatively quickly.
17.8.2 Providing comments, corrections, and improvements to standards The speed and efficiency of working group meetings can be greatly enhanced by the quality of comments provided on a document; ISO and CEN use identical comment template documents. These comments must be submitted to CEN or ISO via the respective NSO; for example, comments from the United Kingdom would be submitted to BSI, who would collate and agree them, prior to submitting to CEN or ISO. Comments provided on documents must be clear and concise, correctly reference the clause or clauses that are being addressed, and (most importantly) provide alternative (suggested) text. If a comment is provided that states “this section is unclear; please reword,” it is unlikely that the working group will spend much time deliberating the comment.
17.9 How to read and understand a standard Standards are written using very deliberate language; they are not meant to be works of literary brilliance; so it is not uncommon to see, for example, repetitive text or strange sentence construction that is used to ensure that there is no ambiguity in the requirements given. The language used in a standard depends upon the nature of the section; standards use the term “shall” in order to show mandatory or normative requirements, for example, or “should” to show guidance or optional informative text. If a product or service claims conformity to a standard, it must comply with every requirement in that
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standard, i.e., a claim to conformity is an absolute. Partial c onformity is generally not appropriate. The sections of a standard are normally prepared in a consistent format and usually contain the following sections: Title
The title of a standard is simply to identify the standard to interested parties, so needs to capture simply and explicitly the nature of the standard. Foreword
The foreword is used to describe who was involved (by committee title) in drafting the standard, and any interrelationship with other parts (if one of a series) of standards, or other parts. Introduction
This introduces the context of the standard, but has little formal relevance to the requirements of the standard. Scope
The scope is one of the most important sections of a standard, and is arguably more important than the title; the scope details the inclusions (and sometimes the exclusions) of the standard, what is actually specified and to whom the standard is aimed at (manufacturer, practitioner, etc.). Normative references
The normative references are simply a list of (usually) other standards that are cited in a normative way within the standard, i.e., compliance with this standard is not possible without compliance with some or all of the requirements of other standards that are cited in the normative references. Care must be taken in this area, however, as there can be a chain of normative requirements if the normatively referred standard does itself have normative requirements; this chain can invoke many additional requirements over several standards. Notes
Notes can be used throughout the standard. They are easy to identify as they are preceded by the word “note.” Notes are used to clarify meaning of the text, and cannot modify the requirements specified. As such, they are considered to be informative rather than normative parts of the standard. Terms and definitions
Definitions in a standard are not meant to serve as a dictionary or encyclopedia to a casual reader; they are often used as scientific terms with a very specific meaning. Definitions are only relevant to the standard to which they relate, and simplify and abbreviate the standard by allowing a simple term or definition to have a sometimes long and complicated meaning. There are always attempts to ensure that the same terms used in a series or area of standardization have the same definition, in order to minimize any possible confusion. For example, the term “fault” may have a very particular
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definition within a given standard, and this meaning may not be necessarily the same as a lay persons’ understanding, or a dictionary definition, of the same term, although there is always an attempt to align definitions within a given subject area, so that, for example, health care standards define terms in a consistent way. Requirements
The requirements of a standard may often be written over a number of sections, dependent upon the nature of the standard; it contains the main technical requirements for the standard. There is an attempt to number sections in logical groups, using multiple levels of numbers; if clause 5 is titled tests, then all requirements in the document related to tests would be expected to be found there, with each test listed as, for example, 5.4, 5.5; each section can then be detailed as 5.4.1, 5.4.2, etc. It is preferable to have clear and singular requirements in each clause, and to keep the text in each numbered section relatively brief, so that reference to a specific clause, and hence requirement, is clear and unambiguous in its reference. Other sections
Other sections may be added, again depending upon the exact nature of the standard. These sections may include labeling, documentation, or instructions, which will give requirements for the need to give specific information in a prescribed format, or may include tests, which give a range of performance test that are required to demonstrate conformity. Annexes
There are usually a series of annexes in a standard. These annexes may be normative or informative. Normative annexes must be complied with to claim or demonstrate conformity to the standard, whereas informative annexes may be giving addition or optional information, or a suggested method of performing a test.
17.10 Accessing the most relevant standards and guidance documents As discussed earlier, standards can be generally described by their origin, i.e., international, European, or national. International and European standards are usually available as national standards after being nationally adopted, so a country’s National Standards Organization (NSO) is often the best source of information on these standards.
17.11 Conclusion and future trends Health care decontamination standards have evolved significantly over the last 20 years; the publication of many European standards within Europe has given a uniform approach from within the European Union. Increasingly, the Vienna Agreement
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has seen many ISO standards adopted as EN ISO standards, giving a globally harmonized approach to decontamination practice. There are, however, still necessary differences between health care practice and industrial practice in the pharmaceutical and medical device areas. These differences stem from the consistent load and consistent process approach used in industry to the variable and potentially unpredictable load approach found in hospitals. These differences will always exist; however increasingly the disparities are being reduced as a consequence of possibly the biggest trend in standardization currently, of using a science-based or evidence-based approach as the basis of standards decision-making. Historically standards evolved from a combination of scientific principles coupled with strong personal views of opinion makers. Many of these principles and views were well founded, and form the basis of common practice found today, but when opportunities exist to rethink or justify a historical approach, an evidence-based or scientific rationale is increasingly required. As more global harmonization occurs within standardization, regional differences in practice become more apparent; for example, within the United States, performance qualification (PQ) of hospital sterilization loads for steam sterilization is rare, with US practitioners preferring routine use of biological monitoring. In contrast, within Europe and Australia, PQ of steam sterilized loads is a common event. In order to be as palatable as possible in all parts of the world, practice standards need to be written at a higher level with correspondingly less prescriptive content than would have been expected at a regional level; this is not as bad as it may sound, as global agreement at this higher level does significantly improve custom and practice, but perhaps more importantly, standards developers like ISO are increasingly drafting global guidance documents that underpin the requirements written into these standards.
Sources of further information and advice A list of NSOs can be obtained from either the CEN website www.cen.eu, or the ISO website www.iso.org. Using the search option on these websites is also helpful to find information on revision or amendments to standards, simply by inserting the standard number (without any prefix). These websites are also useful to track development through the different document stages during revision.
Appendix 1: Standards in decontamination The following list of standards and their titles is a comprehensive list of standards used either directly or indirectly in the field of medical device decontamination. It is not meant to be exhaustive, and as standards evolve on an almost continuous basis, and the reader is urged to check the current status of standards on NSO websites (for example, www.bsigroup.com), as well as the websites of CEN (www.cen.eu) and ISO (www. iso.org). The list is in no particular order; however, standards of a particular series have been grouped together.
