Nanoengineering

CHAPTER 3.4

Nanoengineering: A Toolbox of Standards for Health and Safety Brian Haydon CSA Group, Toronto, ON, Canada

Modern microscopy has revealed increased surface area and quantum effects of materials at the nanoscale (i.e., 10
9e10
7 m). Such discovery, referred to as nanotechnology, is providing unique functionalities in materials not commonly associated with the same materials in nonnanoscale size. Research is achieving results to identify, characterize, and exploit these functionalities into reproducible and scalable forms commercialized for economic benefit in modified and new materials, products, and systems. Nanomaterials are derived from common elements and chemicals, and through building material structures and surfaces at the nanoscale. Nanotechnologies is moving forward, for example, to achieve lighter, stronger materials, reduce energy use, and provide less volatile compounds. Often inspired by nature, and through new understanding of the molecular forms of materials, nanotechnologies are bringing breakthroughs and countless applications to benefit society. However, as new and modified materials are developed, health and safety issues need to be carefully assessed, understood, and controlled. Developing standards is one important means to provide guidance, best practices, and requirements for health- and safety-related issues for nanotechnologies. Soon after the millennium, with research into nanoscale materials expanding, a call for standards occurred initiated by forward thinkers from several nations. Since heeding that call and with global cooperation of governments, industry, researchers, consumer interests, and others, collective work has produced over 40 science-based ISO (International Organization for Standardization) and IEC (International Electrotechnical Commission) standards for nanotechnologies. This growing toolbox of standards now exists as a valuable resource for coming decades. ISO and IEC are nongovernmental organizations based in Geneva, Switzerland comprised of over 160 national standard bodies from member countries participating in international technical committees (TCs). These TCs including subset subcommittees and working groups (WGs) develop and publish standards in hundreds of subject areas for ISO and IEC, with the latter specific to electrical/electronic products and systems. ISO and IEC standards are developed by volunteer experts from member countries who Nanoengineering. ISBN 978-0-444-62747-6 http://dx.doi.org/10.1016/B978-0-444-62747-6.00017-8

Copyright © 2015 CSA. Published by Elsevier B.V. All rights reserved.

557

558

Nanoengineering

participate in the drafting of standards. Each member country of ISO and IEC has an obligation for subjects of national interest to: 1. Organize input from relevant interests groups; 2. Contribute expertise to draft standards; 3. Work cooperatively toward consensus; and 4. Vote at significant development milestones. The standards may include content as state-of-the art information, guidance, and best practice as well as content in the form of requirements. Requirements in standards may often be mandated by an authority having jurisdiction (regulator), be specified in buyer/ seller agreements and transactions, be used for conformity assessment of materials and products, or provide rules for management systems. In this chapter, advances in ISO and IEC international standards for nanotechnologies are outlined, with additional facts for Canada, one of many ISO/IEC participating member countries. The intent is to guide the nanotechnology practitioner to useful standards that describe where we stand, what we know, and what can be applied from a standards perspective for nanotechnologies. This is accomplished through overview of select standards recommended as a resource toolbox of technical content and guidance to assist to address health and safety issues for nanotechnologies.

1. WHY STANDARDS FOR NANOTECHNOLOGIES MATTER Standards in general provide rules, test methods, specifications, and best practices that are used every day by suppliers, producers, and regulators. Conformity of products and processes, best practices for incorporating safety concepts into manufacturing, quality assurance, support for trade, and overarching management systems are all documented via standards. A standard can be defined as follows, A document, established by consensus and approved by a recognized body, which provides for common and repeated use, rules, guidelines or characteristics for activities or their results aimed at achieving the optimum degree of order in a given context. Note: Standards should be based on the consolidated results of science, technology and experience and aimed at the promotion of optimum community benefits [1].

Without standards there can be a lack of consistency among practice and requirements. ISO and IEC have provided means for multiple-country input to develop science-based standards for over a century. Such globally based standards assist to ensure that products and services are consistent, compatible, effective, and safe. Standards help to define the many products, processes, and systems we encounter every day. In emerging fields like nanotechnology they will assist to: 1. Define benchmark safety requirements; 2. Provide a framework to design and deliver products more economically;