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EN ISO 13408-1 Aseptic processing of health care products—Part 1: General requirements EN ISO 13408-2 Aseptic processing of health care products—Part 2: Filtration EN ISO 13408-3 Aseptic processing of health care products—Part 3: Lyophilization EN ISO 13408-4 Aseptic processing of health care products—Part 4: Clean-inplace technologies EN ISO 13408-5 Aseptic processing of health care products—Part 5: Sterilization-in-place EN ISO 13408-6 Aseptic processing of health care products—Part 6: Isolator systems EN ISO 13408-7 Aseptic processing of health care products—Part 7: Aseptic qualification of solid medical devices and combination medical devices EN ISO 13408-8 Aseptic processing of health care products—Part 8: Cell based health care products EN 13824 Sterilization of medical devices—Aseptic processing of liquid medical devices—Requirements EN ISO 11138-1 Sterilization of health care products—Biological indicators— Part 1: General requirements EN ISO 11138-2 Sterilization of health care products—Biological indicators— Part 2: Biological indicators for ethylene oxide sterilization processes EN ISO 11138-3 Sterilization of health care products—Biological indicators— Part 3: Biological indicators for moist heat sterilization processes EN ISO 11138-4 Sterilization of health care products—Biological indicators— Part 6: Biological indicators for dry heat sterilization processes EN ISO 11138-5 Sterilization of health care products—Biological indicators— Part 5: Biological indicators for low-temperature-steam-formaldehyde sterilization EN ISO 11138-7 Sterilization of health care products—Biological indicators— Guidance for the selection, use, and interpretation of results EN ISO 18472 Sterilization of health care products—Biological and chemical indicators—Test equipment EN 867-5 Nonbiological systems for use in sterilizers. Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S EN ISO 11140-1 Sterilization of health care products—Chemical indicators— Part 1: General requirements EN ISO 11140-3 Sterilization of health care products—Chemical indicators— Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test EN ISO 11140-4 Sterilization of health care products—Chemical indicators— Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration ISO 11140-5 Sterilization of health care products—Chemical indicators—Part 5: Class 2 indicators for Bowie and Dick-type air removal tests. EN ISO 15882 Chemical indicators—Guidance on the selection, use, and interpretation of results
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EN ISO 14644-1 Cleanrooms and associated controlled environments— Classification of air cleanliness EN ISO 14644-2 Cleanrooms and associated controlled environments— Specifications for testing and monitoring to prove continued compliance with ISO 14644-1 EN ISO 14644-3 Cleanrooms and associated controlled environments—Test methods EN ISO 14644-4 Cleanrooms and associated controlled environments—Design, construction, and start-up EN ISO 14644-5 Cleanrooms and associated controlled environments—Operations EN ISO 14644-6 Cleanrooms and associated controlled environments—Terms and definitions EN ISO 14644-7 Cleanrooms and associated controlled environments—Separative devices (clean air hoods, glove boxes, isolators and mini-environments) EN ISO 14644-8 Cleanrooms and associated controlled environments— Classification of airborne molecular contamination EN ISO 14644-9 Cleanrooms and associated controlled environments—Part 9: Classification of surface particle cleanliness EN ISO 14644-10 Cleanrooms and associated controlled environments—Part 10: Classification of surface chemical cleanliness ISO 14644-12 Cleanrooms and associated controlled environments—Part N: Classification of air cleanliness by nanoscale particle concentration EN ISO 14698-1 Cleanrooms and associated controlled environments— Biocontamination control—General principles EN ISO 14698-2 Cleanrooms and associated controlled environments— Biocontamination control—Evaluation and interpretation of biocontamination data ISO 20857 Sterilization of health care products—Dry heat—Requirements for the development, validation, and routine control of an industrial sterilization process for medical devices EN ISO 10993-7 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals EN ISO 11135 Sterilization of health care products—Requirements for the development, validation and routine control of a sterilization process for medical devices— Ethylene oxide EN ISO 14160 Sterilization of single-use medical devices incorporating materials of animal origin—Validation and routine control of sterilization by liquid chemical sterilants EN ISO 25424 Sterilization of medical devices—Low temperature steam and formaldehyde—Requirements for development, validation, and routine control of a sterilization process for medical devices ISO 13022:2012 Tissue product safety—Application of risk management to viable materials of human origin used for the production of medical products EN ISO 22442-1 Medical devices utilizing animal tissues and their derivatives— Part 1: Application of risk management
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EN ISO 22442-2 Medical devices utilizing animal tissues and their derivatives— Part 2: Controls on sourcing, collection and handling EN ISO 22442-3 Medical devices utilizing animal tissues and their derivatives— Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents ISO TR 22442-4: 2010, Specific principles of validation assays for elimination/inactivation/removal of transmissible spongiform encephalopathy (TSE) agents (prions) from medical devices using nonviable animal tissues EN ISO 11737-1 Sterilization of medical devices. Microbiological methods. Determination of the population of microorganisms on products EN ISO 11737-2 Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the validation of a sterilization process EN ISO 17665-1 Sterilization of health care products—Requirements for the development, validation, and routine control of a sterilization process for medical devices—Moist heat ISO/TS 17665-2 Sterilization of health care products—Moist heat—Part 2: Guidance on the application of ISO 17665-1 ISO/TS 17665-3 Sterilization of health care products—Steam sterilization—Part 3: Product families EN 868-2 Packaging materials for terminally sterilized medical devices. Part 2: Sterilization wrap—Requirements and test methods EN 868-3 Packaging materials for terminally sterilized medical devices. Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5)—Requirements and test methods EN 868-4 Packaging materials for terminally sterilized medical devices. Part 4: Paper bags— Requirements and test methods EN 868-5 Packaging materials for terminally sterilized medical devices. Part 5: Sealable pouches and reels of porous materials and plastic film construction— Requirements and test methods EN 868-6 Packaging materials for terminally sterilized medical devices. Part 6: Paper for the manufacture of sterile barrier systems intended for sterilization by low temperature sterilization processes or irradiation—Requirements and test methods EN 868-7 Packaging materials for terminally sterilized medical devices. Part 7: Adhesive coated paper for the manufacture sealable packs for medical use for sterilization by ethylene oxide or irradiation—Requirements and test methods EN 868-8 Packaging materials for terminally sterilized medical devices. Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285— Requirements and test methods EN 868-9 Packaging materials for terminally sterilized medical devices. Part 9: Uncoated nonwoven materials of polyolefines for use in the manufacture of sealable pouches, reels, and lids—Requirements and test methods EN 868-10 Packaging materials for terminally sterilized medical devices. Part 10: Adhesive coated nonwoven materials of polyolefines for use in the manufacture of sealable pouches, reels, and lids—Requirements and test methods