Nanoengineering: A Toolbox of Standards for Health and Safety

3. Efficiently bring order, quality, know-how, and predictability into the marketplace; 4. Help open doors to markets and facilitate trade around the world; and 5. Serve as a foundation for regulations. The promise of nanotechnologies for technical breakthroughs is being realized, perhaps in more incremental steps than anticipated, but definitely moving forward. The need to understand and manage risks to health and safety in standards have been commonly identified in many assessments and surveys of nanotechnologies. For example, in 2009, CSA Group (Canadian Standards Association), a global-based standardssolutions provider, conducted a needs assessment survey of nanotech industry in Canada [2]. The results highlighted Canadian industry priorities for standards development, surveying trends in nanotechnology-related research, and steps toward commercialization. The results assisted to guide Canadian stakeholders to reaffirm their path forward in standards for nanotechnologies, and to validate Canada’s continued participation in international work at ISO and IEC. Provided as examples, the priorities for standards for nanotechnologies from this Canada-specific survey were as follows: 1. Need for common language (terminology and nomenclature); 2. Support for measurement; 3. Mitigate public concerns about implications for health and the environment a. Workplace safety (for the worker) b. Need for a risk evaluation framework c. Toxicity/hazard potential d. Protection of the environment e. Product safety (for the user); and 4. Enable trade by simplifying import/export [2]. Similar assessments have been completed around the world by associations, governments, and NGOs (nongovernmental organizations). The outputs of these surveys frequently form the basis for road maps, to plan current and future direction for standards. Such priorities have been the basis for the scopes of ISO/TC229, IEC/TC113 and their WGs. Periodic update surveys of standards needs continue to identify new priorities and reassess the relevance of continuing business plans and road maps. For example, in 2013, an ISO/TC229 Study Group on Nanotechnology and Biological Systems has been formed to scope out potential future needs for standards in this emerging subject area. But first some background on the forming of the ISO and IEC TCs for nanotechnologies.

2. ISO/TC229 AND IEC/TC113 ISO/TC229, Nanotechnologies, a TC of ISO, was formed with member country support to develop standards concurrent with global research and commercialization. This proactive approach versus developing standards after commercialization began

559

560

Nanoengineering

with 14 countries meeting in London, United Kingdom in November 2005. That country’s leadership was approved by participating delegates to carry the role of Chair and Secretariat for this new ISO TC. Country membership has grown in subsequent years with 35 participating member countries and 13 observer member countries as of the 17th meeting of ISO/TC229 in November 2014, held at New Delhi, India. ISO/TC229 Nanotechnologies facilitates the development of standards for the safe and responsible use of nanotechnologies. IEC/TC113, Nanotechnology standardization for electrical and electronic products and systems, a TC of IEC, was formed a year later with its first meeting in Frankfurt, Germany, to additionally develop nanotechnology standards for electrical and electronic products and systems. Formal liaison between these two TCs was established to ensure that overlap was minimized and cooperation occurred from the start. Each TC’s subject activities have been divided into WGs. With this, each WG, in accordance with ISO/IEC Directives, has a designated country to convene its activities. In each WG, work items are initiated following an ISO/IEC process toward end documents, which include technical reports, technical specifications (TSs), and international standards following a TC-directed business plan. Refer to ISO/IEC Directives for an overview of the standards development process followed [3]. TC leadership (Chair and Secretariat) and WG convenorship by country for ISO/ TC229 and IEC/TC113 is shown here as of 2014: ISO and IEC Technical Committees (TCs) for Nanotechnology Standards: ISO/TC229, Nanotechnologies

Chair: United Kingdom

Secretariat: United Kingdom

IEC/TC113, Nanotechnology standardization for electrical and electronic products and systems

Chair: United States

Secretariat: Germany Working Groups (WGs) of ISO/TC229 and IEC/TC113

JWG1 Terminology and nomenclature

ISO/TC229 and IEC/ TC113

Convenor: Canada

JWG2 Measurement and characterization

ISO/TC229 and IEC/ TC113

Convenor: Japan

WG3 Health, safety, and environment

ISO/TC229

Convenor: United States

WG4 Material specifications

ISO/TC229

Convenor: China

WG3 Performance assessment

IEC/TC113

Convenor: Germany/Japan

WG7 Reliability

IEC/TC113

Convenor: Japan/Republic of Korea

Nanoengineering: A Toolbox of Standards for Health and Safety

ISO/TC229 has the following objectives, through international standards development, to: 1. Support the sustainable and responsible development of nanotechnologies; 2. Facilitate global trade in nanotechnology-enabled products and systems; 3. Improve quality, safety, security, consumer and environmental protection, together with the rational use of natural resources; and 4. Promote good practice in the production, use, and disposal of nanomaterials and nano-enabled products [4]. The scope of ISO/TC229 is as follows: Standardization in the field of nanotechnologies that includes either or both of the following: Understanding and control of matter and processes at the nanoscale, typically, but not exclusively, below 100 nanometres in one or more dimensions where the onset of size-dependent phenomena usually enables novel applications, Utilizing the properties of nanoscale materials that differ from the properties of individual atoms, molecules, and bulk matter, to create improved materials, devices, and systems that exploit these new properties. Specific tasks include developing standards for: terminology and nomenclature; metrology and instrumentation, including specifications for reference materials; test methodologies; modeling and simulation; and science-based health, safety, and environmental practices [5].

The scope of IEC/TC113 is as follows: Standardization of the technologies relevant to electrical and electronic products and systems in the field of nanotechnology in close cooperation with other committees of IEC and ISO TC 229 [6].

3. THE ROLE OF STANDARDS IN REGULATIONS Standards are often confused with regulations. To assist with understanding the difference, a regulation can be defined as follows: A government/jurisdiction imposed requirement, which specifies product, process or service characteristics with which compliance is mandatory in an applicable jurisdiction. Their applicability is based on the jurisdiction that enacts them. Regulations may be statutes of law, and be applied within the jurisdiction that use them, for example municipal, provincial or federal [1].

It should be noted that ISO and IEC being standards development organizations (SDOs), do not regulate or legislate. ISO and IEC are nongovernmental organizations with no legal authority to enforce implementation of their standards. Nonetheless, a percentage of ISO and IEC standards including ones concerned with health and safety, are often adopted in countries as part of regulatory frameworks, or may be referred to as technical foundation. Such adoptions into regulation are sovereign decisions by regulators or governments of the countries concerned.

561

562

Nanoengineering

Although ISO and IEC do not develop regulations, many national regulatory bodies do participate in standards work for nanotechnologies recognizing their complimentary purpose. The development of standards for nanotechnologies is next described for background and to assist in understanding the types of ISO and IEC standards and their value.

4. THE ISO AND IEC STANDARDS PROCESS ISO and IEC, in general, provide means for multiple-country input to develop sciencebased standards, guidance, and best practices. The ISO/TC229 and IEC/TC113 TCs for nanotechnologies have developed three types of standards, specifically: 1. Informative Technical Reports (TR) indicated as, for example, data obtained from a survey carried out among national bodies, data on work carried out in other international organizations, or data on the “state-of-the-art” in relation to standards of national bodies on a particular subject) [3], 2. Technical Specifications (TS) for a subject “still under development” [3] as a new subject evolves; and 3. International Standards (IS) containing primarily normative requirements. This progression in standards types fits well with the evolving nature of nanotechnologies, as it moves from research-specific science-based content including guidance and best practice, to facets of commercialization where requirements will become more dominant. Other more mature disciplines and product sectors may bypass this progression and proceed to international standards first. For ISO/TC229, Nanotechnologies, technical reports have frequently served as starting points to establish and improve understanding of current knowledge and best practice. A technical report can be useful to scope out work and often may lead to one or a suite of TSs. Similarly, a TS may progress to an international standard in future editions. Note that ISO and IEC processes for these standards types may include systematic review at defined intervals to ensure that the documents keep pace with technology, and are either updated or withdrawn. Monitoring revisions of standards and being aware of new standards are important exercises for which most scientists and engineers are quite familiar. As well, ensuring market relevance is important for ISO and IEC standards, to enable global trade and economic benefit from nanotechnologies. Formal liaison processes are available so that cross-communication with other ISO/IEC TCs that are more product-specific can occur. Designated point persons approved in established liaisons between TCs may have access to working drafts and may participate in meetings and share information. Liaisons are many for ISO/TC229, for example, with ISO/TC 6 Paper, board and pulps, and ISO/REMCO Committee on reference materials and similarly for

Nanoengineering: A Toolbox of Standards for Health and Safety

IEC/TC113, for example, liaison with IEC/TC47 Semiconductor Devices and IEC/TC119 Printed Electronics. Externals liaisons exist too, including ISO/TC229 with OECD-WPMN (Organisation for Economic Co-operation and DevelopmentdWorking Party on Manufactured Nanomaterials), with BIPM (Bureau International des Poids et Mesures), with IUPAC (International Union of Pure and Applied Chemistry), with EC-JRC (European Commission-Joint Research Center), and with the ANF (Asia Nano Forum), to name just a few. Another important part of the process is that ISO and IEC standards, when published, are available for adoption in ISO and IEC member countries. Each country’s national standards system determines the applicability of such documents with the process to follow modeled on ISO/IEC international Directives. As an example, in Canada selective standards for nanotechnologies are being adopted following a national standards body accredited process. The Standards Council of Canada (SCC) is the national standards body in Canada, with multiple SDOs formally accredited to adopt ISO and IEC standards as National Standards of Canada. The first ISO standard for nanotechnologies adopted in Canada, CSA Z12885-12, was published in 2012 through CSA Group [7]. CSA Z12885-12 is titled NanotechnologiesdExposure control program for engineered nanomaterials in occupational settings and provides guidance for the safe use of nanomaterials in the workplace. Based on international ISO/TR 12885 NanotechnologiesdHealth and safety practices in occupational settings relevant to nanotechnologies [8] published in 2008, this standard includes information on nanotechnologies including characterization, health effects, exposure assessments, and control practices plus added guidance for Canadian practices for health and safety management in the workplace. Referring to it can assist companies, researchers, workers, and others to address health and safety during handling, processing, use, and disposal of manufactured nanomaterials. This advice is broadly applicable across a range of nanomaterials and applications. More detail on this standard is provided in section 5.3. Similar to this first-adopted nanotechnology standard, other ISO and IEC standards are being considered for adoption to meet Canadian needs for safe use of nanotechnologies and to support commercialization. In general, in-country adoption of standards is encouraged by ISO and IEC. It is, to an extent, a final step in a country’s commitment as an ISO or IEC member, being somewhat an endorsement of the standard by representative in-country stakeholders for national implementation. In the European Union other means also exist to develop standards separately and publish ISO and IEC standards on a regional basis, for example, CEN and CENELEC standards respectively, with applicability to all EU countries. If an ISO or IEC standard is adopted as a CEN or CENELEC standard, national adoption is obligatory for EU national members.