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EN ISO 11607-1 Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems, and packaging systems EN ISO 11607-2 Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing, and assembly processes ISO/TS 16775 Packaging for terminally sterilized medical devices—Guidance on the application of ISO 11607-1and ISO 11607-2 EN ISO 11137-1 Sterilization of health care products—Requirements for the development, validation and routine control of a sterilization process for medical devices—Radiation—Part 1: Requirements EN ISO 11137-2 Sterilization of health care products—Requirements for the development, validation and routine control of a sterilization process for medical devices—Radiation—Part 2: Establishing the sterilization doses EN ISO 11137-3 Sterilization of health care products—Requirements for the development, validation and routine control of a sterilization process for medical devices—Radiation—Part 3: Guidance on dosimetric aspects EN ISO 17664-1 Sterilization of medical devices—Information to be provided by the supplier for the reprocessing of resterilizable devices EN ISO 11139 Sterilization of health care products—Vocabulary EN 556-1 Sterilization of medical devices—Requirements for medical devices to be designated “STERILE”—Part 1: Requirements for terminally sterilized medical devices EN 556-2 Sterilization of medical devices. Requirements for medical devices to be designated “STERILE”—Part 2: Requirements for aseptically processed medical devices EN ISO 14937 Sterilization of health care products—General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process EN 285 Sterilization. Steam sterilizers. Large Sterilizers EN 13060 Sterilization. Steam sterilizers. Small Sterilizers EN 1422 Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods EN 14180 Sterilizers for medical purposes—Low temperature steam and formaldehyde sterilizers—Requirements and testing IEC 61010-2-040 Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 2-040: Particular requirements for sterilizers and washer disinfectors used to treat medical materials EN ISO 15883-1 Washer-disinfectors. General requirements, terms and definitions and tests EN ISO 15883-2 Washer-disinfectors. Requirements and tests for washer- disinfectors employing thermal disinfection for surgical instruments, anesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. EN ISO 15883-3 Washer-disinfectors, Part 3: Requirements and tests for washer-disinfectors for human waste containers EN ISO 15883-4 Washer-disinfectors—Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
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ISO/TS 15883-5 Washer-disinfectors—Part 5: Test soils and methods for demonstrating cleaning efficacy EN ISO 15883-6 Washer-disinfectors—Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for noninvasive, noncritical medical devices and healthcare equipment EN ISO 15883-7 Washer-disinfectors—Part 7: Requirements and tests for general purpose washer-disinfectors employing chemical disinfection for bedframes, bedside tables, transport carts, containers, surgical tables, furnishings, and surgical clogs EN 16442 Controlled environment storage cabinet for disinfected thermolabile endoscopes
References [1] ISO Vienna Agreement, ISO, Geneva. https://isotc.iso.org/livelink/livelink/fetch/2000/ 2122/3146825/4229629/4230450/4230458/customview.html?func=ll&objId= 4230458&objAction=browse&sort=subtype. [2] ISO Directives, Part 1, ISO, Geneva. https://isotc.iso.org/livelink/livelink?func=ll&objId= 4230452&objAction=browse&sort=subtype. [3] ISO Directives, Part 2, ISO, Geneva. https://isotc.iso.org/livelink/livelink?func=ll&objId= 4230456&objAction=browse&sort=subtype. [4] CEN BOSS, CEN, Brussels. https://boss.cen.eu/Pages/default.aspx.
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R. Bancroft STERIS Corporation, Leicester, United Kingdom
17.1 Introduction A standard is a technical document, drafted by recognized standards bodies, that seeks to establish standardized specifications, requirements and practices. They are used in decontamination to help ensure that medical devices, materials, and processes are fit for purpose, i.e., safe, reliable, and of appropriate quality. In an increasingly regulated environment, decontamination makes extensive use of these documents to allow practitioners and manufacturers to follow and hence claim conformity to these established criteria for the purposes of minimizing errors across geographic or technical areas, and helping to ensure alignment and common understanding. Standards help to eliminate trade barriers to allow free and fair trade and form a common “language” between users of such documents. All of these standards, with the exception of private standards, are publicly available documents, usually for a fee. They have been written on the premise of consensus by multidisciplinary groups of people, and have been developed in a formal and structured way. This development structure allows for open consultation at prescribed stages and culminates in a formal approval of the document prior to publication. Standards play a key role in practice for medical device decontamination in the healthcare and medical device industrial areas and act as a route to compliance with legal requirements. In Germany, a standard is known as a norm, whereas in France, a standard is known as a norme.
17.2 Relationship of standards to law and guidance Standards are generally written as voluntary requirements, and hence are not intended directly to be mandatory. However, standards are often used as a route to compliance to requirements that may be mandatory and as such, standards have a very important role. The regulatory structure and requirements in different parts of the world clearly differ, but at a top-level perspective, there is much commonality. Every country has its own national laws, which of course vary from country to country. Within Europe, there is much commonality, with EU legislation being implemented either directly by way of a European Regulation, or into EU member state’s law through European Directives. European Directives are legislative acts of the European Union and are used to achieve a particular result without dictating the means Decontamination in Hospitals and Healthcare. https://doi.org/10.1016/B978-0-08-102565-9.00017-0 © 2020 Elsevier Ltd. All rights reserved.