563

564

Nanoengineering

Alternately, some other countries may not carry through to national adoption and instead may refer to selected international ISO or IEC standards directly where there is value to do so. For nanotechnology standards, some countries may be taking a wait-and-see approach before in-country adopting of select standards, recognizing the evolving and expanding science for this subject area. Such countries may consider national adoption later, for example, when an ISO TS may be further updated and subjected to additional review steps to become a full International Standard. One must refer to a country’s national standards body for the process followed for adoption and use of ISO and IEC standards, and for country or region-specific practices.

5. ISO AND IEC STANDARDS FOR NANOTECHNOLOGIESdTOOLBOX SPECIFICS FOR HEALTH AND SAFETY With background and the standards process explained, highlights of select ISO/IEC standards for nanotechnologies are next presented in order by WG subject. For each WG an overview is provided along with the WG’s relevancy to health and safety issues in nanotechnologies.

5.1 Standards for Terminology and Nomenclature JWG1, Terminology and Nomenclature, of ISO/TC229 and IEC/TC113 have developed a base of terminology for effective communications and common language for testing, classification work, toxicity analysis, health studies, and for enabling trade. A joint ISO/IEC 80004 NanotechnologiesdVocabulary series has been systematically developed to provide basic and complex language for the field of nanotechnologies. As of 2014, over 400 science-based terms and definitions for nanotechnologies have been defined for direct use and as a base for descriptors for other purposes, for example, regulatory needs. The multiple parts in the ISO/IEC 80004 Nanotechnology vocabulary series of standards are listed here, each providing terms published and under development with definitions specific to the indicated subject: TS 80004-1 Part 1: Core terms TS 80004-2 Part 2: Nano-objects TS 80004-3 Part 3: Carbon nano-objects TS 80004-4 Part 4: Nanostructured materials TS 80004-5 Part 5: Nano/bio interface TS 80004-6 Part 6: Nano-object characterization TS 80004-7 Part 7: Diagnostics and therapeutics for healthcare TS 80004-8 Part 8: Nanomanufacturing processes Being developed: Nano-enabled electrotechnical products and systems Being developed: Nanolayer, nanocoating, nanofilm and related terms

Nanoengineering: A Toolbox of Standards for Health and Safety

Being developed: Quantum phenomena in nanotechnology Being developed: Graphene and other 2-D materials [9]. The terms and definitions in this vocabulary series are subject to a systematic review process. New terms and revisions will occur as science and new understanding of nanotechnologies evolves. Some parts in the series provide general terms with horizontal application over multiple sectors, for example, core terms, nanomanufacturing processes, etc., while other parts focus on specific materials emerging as priorities in research and commercialization, like carbon nano-objects (for carbon nanotubes), nanofilms, graphene, and anticipated future topics, for example, cellulosic nanomaterials. Other vocabulary parts may be added at the direction of ISO/IEC member countries. The work of JWG1 includes open communication with JWG2 and WG3 experts of ISO/TC229 to assist toward common language for characterization of nanomaterials for example, what and how to measure nanomaterials, and for health and safety, for example, risk assessment. Reaching consensus among international JWG1 terminology experts has been a challenge. At the start, some nanotechnology-related terms were already in general use, for example, “nanotechnology” and “nanoparticle.” As well, some areas were at their infancy as to common global understanding. To assist with these development challenges, a terminology framework technical report, ISO/TR 12802 NanotechnologiesdModel taxonomic framework for use in developing vocabulariesdCore concepts was developed first by JWG1 [10]. A recommendation from this report was to maintain a hierarchical relationship among primary core terms for nanotechnologies. This was followed as subsequent key vocabularies (terms and definitions) were developed by JWG1. The collaborative work of JWG1, in addition to member countries providing experts, relied on additional input through liaison with internal bodies (liaisons with other ISO TCs) and external bodies (organizations beyond the ISO/IEC committee structure). With many vocabulary parts published, and with intent to promote the use of common terms in the joint ISO/IEC 80004 NanotechnologiesdVocabulary series, these are readily accessed as individual vocabulary parts, or as individual terms and definitions, via the ISO Online Browsing Platform at https://www.iso.org/obp/ui/. Once there, select “Terms and definitions” and enter the term to retrieve its full ISO/ IEC definition [11]. Highlights of health and safety relevant vocabulary parts in the ISO/IEC 80004 NanotechnologiesdVocabulary series are presented next in overview. For TS 80004-1 NanotechnologiesdVocabularydPart 1: Core terms, a hierarchy for the core term “nanomaterial” is followed as in Figure 1. This hierarchy and others expand to multiple terms and their definitions to support a common science-based language for use by researchers, producers, government, users, and others. The fundamental terms in ISO/TS 80004-1 Part 1dCore terms describe major concepts and properties at the nanoscale. The core terms including “nanoscience,” “nanotechnology,” and “nanomaterial,” and associated terms are downward

565

566

Nanoengineering

Nanomaterial

Nano-object Any external dimension in the nanoscale

Nanostructured material Internal or surface structure in the nanoscale

Figure 1 Hierarchy of terms for “nanomaterial” from ISO/TS 80004-1 [12].

applicable to specialized fields. These have seen growing use in research papers, related documents, and associated standards. Such are complimented by terms and definitions for product and specialty areas drawn from terms defined in other ISO and IEC TCs, as well as terms provided by other standards developers, for example, BSI Group (formerly British Standards Institution), ASTM International (formerly American Society for Testing and Materials), and IEEE (Institute of Electrical and Electronics Engineers). In JWG1 work, transparency in meaning for multiple languages is strived for. Overall, progress has been good; however, globally accepted common language for nanotechnologies is still a lofty goal, as for any science-based discipline. An amendment round for Part 1 in 2014 informatively states that health and safety considerations for nanomaterials may be influenced by a complex interplay of nanomaterial parameters. Such information is further expanded upon in standards developed under WG3 of ISO/TC229. Part 2 of the vocabulary series, TS 80004-2 NanotechnologiesdPart 2: Nano-objects [9] replaces ISO/TS 27687 [13]. This earlier version, ISO/TS 27687 was published in 2008 prior to the forming of the ISO/IEC TS 80004 vocabulary series. It provides basic terminology applicable to “nano-objects.” The term “nano-object” stems from the need for a means to describe a nanomaterial as a physically discrete entity in its primary, nonaggregated form, typically at or below 100 nanometers (nm). A one, two, and three external dimension categorization for subset terms under nano-objects shown in Figure 2 was formulated by JWG1 experts in 2006 soon after the forming of ISO/ TC229. Other nano-object-related terms are found in ISO/TS 27687 [13] and have been carried and added to the new ISO/TS 80004-2. This includes terms like “agglomerate” and “aggregate,” both common in other product sectors, but defined as to applicability in nanotechnologies with use and relevance in health and safety assessments. As well, the equivalent relationship of the term “nanoparticle” and “ultrafine particle” is documented.

Nanoengineering: A Toolbox of Standards for Health and Safety

Nano-object One or more external dimensions in the nanoscale

NanoparƟcle

Nanofibre

Nanoplate

Three external dimensions in the nanoscale

Two external dimensions in the nanoscale

One external dimension in the nanoscale

Nanorod Solid nanofibre

Nanotube Hollow nanofibre

Nanowire Electrically conducƟng nanofibre

Figure 2 Hierarchy of terms for “nano-object” from ISO/TS 27687 [13].

With carbon nanotubes, a prominent material for research and commercialization, terms specific to “carbon” nano-objects are defined in TS 80004-3 Nanotechnologiesd VocabularydPart 3: Carbon nano-objects, first published in 2010 [14]. Part 3 provides definitions for terms including single-wall and multiwall carbon nanotubes as well as other dimensional forms of carbon nano-objects, for example, “carbon nanoribbon.” Continuing to Part 4, TS 80004-4 titled NanotechnologiesdVocabularydPart 4: Nanostructured materials [15] covers nanomaterial regions and surfaces at the nanoscale, defined with relevant subcategories including nanostructured powders, nanocomposites, solid nanofoam, nanoporous material, and fluid nanodispersions. There are two other important parts in the ISO/IEC 80004 vocabulary series that integrally support health and safety topics in nanotechnologies. First, TS 80004-6 NanotechnologiesdVocabularydPart 6: Nano-object characterization [16], which engaged global interests from both JWG1 Terminology and Nomenclature and JWG2 Measurement and Characterization WGs. Shared expertise produced over 80 terms and definitions for common metrics, methods of measurement, descriptors, and instrumentation that are often applied to characterize nanomaterials. This includes terms related to measurands for size and shape, scattering techniques, aerosol characterization, separation techniques,

567

568

Nanoengineering

Table 1 Alphabetical list of main current techniques for nano-object characterization [16] Property Current main techniques

Size

Atomic force microscopy (AFM), centrifugal liquid sedimentation (CLS), differential mobility analyzing system (DMAS), dynamic light scattering (DLS), scanning electron microscopy (SEM), particle tracking analysis (PTA), transmission electron microscopy (TEM)

Shape

Atomic force microscopy (AFM), scanning electron microscopy (SEM), transmission electron microscopy (TEM)

Surface area

Brunauer–Emmett–Teller (BET) method

“Surface” chemistry

Secondary ion mass spectrometry (SIMS), X-ray photoelectron spectroscopy (XPS)