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of achieving that result, and allow EU member states a certain element of leeway as to exactly how it is adopted into national law. European Regulations, however, are self-executing and do not require any implementing measures, and become immediately enforceable as law in all EU member states. EU Regulations and Directives are written by EU commissioners and are legal instruments within Europe, and form the basis for much European law, and are required to be implemented into each of the 28 EU member states. Much has changed in the case of the medical device legislation in the EU; the EU Medical Devices Directive 93/42/EEC, modified by the 2007/47/EC amending directive, is being replaced by Regulation (EU) 2017/745, with an implementation date of 26th May 2020. This new regulation combines the General Medical Device Directive, 93/42/EEC, with the Active Implantable Medical Device Directive, 90/385/EEC. As a consequence of these changes, many current standards are being harmonized against the new regulation, and many current standards will be updated as a consequence. These regulations place obligations on manufacturers and other economic operators (legal entities responsible for bringing a product to the market) to ensure that devices are safe and fit for their intended purpose, and are worded in a particular legal style. The salient part of these new regulations are the general safety and performance requirements (GSPRs—formerly known as Essential Requirements—ERs—in the Medical Devices Directive) that form the basis of a minimum standard for safety, allowing for free (without hindrance) interstate commerce within the EU, i.e., without trade barriers. Compliance with the ERs or GSPRs of this (and other applicable EU Regulations or Directives) allows for affixing of the CE mark. As the CE mark confers conformity with the General Safety and Performance Requirements or Essential Requirements of applicable regulations or directives respectively, the CE mark means that a device meets the minimum safety requirements and hence can be sold throughout Europe, theoretically without any further barrier to trade. As these form the basis for EU law, the text is often written at a high level and is nonspecific; however European Regulations such as the Medical Devices Regulation are much more specific and detailed than their predecessors. Within the United States, the decontamination of medical devices within hospitals is not directly controlled by the US Food and Drug Administration (FDA); however manufacturers of such devices are subject to control by FDA and Title 21 of the Code of Federal Regulations (21 CFR). Section 18 in Chapter 1 of 21 CFR covers the requirements for medical devices. In Australia, medical devices have their legal basis in the Therapeutic Goods Act. The legal requirements and their implementation in these geographical areas are clearly different; however each statutory law must be practically enacted; these legal documents tend to be quite general in their verbiage, and so a more specific interpretation of these legal requirements is often sought. Standards are often used in this way; however there does need to be a link between the statutory law and the standard; in Australia, this mechanism is by a Medical Device Standards Order (MDSO). In the United States, medical device manufacturers may choose to use the FDA Recognized Consensus Standard route to obtain a premarket (510(k)) clearance to legally market
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a medical device; hence showing conformity to a recognized consensus standard can greatly expedite premarket clearance. Practitioners and manufacturers within Europe may use the table in Annex Z of one or more harmonized European standards (see European standards below) to show, within the limits of the scope of the harmonized standard, a presumption of conformity with the corresponding Essential Requirements of an applicable European Directive or the General Safety and Performance Requirements of an applicable European Regulation. This means that if this method is used, compliance with the Essential Principles or Conformity Assessment Procedures that the requirements of the standard have been deemed to address is assumed. As we progress down the hierarchy shown in Fig. 17.1, requirements generally become more specific; in the case of guidance documents, these tend to give a recommended course of action to enable compliance with the standards that they support. This more prescriptive approach tends to be more geographically relevant, making use of regional or national custom and practice. Finally, local procedures are the documented method statements applicable to local areas or even facilities that again support the requirements of the standards and ultimately local law (see Chapter 18). It is quite usual that practitioners and manufacturers will largely resort to standards and guidance documents in order to formulate their local procedures, rather than making specific use of the legal requirements, although a basic understanding of the law is generally assumed. These procedures are nonmandatory, but are generally accepted as the best method to demonstrate compliance, ultimately, with the legal requirements.
Fig. 17.1 Schematic of the similar relationship of standards to legal requirements in Australia, Europe and the United States.
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17.3 Key aims and principles of standards Standards are not necessarily mandatory or do not have a direct legal obligation, but they do form the basis of “best practice”—a methodology that, through experience and research, has proven to reliably lead to a desired result. This usually results in a pragmatic direction that allows a clear interpretation of the legal requirements. In order to be accepted as a standard, a number of key principles are expected; first, the standard must be publicly available and published by a recognized body; the development of the standard should consist of a drafting group ideally comprising of expert practitioners, manufacturers, and regulators, and approval of the standard should have been by consultation from all interested parties, hence are often referred to as consensus standards due to their consensus-driven drafting and approval. Increasingly, there are expectations (or in the case of Europe, legal considerations) that standards should not be design restrictive; as long as the outcomes or requirements are stated, how we get there should not be specified. While in principle this is satisfactory, there are practical issues to consider; let us imagine a sterilization scenario where there is a clear and necessary requirement that sterilant penetrates all parts of the load to be sterilized. It would be expected that a standard would specify a specific test method as part of operational qualification (OQ) in order to verify this; however it may be argued that using a standard method is unnecessarily design restrictive, and as long as performance qualification (PQ) justifies sterilant penetration into the load, then this is acceptable. In practice many standards are written where the test methods used to demonstrate a particular attribute are informative (i.e., not normative) parts of the standard in order to prevent the EU rejecting a standard as being design restrictive; however the general feeling is that standards should be written to be as prescriptive as possible.
17.4 Types of standards There are two significant types of standards based on content; these are referred to as standards, consisting typically of what one would expect of a standard by way of requirements, plus technical reports or technical specifications. Standards consist of principally “normative” text, text that is mandatory if compliance to the standard is claimed, and “informative” text, used to explain or justify the normative parts of the document, or parts of the document that are optional or for guidance. When referring to types of standards, however, reference is usually being made to the type of standard with respect to the developer; four types of standard are generally available. These consist of private, national, European, and international standards. Private standards are usually written for a commercial entity or group of entities, and are commissioned for a specific purpose; however as these are, by definition, not publicly available, no further discussion will be made here of this type of standard. Guidance documents may be described as standards; however guidance documents are written in a different style to performance standards; the whole text of guidance is written using terms such as should (rather than the assertive shall that is used in
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normative text), highlighting the optional nature of guidance documents. Guidance documents are, however, more prescriptive in terms of how they describe an action. Typically, the expectation is that guidance documents underpin the normative requirements of a standard (see Section 17.2). International, European, and national standards are discussed in more detail below.
17.5 Vienna agreement In order to prevent duplication of work between CEN and ISO, the agreement on technical cooperation between CEN and ISO of 1991 (Vienna Agreement), revised in 2001, was implemented [1]. The Vienna Agreement recognizes the primacy of international (ISO) standards, and aims to approve in parallel international and European standards. CEN or ISO can take the lead in drafting a new standard and will be presented for simultaneous approval by both standards bodies, and synchronized to achieve the objective of simultaneous publication. The important point is that the standards development is done in either ISO or CEN, and then sent for parallel ballot with member bodies of both CEN and ISO. This clearly means that ISO members can influence content of CEN standards and vice versa, however the Vienna Agreement does specifically allow CEN or ISO to work on the same subject, if deemed necessary. The latest revision (3.3) of the Vienna Agreement gives priority to international standardization, and lends greater importance to ISO leadership than did the previous versions, although there is generally close liaison with CEN members during this process, for example CEN commits to respond adequately to comments from the non-CEN ISO members.
17.6 European standards EN standards are developed by CEN (European Committee for Standardization), based in Brussels, Belgium, and formed in 1975. European standards are also published by CENELEC (European Committee for Electrotechnical Standardization) and ETSI (European Telecommunications Standards Institute); however these standards are not directly used in the area of medical device decontamination (although some CENELEC standards give electrical safety requirements that can be applied to equipment such as sterilizers and washer-disinfectors). CEN standards, like other standards, are voluntary standards, however increasingly support EU policies and legislation. Under European Law, a European standard has to be implemented into each EU state in an unaltered form and any conflicting national standards withdrawn. These standards can afford to be much more prescriptive than Directives or Regulations, and are generally deemed to be considered “best practice.” EU standards can either be “harmonized” or not. The term “harmonized” is often misunderstood; this refers to harmonization within legislation, against a specified directive or directives (as opposed to
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being “harmonized” across all 28 EU member states plus the EFTA states—a requirement of any European standard). Harmonized standards provide a means of conforming to Essential Requirements of specified Regulations or Directives; once the standard has been cited in the Official Journal of the European Union (OJEU), compliance with the certain clauses of the standard provide a presumption of conformity with corresponding Essential Requirements or General Safety and Performance Requirements of specified Directives or Regulations. Harmonized standards are recognized by the presence of one or more annex Zs that include a table which cross references every clause of the Essential Requirements or General Safety and Performance Requirements of the appropriate Directive or Regulation with clauses of the standard. In addition to the presence of these annex Zs, the standard must also be cited in the OJEU. Multiple annex Zs are used to cross reference to other Directives or Regulations; for example, a piece of decontamination equipment may fall under Directives or Regulations for medical devices, machinery, low voltage, electromagnetic emissions, etc. Hence multiple annex Zs may appear in a harmonized standard to enable the standards to be used as a way of demonstrating compliance with the applicable parts of all relevant Directives or Regulations. European standards must be published as national standards within all the EU member states plus the EFTA countries (Iceland, Liechtenstein, Norway, and Switzerland). When these standards are implemented, any national standards that have similar scope must be withdrawn. When EN standards are nationally implemented, they are numbered with the EU member state NSO prefix, so for example in Germany, an EN standard would be prefixed DIN EN followed by the EN number. It is increasingly common that ISO standards are adopted under the Vienna Agreement, hence CEN-adopted ISO documents would be labeled as DIN EN ISO followed by the ISO number in Germany.
17.7 International standards ISO standards are developed by the International Organization for Standardization (ISO). ISO is a network of over 160 national standards organizations (NSOs) with a Central Secretariat in Geneva, Switzerland. ISO is the world’s largest developer of voluntary international standards. International standards give state of the art specifications for products, services, and good practice, helping to make industry more efficient and effective. Developed through global consensus, they help to break down barriers to international trade. The ISO NSOs can adopt standards as national standards; hence in the United Kingdom they would become prefixed as BS ISO followed by the ISO number, or as ANSI/AAMI/ISO in the United States, for example. There is no requirement for an NSO to adopt an ISO standard, and they can in addition be nationally modified, so if France does not like a particular requirement, for example, this could be deleted in the French (NF ISO) national implementation.
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17.8 How standards are drafted The process of standards development follows a prescribed and well-established process. This process is similar for ISO [2, 3], CEN [4], and national standards. Generally, before work can begin on a standard, a New Work Item Proposal (NWIP) is required. This is, in reality, a draft or outline of a standard that is submitted by a National Standards Body (NSB), for example, BSI, to CEN or ISO, and is then balloted by applicable NSBs. Participation in standards development should be by knowledgeable people who represent users, regulators, and manufacturers; participation at EU or ISO level is “representation by country”, i.e., participants should represent views of their nation. Proposals are adopted if two thirds of the votes are in favor, as long as there are not more than one quarter of the votes against. ISO and CEN do differ in their approach to voting; each ISO member country (NSO) has a single vote each, whereas CEN utilizes weighted voting. CEN weighted voting is based on the population size of each country. There are 34 countries that vote on CEN standards; the 28 members of the EU, plus 6 additional countries from within the European Free Trade Association (EFTA) and the EU Single Market countries (Table 17.1). It is expected that the anticipated departure of the United Kingdom from the EU will not change its input into the CEN voting process. Proposals are adopted if 71.00% or more of the weighted votes cast are in favor of the standard (abstentions are not counted). The United Kingdom, being one of the more populous countries in the EU, is one of five countries with the highest weighted vote.
17.8.1 Standards development timescale The established standards development process must allow comments and voting at critical document stages; as such, the process is often viewed as slow and laborious; however it does yield a quality consensus output. Table 17.1 CEN weighted voting by country. Country
Vote weighting per country
Germany, France, the United Kingdom, Italy, Turkey Spain, Poland Romania The Netherlands Belgium, Czech Republic, Greece, Hungary, Portugal Austria, Switzerland, Sweden, Bulgaria Denmark, Finland, Ireland, Lithuania, Norway, Slovakia, Croatia, Serbia Cyprus, Estonia, Latvia, Luxembourg, Slovenia, Republic of North Macedonia Iceland, Malta
29 votes 27 votes 14 votes 13 votes 12 votes 10 votes 7 votes 4 votes 3 votes
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There are a series of formal stages that a document must progress through (Table 17.2). The stages are similar for CEN and ISO documents with one notable exception; the committee stage, commonly known as the CD (committee draft) stage in ISO, does not exist in CEN. The consequence of this is that the document progresses directly from WD (working draft) to prEN stages within CEN, whereas in ISO the document would go through the intermediate CD stage. CEN distributes the enquiry and approval documents in CEN’s 3 official languages—English, French, and German. All document stages allow for national comments to be submitted, with the exception of the approval (final vote) stage, where no comments are normally permitted, and it is simply a yes/no vote, although obvious errors or typographical errors will be corrected. At this stage, it is anticipated that there will be an affirmative vote, based on earlier votes and comments. If the committee or enquiry results indicate (either by comment or by vote) that there is significant dissatisfaction with the document, it is possible to repeat that document stage with a revised document. The timelines specified (Table 17.2) are typical times, as CEN and ISO now promote flexibility in the time taken for individual document stages, in an attempt to expedite document publication. Each stage needs preparatory time before and after each stage in order to ready documents for distribution or to circulate voting results and comments; this preparation time can be in the order of 2 or 3 months. Working group (WG) meetings need to be organized to review results and provide resolutions to comments made on the document. All comments submitted on a document draft must have a response provided by the working group. The working group meetings need to be arranged and agreed by the majority of participants if the meetings are to be productive. Typical standard development timelines from NWIP to approval are expected to be completed within 3 years; development of a standard may be less than this time period if the development is a relatively simple revision of an existing standard; however major revisions can take much longer. ISO recognizes development timelines from 18 to 48 months; failure to meet the agreed timelines can result in a work item being canceled. If there is consensus to continue the work, it will need to be restarted again by approval of an NWIP. Once the standard is implemented, a framework is in place to ensure the standards are continuously reviewed and updated where appropriate. Table 17.2 Standards document stages in CEN and ISO. Document stage
CEN terminology
ISO terminology
Usual stage timeline
Proposal
NWIP
NWIP
Preparatory Committee
WD [None]
WD CD
Enquiry Approval (Final Vote)
prEN FprEN
DIS FDIS
3 months for ballot (but can be shortened to 2 months) Variable 2 months (but can be 3 or 4 months) 3 months 2 months
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All standards are subject to a systematic review at least every 5 years; at this review, three options are available. A standard can be confirmed, meaning that no changes are required, and will next be reviewed in another 5 years; it can be revised, allowing for a new edition to be created, following the process above for standards development. The final option is withdrawal of the standard if it is felt that the standard is no longer useful or current. Amendments may be made to a standard. Amendments are generally issued as a supplementary document, with the intention that they are read in conjunction with the original (current) standard. Amendments can be combined into the original standard, in which case they are referred to in the document number, for example EN XXX:2006 + A2:2009, here noting a second amendment in 2009, amending a document published in 2006. Amendments will go through the usual formal document approval procedure outlined above. Publishing errors are termed corrigenda and are used to correct printing, linguistic, and editorial errors. The existence of a corrigendum should be made known to all users of a standard, hence highlighting the need to verify the current status of a standard via CEN or ISO websites (see “Sources of further information and advice” section). Corrigenda are not usually subject to formal approval procedures and hence can be issued relatively quickly.