Chemistry of the “bulk” sample

Inductively coupled plasma mass spectrometry (ICP-MS), nuclear magnetic resonance spectroscopy (NMR)

Charge in suspensions

Zeta potential

microscopy, surface area measurement, chemical analysis, measurement of mass, crystallinity, and charge measurement in suspensions. Many new tools and instrumentation have made nanotechnologies possible, allowing discovery and characterization of materials at the nanoscale. Table 1 provides an alphabetic list of main current techniques for nano-object characterization. The techniques listed here are not intended to be exhaustive. Common terms and definitions in ISO/TS 80004-6 Nanotechnologiesd VocabularydPart 6: Nano-object characterization assist with effective comparability among laboratories and support reliable exchange of information. Those involved in characterizing nanomaterials may extend beyond materials scientists, biologists, chemists, or physicists, and include regulators and toxicologists. Conclusions reached in risk management for health and safety depends on reproducible, traceable measurements communicated using globally accepted terms and well-documented measurement methods. The reader is encouraged to seek out and use the terminology provided in the ISO/TS 80004-6 vocabulary standard. The second important ISO/IEC vocabulary part in the series to mention is TS 80004-8 NanotechnologiesdVocabularydPart 8: Nanomanufacturing processes [17]. In Part 8: ‘Nanomanufacturing’ is defined as the intentional synthesis, generation or control of nanomaterials, or fabrication steps in the nanoscale for commercial purpose applied to produce nanoobjects or nanostructured materials. [17]

For health and safety, the process can be important to understand the means to produce a nanomaterial, and to build information on potential hazards, if any, in relation to similar processes.

Nanoengineering: A Toolbox of Standards for Health and Safety

As further introduction in Part 8, the TS 80004-8 states that Advancing nanotechnology from the laboratory into volume production ultimately requires careful study of manufacturing process issues including product design, reliability and quality, process design and control, shop floor operations, supply chain management, workplace safety and health practices during production, use, and handling of nanomaterials. Nanomanufacturing encompasses directed self-assembly and assembly techniques, synthetic methodologies, and fabrication such as lithography and biological processes. Nanomanufacturing also includes bottom-up directed assembly, top-down high resolution processing, molecular systems engineering, and hierarchical integration with larger scale systems [17].

Terms defined in NanotechnologiesdVocabularydPart 8, are grouped under direct assembly, self-assembly and synthesis. The latter is categorized based on the phase, gas, liquid, or solid for both physical and chemical methods. Fabrication processes are also defined including those related to lithography, deposition, etching, printing, and coating. Listed processes may not be exclusive to the nanoscale and may result in material features at larger scales. Understanding the process can assist in health and safety analysis, and for comparison with processes already widely used. Then, focus on the nano-enabled aspect can assist to identify underlying differences that may require further evaluation. Hence access to TS 80004-8 NanotechnologiesdVocabularydPart 8: Nanomanufacturing processes, for the terms and definitions therein, is another valuable resource for health and safety reviews and understanding of processes and methods used in nanotechnologies.

5.2 Standards for Measurement and Characterization The development of standards by JWG2 from ISO/TC229 and IEC/TC113 for measurement and characterization considers methods, metrology, and reference materials to support industry and commerce, and provides methods that may support assessment of toxicity and hazards. As outlined in the previous section, in the summary of TS 80004-6 NanotechnologiesdVocabularydPart 6: Nano-object characterization [16] many methods exist (Table 1) and are the subject of research to provide methods for measurement of significant nanomaterial parameters. For JWG2’s first wave of method-specific standards, eight TSs for single-wall carbon nanotubes have been published. Others JWG2 measurement method TSs have followed, for example, methods specific to multiwall carbon nanotubes, gold nanoparticles, quantum dots, and nanoscale powders. Each typically provides sections with detail on measurement principles, sample preparation, procedures, data analysis, interpretation and reporting of results, often with informative illustrated case studies. Some identify measurement uncertainties, which must be considered for reliable and reproducible characterization.

569

570

Nanoengineering

Additionally, a series of questions is routinely asked before new work item proposals (new standards to develop) are accepted into the JWG2-ISO/TC229 work portfolio and when completed drafts are reviewed. For multiple measurands typically necessary to characterize a nanomaterial, this includes but is not limited to, questions (simplified) as follows: • Can the nanomaterial being measured be clearly described? • Is the measurand unnecessarily restrictive? • Is the measurand clearly described? • Is the measurand operationally or method-defined or is it an intrinsic property? • Is the measurement unit defined and are tools for metrological traceability available? • Has the method been validated in one or more laboratories? • Are quality control tools available to demonstrate a laboratory’s proficiency with the test method? • Have the results for the measurement method been published in peer-reviewed journals by several laboratories? • Is the instrumentation required to perform the test widely available; and • Is there a proposed level of measurement uncertainty? [18] The many robust standards from JWG2 that work to address these questions provide a growing resource of documents on measurement, instrumentation methods, and best practices. Such can provide critical base information on material characterization that can guide health and safety assessments in nanotechnologies. This leads us to the next working group of ISO/TC229 which is WG3 Health, Safety and Environmental Aspects of Nanotechnologies.