17.8.2 Providing comments, corrections, and improvements to standards The speed and efficiency of working group meetings can be greatly enhanced by the quality of comments provided on a document; ISO and CEN use identical comment template documents. These comments must be submitted to CEN or ISO via the respective NSO; for example, comments from the United Kingdom would be submitted to BSI, who would collate and agree them, prior to submitting to CEN or ISO. Comments provided on documents must be clear and concise, correctly reference the clause or clauses that are being addressed, and (most importantly) provide alternative (suggested) text. If a comment is provided that states “this section is unclear; please reword,” it is unlikely that the working group will spend much time deliberating the comment.
17.9 How to read and understand a standard Standards are written using very deliberate language; they are not meant to be works of literary brilliance; so it is not uncommon to see, for example, repetitive text or strange sentence construction that is used to ensure that there is no ambiguity in the requirements given. The language used in a standard depends upon the nature of the section; standards use the term “shall” in order to show mandatory or normative requirements, for example, or “should” to show guidance or optional informative text. If a product or service claims conformity to a standard, it must comply with every requirement in that
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standard, i.e., a claim to conformity is an absolute. Partial c onformity is generally not appropriate. The sections of a standard are normally prepared in a consistent format and usually contain the following sections: Title
The title of a standard is simply to identify the standard to interested parties, so needs to capture simply and explicitly the nature of the standard. Foreword
The foreword is used to describe who was involved (by committee title) in drafting the standard, and any interrelationship with other parts (if one of a series) of standards, or other parts. Introduction
This introduces the context of the standard, but has little formal relevance to the requirements of the standard. Scope
The scope is one of the most important sections of a standard, and is arguably more important than the title; the scope details the inclusions (and sometimes the exclusions) of the standard, what is actually specified and to whom the standard is aimed at (manufacturer, practitioner, etc.). Normative references
The normative references are simply a list of (usually) other standards that are cited in a normative way within the standard, i.e., compliance with this standard is not possible without compliance with some or all of the requirements of other standards that are cited in the normative references. Care must be taken in this area, however, as there can be a chain of normative requirements if the normatively referred standard does itself have normative requirements; this chain can invoke many additional requirements over several standards. Notes
Notes can be used throughout the standard. They are easy to identify as they are preceded by the word “note.” Notes are used to clarify meaning of the text, and cannot modify the requirements specified. As such, they are considered to be informative rather than normative parts of the standard. Terms and definitions
Definitions in a standard are not meant to serve as a dictionary or encyclopedia to a casual reader; they are often used as scientific terms with a very specific meaning. Definitions are only relevant to the standard to which they relate, and simplify and abbreviate the standard by allowing a simple term or definition to have a sometimes long and complicated meaning. There are always attempts to ensure that the same terms used in a series or area of standardization have the same definition, in order to minimize any possible confusion. For example, the term “fault” may have a very particular
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definition within a given standard, and this meaning may not be necessarily the same as a lay persons’ understanding, or a dictionary definition, of the same term, although there is always an attempt to align definitions within a given subject area, so that, for example, health care standards define terms in a consistent way. Requirements
The requirements of a standard may often be written over a number of sections, dependent upon the nature of the standard; it contains the main technical requirements for the standard. There is an attempt to number sections in logical groups, using multiple levels of numbers; if clause 5 is titled tests, then all requirements in the document related to tests would be expected to be found there, with each test listed as, for example, 5.4, 5.5; each section can then be detailed as 5.4.1, 5.4.2, etc. It is preferable to have clear and singular requirements in each clause, and to keep the text in each numbered section relatively brief, so that reference to a specific clause, and hence requirement, is clear and unambiguous in its reference. Other sections
Other sections may be added, again depending upon the exact nature of the standard. These sections may include labeling, documentation, or instructions, which will give requirements for the need to give specific information in a prescribed format, or may include tests, which give a range of performance test that are required to demonstrate conformity. Annexes
There are usually a series of annexes in a standard. These annexes may be normative or informative. Normative annexes must be complied with to claim or demonstrate conformity to the standard, whereas informative annexes may be giving addition or optional information, or a suggested method of performing a test.
17.10 Accessing the most relevant standards and guidance documents As discussed earlier, standards can be generally described by their origin, i.e., international, European, or national. International and European standards are usually available as national standards after being nationally adopted, so a country’s National Standards Organization (NSO) is often the best source of information on these standards.
17.11 Conclusion and future trends Health care decontamination standards have evolved significantly over the last 20 years; the publication of many European standards within Europe has given a uniform approach from within the European Union. Increasingly, the Vienna Agreement
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has seen many ISO standards adopted as EN ISO standards, giving a globally harmonized approach to decontamination practice. There are, however, still necessary differences between health care practice and industrial practice in the pharmaceutical and medical device areas. These differences stem from the consistent load and consistent process approach used in industry to the variable and potentially unpredictable load approach found in hospitals. These differences will always exist; however increasingly the disparities are being reduced as a consequence of possibly the biggest trend in standardization currently, of using a science-based or evidence-based approach as the basis of standards decision-making. Historically standards evolved from a combination of scientific principles coupled with strong personal views of opinion makers. Many of these principles and views were well founded, and form the basis of common practice found today, but when opportunities exist to rethink or justify a historical approach, an evidence-based or scientific rationale is increasingly required. As more global harmonization occurs within standardization, regional differences in practice become more apparent; for example, within the United States, performance qualification (PQ) of hospital sterilization loads for steam sterilization is rare, with US practitioners preferring routine use of biological monitoring. In contrast, within Europe and Australia, PQ of steam sterilized loads is a common event. In order to be as palatable as possible in all parts of the world, practice standards need to be written at a higher level with correspondingly less prescriptive content than would have been expected at a regional level; this is not as bad as it may sound, as global agreement at this higher level does significantly improve custom and practice, but perhaps more importantly, standards developers like ISO are increasingly drafting global guidance documents that underpin the requirements written into these standards.
Sources of further information and advice A list of NSOs can be obtained from either the CEN website www.cen.eu, or the ISO website www.iso.org. Using the search option on these websites is also helpful to find information on revision or amendments to standards, simply by inserting the standard number (without any prefix). These websites are also useful to track development through the different document stages during revision.
Appendix 1: Standards in decontamination The following list of standards and their titles is a comprehensive list of standards used either directly or indirectly in the field of medical device decontamination. It is not meant to be exhaustive, and as standards evolve on an almost continuous basis, and the reader is urged to check the current status of standards on NSO websites (for example, www.bsigroup.com), as well as the websites of CEN (www.cen.eu) and ISO (www. iso.org). The list is in no particular order; however, standards of a particular series have been grouped together.
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EN ISO 13408-1 Aseptic processing of health care products—Part 1: General requirements EN ISO 13408-2 Aseptic processing of health care products—Part 2: Filtration EN ISO 13408-3 Aseptic processing of health care products—Part 3: Lyophilization EN ISO 13408-4 Aseptic processing of health care products—Part 4: Clean-inplace technologies EN ISO 13408-5 Aseptic processing of health care products—Part 5: Sterilization-in-place EN ISO 13408-6 Aseptic processing of health care products—Part 6: Isolator systems EN ISO 13408-7 Aseptic processing of health care products—Part 7: Aseptic qualification of solid medical devices and combination medical devices EN ISO 13408-8 Aseptic processing of health care products—Part 8: Cell based health care products EN 13824 Sterilization of medical devices—Aseptic processing of liquid medical devices—Requirements EN ISO 11138-1 Sterilization of health care products—Biological indicators— Part 1: General requirements EN ISO 11138-2 Sterilization of health care products—Biological indicators— Part 2: Biological indicators for ethylene oxide sterilization processes EN ISO 11138-3 Sterilization of health care products—Biological indicators— Part 3: Biological indicators for moist heat sterilization processes EN ISO 11138-4 Sterilization of health care products—Biological indicators— Part 6: Biological indicators for dry heat sterilization processes EN ISO 11138-5 Sterilization of health care products—Biological indicators— Part 5: Biological indicators for low-temperature-steam-formaldehyde sterilization EN ISO 11138-7 Sterilization of health care products—Biological indicators— Guidance for the selection, use, and interpretation of results EN ISO 18472 Sterilization of health care products—Biological and chemical indicators—Test equipment EN 867-5 Nonbiological systems for use in sterilizers. Specification for indicator systems and process challenge devices for use in performance testing for small sterilizers Type B and Type S EN ISO 11140-1 Sterilization of health care products—Chemical indicators— Part 1: General requirements EN ISO 11140-3 Sterilization of health care products—Chemical indicators— Part 3: Class 2 indicator systems for use in the Bowie and Dick-type steam penetration test EN ISO 11140-4 Sterilization of health care products—Chemical indicators— Part 4: Class 2 indicators as an alternative to the Bowie and Dick-type test for detection of steam penetration ISO 11140-5 Sterilization of health care products—Chemical indicators—Part 5: Class 2 indicators for Bowie and Dick-type air removal tests. EN ISO 15882 Chemical indicators—Guidance on the selection, use, and interpretation of results
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EN ISO 14644-1 Cleanrooms and associated controlled environments— Classification of air cleanliness EN ISO 14644-2 Cleanrooms and associated controlled environments— Specifications for testing and monitoring to prove continued compliance with ISO 14644-1 EN ISO 14644-3 Cleanrooms and associated controlled environments—Test methods EN ISO 14644-4 Cleanrooms and associated controlled environments—Design, construction, and start-up EN ISO 14644-5 Cleanrooms and associated controlled environments—Operations EN ISO 14644-6 Cleanrooms and associated controlled environments—Terms and definitions EN ISO 14644-7 Cleanrooms and associated controlled environments—Separative devices (clean air hoods, glove boxes, isolators and mini-environments) EN ISO 14644-8 Cleanrooms and associated controlled environments— Classification of airborne molecular contamination EN ISO 14644-9 Cleanrooms and associated controlled environments—Part 9: Classification of surface particle cleanliness EN ISO 14644-10 Cleanrooms and associated controlled environments—Part 10: Classification of surface chemical cleanliness ISO 14644-12 Cleanrooms and associated controlled environments—Part N: Classification of air cleanliness by nanoscale particle concentration EN ISO 14698-1 Cleanrooms and associated controlled environments— Biocontamination control—General principles EN ISO 14698-2 Cleanrooms and associated controlled environments— Biocontamination control—Evaluation and interpretation of biocontamination data ISO 20857 Sterilization of health care products—Dry heat—Requirements for the development, validation, and routine control of an industrial sterilization process for medical devices EN ISO 10993-7 Biological evaluation of medical devices—Part 7: Ethylene oxide sterilization residuals EN ISO 11135 Sterilization of health care products—Requirements for the development, validation and routine control of a sterilization process for medical devices— Ethylene oxide EN ISO 14160 Sterilization of single-use medical devices incorporating materials of animal origin—Validation and routine control of sterilization by liquid chemical sterilants EN ISO 25424 Sterilization of medical devices—Low temperature steam and formaldehyde—Requirements for development, validation, and routine control of a sterilization process for medical devices ISO 13022:2012 Tissue product safety—Application of risk management to viable materials of human origin used for the production of medical products EN ISO 22442-1 Medical devices utilizing animal tissues and their derivatives— Part 1: Application of risk management