5.3 Standards for Health, Safety and Environmental Aspects of Nanotechnologies Research in nanotechnologies seeks to isolate and control properties and process for desired function in new and modified products, often referred to as nano-enabled and nano-enhanced products. Functional boundaries for properties are often delineated by material classification, sequence of processes, and specification limits for relevant parameters. Similar classification and limits for nanomaterials, along with understanding their handling and processing may assist toward identifying and quantifying toxicity, addressing safety in the workplace, and setting acceptable boundaries to protect human health. This combined with understanding of the risk of exposure through a product’s life cycle forms a basis for risk management with appropriate controls for health, safety, and the environment. This applies from material synthesis, component fabrication, assembly, and material, component, or product use by an intermediary or consumer, through to end of product life including disposal. For example, hazards may exist for the scientist in the lab and for the worker in the factory. Both are workplaces where risk needs to be assessed and managed. There may be

Nanoengineering: A Toolbox of Standards for Health and Safety

unknowns and partial unknowns for nanomaterials. Similarly, environmental fate of materials, from raw materials processing, intermediate components to products and disposal along this chain, needs to be assessed and managed. In responsible circles, a precautionary approach for workplace safety is being followed. WG3 of ISO/TC229, titled Health, Safety and Environmental Aspects of Nanotechnologies has a road map to provide general health, safety and environmental standards as well as standard methods for nanomaterials. Thirteen standards from WG3-ISO/TC229 have been published as of 2014. Select standards from WG3 are highlighted following, each being important toolbox resources to refer to and apply. First, as introduced earlier, ISO/TR 12885 NanotechnologiesdHealth and safety practices in occupational settings relevant to nanotechnologies [8] provides comprehensive guidance on health and safety for use of nanomaterials in the workplace. It is one of the first completed standards from WG3 of ISO/TC229, published in 2008. As one country’s experience, Canada has adopted this standard as CSA Z12885dNanotechnologiesdExposure control program for engineered nanomaterials in occupational settings [7] and added content on health and safety management specific to occupational health and safety (OHS) practices in Canada. At time of adoption by Canada, the collected resource information and best practices in ISO/TR 12885 was reviewed by an in-Canada committee with representation by research, producer, user, labor and general interests. Being a technical report with informative content only, a normative supplement for Canada was added to: 1. Reinforce the precautionary principle; 2. Follow the familiar Plan-Do-Check-Act model of CAN/CSA-Z1000 Occupational health and safety management1 [19]; and 3. Additionally addresses training requirements and worker engagement. This standard in either form, as an ISO Technical Report or as a CSA Standard, is an essential resource that introduces the unique properties and fabrication methods for nanomaterials. Highlighted are carbon nanotubes, nanoscale oxides and metals, quantum dots, organic polymeric nanomaterials, and bioinspired nanomaterials. A hazard characterization section outlines health and safety dangers and how these may apply to these same nanomaterials. Risk of exposure is covered, with reference to both scientific and practical methods of assessment. Action on risk assessment may be taken through well-explained control methodologies including means to augment risk factors through preventative practices, monitoring of health and stewardship. The risk evaluation process is covered in more detail in another technical report from WG3 of ISO/TC229, ISO/TR 13121 NanotechnologiesdNanomaterial risk evaluation

1

Similar management standards and OHS practices may be applicable in other countries.

571

572

Nanoengineering

[20]. Advances in science and technology are often a balance between risk and reward. Whether referring to impact on the human health, the environment or unsustainable resources, technology must balance both positive and negative traits. ISO/TR13121 describes a process for nanomaterial risk evaluation in an adaptable framework for use regardless of operational scale, for risk analysis of nanomaterials through the supply chain from raw material procurement, processing, assembly, product use, to end-of-life disposal. Steps are provided to evaluate risks and then assess risk management options including steps to decide, document, act, review, and adapt. Annexes include health hazard, environment hazard/fate data sets, life cycle properties, and exposure profiles or physical and chemical properties, a tiered testing approach, health and environmental hazard data, an output worksheet, and other reference material. The Technical Report is based on the Nano-Risk Framework, an approach created by the United States Environmental Defense Fund and DuPont [21]. As overview, a first step in risk evaluation describes the material, for example, its chemical composition, physical structure and form, concentration, solubility, and aggregation and agglomeration state. With this, material source, material manufacture, product fabrication, and packaging must be reviewed for the intended use, including maintenance and reuse, and end of life, with consideration of recycling and waste management. Questions are provided in ISO/TR 13121 to assist in the evaluation with three sets of “profiles” created. Information is collected for data sets on the: 1. Nanomaterial’s physical and chemical properties; 2. Inherent environmental, health, and safety (EHS) hazards; and 3. Potential human and environmental exposures throughout the nanomaterial’s life cycle [20]. Missing data, variations in properties, anticipated changes across the life cycle, and relevance of hazard endpoints to specific routes of exposure are addressed. An output worksheet provides a means for the collection, evaluation, management, and communication of data in the risk evaluation process. Evaluation steps include review of the hazard and exposure profiles, application of uncertainty factors, assessing the potential for, and consequences of, changes in material and applications, and the need to identify knowledge gaps. Real data or reasonable worstcase scenarios are planned means to fill data sets to move to the next step, assess risk management options. A case-by-case approach is recommended with a performance-based level of risk management. The hierarchy sited as guidance from “most effective to least effective” controls is the following: 1. Elimination, substitution, or reduction of the material, process, or condition that presents the hazard; 2. Engineering controls;