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EN ISO 22442-2 Medical devices utilizing animal tissues and their derivatives— Part 2: Controls on sourcing, collection and handling EN ISO 22442-3 Medical devices utilizing animal tissues and their derivatives— Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents ISO TR 22442-4: 2010, Specific principles of validation assays for elimination/inactivation/removal of transmissible spongiform encephalopathy (TSE) agents (prions) from medical devices using nonviable animal tissues EN ISO 11737-1 Sterilization of medical devices. Microbiological methods. Determination of the population of microorganisms on products EN ISO 11737-2 Sterilization of medical devices. Microbiological methods. Tests of sterility performed in the validation of a sterilization process EN ISO 17665-1 Sterilization of health care products—Requirements for the development, validation, and routine control of a sterilization process for medical devices—Moist heat ISO/TS 17665-2 Sterilization of health care products—Moist heat—Part 2: Guidance on the application of ISO 17665-1 ISO/TS 17665-3 Sterilization of health care products—Steam sterilization—Part 3: Product families EN 868-2 Packaging materials for terminally sterilized medical devices. Part 2: Sterilization wrap—Requirements and test methods EN 868-3 Packaging materials for terminally sterilized medical devices. Part 3: Paper for use in the manufacture of paper bags (specified in EN 868-4) and in the manufacture of pouches and reels (specified in EN 868-5)—Requirements and test methods EN 868-4 Packaging materials for terminally sterilized medical devices. Part 4: Paper bags— Requirements and test methods EN 868-5 Packaging materials for terminally sterilized medical devices. Part 5: Sealable pouches and reels of porous materials and plastic film construction— Requirements and test methods EN 868-6 Packaging materials for terminally sterilized medical devices. Part 6: Paper for the manufacture of sterile barrier systems intended for sterilization by low temperature sterilization processes or irradiation—Requirements and test methods EN 868-7 Packaging materials for terminally sterilized medical devices. Part 7: Adhesive coated paper for the manufacture sealable packs for medical use for sterilization by ethylene oxide or irradiation—Requirements and test methods EN 868-8 Packaging materials for terminally sterilized medical devices. Part 8: Re-usable sterilization containers for steam sterilizers conforming to EN 285— Requirements and test methods EN 868-9 Packaging materials for terminally sterilized medical devices. Part 9: Uncoated nonwoven materials of polyolefines for use in the manufacture of sealable pouches, reels, and lids—Requirements and test methods EN 868-10 Packaging materials for terminally sterilized medical devices. Part 10: Adhesive coated nonwoven materials of polyolefines for use in the manufacture of sealable pouches, reels, and lids—Requirements and test methods
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EN ISO 11607-1 Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems, and packaging systems EN ISO 11607-2 Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing, and assembly processes ISO/TS 16775 Packaging for terminally sterilized medical devices—Guidance on the application of ISO 11607-1and ISO 11607-2 EN ISO 11137-1 Sterilization of health care products—Requirements for the development, validation and routine control of a sterilization process for medical devices—Radiation—Part 1: Requirements EN ISO 11137-2 Sterilization of health care products—Requirements for the development, validation and routine control of a sterilization process for medical devices—Radiation—Part 2: Establishing the sterilization doses EN ISO 11137-3 Sterilization of health care products—Requirements for the development, validation and routine control of a sterilization process for medical devices—Radiation—Part 3: Guidance on dosimetric aspects EN ISO 17664-1 Sterilization of medical devices—Information to be provided by the supplier for the reprocessing of resterilizable devices EN ISO 11139 Sterilization of health care products—Vocabulary EN 556-1 Sterilization of medical devices—Requirements for medical devices to be designated “STERILE”—Part 1: Requirements for terminally sterilized medical devices EN 556-2 Sterilization of medical devices. Requirements for medical devices to be designated “STERILE”—Part 2: Requirements for aseptically processed medical devices EN ISO 14937 Sterilization of health care products—General requirements for characterization of a sterilizing agent and the development, validation, and routine control of a sterilization process EN 285 Sterilization. Steam sterilizers. Large Sterilizers EN 13060 Sterilization. Steam sterilizers. Small Sterilizers EN 1422 Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods EN 14180 Sterilizers for medical purposes—Low temperature steam and formaldehyde sterilizers—Requirements and testing IEC 61010-2-040 Safety requirements for electrical equipment for measurement, control, and laboratory use—Part 2-040: Particular requirements for sterilizers and washer disinfectors used to treat medical materials EN ISO 15883-1 Washer-disinfectors. General requirements, terms and definitions and tests EN ISO 15883-2 Washer-disinfectors. Requirements and tests for washer- disinfectors employing thermal disinfection for surgical instruments, anesthetic equipment, bowls, dishes, receivers, utensils, glassware, etc. EN ISO 15883-3 Washer-disinfectors, Part 3: Requirements and tests for washer-disinfectors for human waste containers EN ISO 15883-4 Washer-disinfectors—Part 4: Requirements and tests for washer-disinfectors employing chemical disinfection for thermolabile endoscopes
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ISO/TS 15883-5 Washer-disinfectors—Part 5: Test soils and methods for demonstrating cleaning efficacy EN ISO 15883-6 Washer-disinfectors—Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for noninvasive, noncritical medical devices and healthcare equipment EN ISO 15883-7 Washer-disinfectors—Part 7: Requirements and tests for general purpose washer-disinfectors employing chemical disinfection for bedframes, bedside tables, transport carts, containers, surgical tables, furnishings, and surgical clogs EN 16442 Controlled environment storage cabinet for disinfected thermolabile endoscopes
References [1] ISO Vienna Agreement, ISO, Geneva. https://isotc.iso.org/livelink/livelink/fetch/2000/ 2122/3146825/4229629/4230450/4230458/customview.html?func=ll&objId= 4230458&objAction=browse&sort=subtype. [2] ISO Directives, Part 1, ISO, Geneva. https://isotc.iso.org/livelink/livelink?func=ll&objId= 4230452&objAction=browse&sort=subtype. [3] ISO Directives, Part 2, ISO, Geneva. https://isotc.iso.org/livelink/livelink?func=ll&objId= 4230456&objAction=browse&sort=subtype. [4] CEN BOSS, CEN, Brussels. https://boss.cen.eu/Pages/default.aspx.