Nanoengineering: A Toolbox of Standards for Health and Safety

3. Warnings; 4. Training, procedural, and administrative controls; and 5. Personal protective equipment [20]. A decide, document and act phase, followed by a review and adapting step completes the assessment. The organization is recommended to include regular and as-needed reviews “to ensure that the information, evaluations, decisions, and actions regarding manufactured nanomaterials are kept up-to-date. These reviews could be integrated into an organization’s existing processes such as the ‘management review’ step in ISO 9001 or 14001” [20]. Overall, the risk evaluation framework for manufactured nanomaterials found in ISO/TR 13121 is a valuable resource. In Canada, this same guidance-based technical report from ISO has been adopted as a National Standard of Canada, designated as CAN/CSA ISO/TR13121 NanotechnologiesdNanomaterial risk evaluation [22]. Another document from WG3 of ISO/TC229 is ISO/TR 13014 Nanotechnologiesd Guidance on physicochemical characterization of engineered nanoscale material for toxicological assessment [23]. It provides guidance on critical characteristics for nanomaterials at all stages of life cycle to assist in assessing and interpreting the toxicological effect of manufactured nano-objects. The four steps of the risk assessment process are explained, which includes the following: 1. Hazard identification; 2. Doseeresponse assessment; 3. Exposure assessment; and 4. Risk characterization. The most relevant physicochemical characteristics are identified in three groups: 1. Physical, including parameters for particle size and particle size distribution, aggregation/agglomeration state, shape, and surface area; 2. Composition and surface chemistry; and 3. Interaction influences including surface charge, solubility, and dispersibility [23]. Potential problems are covered including confounding and variations in batch-tobatch formulations. For each physicochemical characterization a descriptor, clarification, relevance, measurand, examples of methods, and examples of current standards are presented. Measurement uncertainty is explained specific to nano-objects. Reference to ISO/TR 13014 NanotechnologiesdGuidance on physico-chemical characterization of engineered nanoscale material for toxicological assessment [23] can be a useful resource for detailed nanomaterial characterizations. Next, ISO/TR 13329 NanomaterialsdPreparation of material safety data sheet (MSDS) [24] also from WG3 provides guidance for preparation of safety data sheets (SDS) for manufactured nanomaterials. Note that MSDSs are transitioning to SDSs under the new GHS (Globally Harmonized System of Classification and Labeling of Chemicals) being implemented in many countries (http://www.ccohs.ca/products/posters/msds/).

573

574

Nanoengineering

Communication of workplace health and safety information is fundamental to health and safety measures for handling and use of chemicals. The report recommends to prepare an SDS for all manufactured nanomaterials unless testing or assessment have indicated that the nanomaterial is nonhazardous, or that it is not likely that there can be release or exposure of the nanomaterial, or that certain identified cut-off levels are met. This is guidance criteria only that may be superseded by legislated protocols. Hazard identification in SDSs needs to be clear and in conformance to the GHS. This technical report assists in understanding and means toward providing relevant entries of information on SDSs. Other related information is provided, for example, guidance on mixtures. As well, the high-reactivity of some nanomaterial forms, particularly powders that have fire, explosion, or catalytic reaction hazards are described as an alert to include on the SDS where applicable. In informative annexes in ISO/TR 13329 there are sample measurement methods and reference standards linked to specific measurement parameters considered relevant to toxicological testing, for example, particle size, aggregation/agglomeration state, shape, surface area, composition, surface chemistry, surface charge, and dispersibility. The reader is reminded that ISO standards are subject to update thus the listed parameters and references in the Annex are not inclusive. Two additional TSs from WG3 of ISO/TC229 build upon specific aspects of ISO/ TR 12885 discussed earlier. First, ISO/TS 12901-1 NanotechnologiesdOccupational risk management applied to engineered nanomaterialsdPart 1: Principles and approaches [25] was published in 2012 providing expanded guidance for risk management in occupational settings. Like its predecessor, it provides a brief overview of common nanomaterials including fullerenes, carbon nanotubes, nanowires, quantum dots, nanoscale metals and metal oxides, carbon black, dendrimers, and nanoclays. Potential health issues for nanomaterials with risk for of inhalation, dermal exposure, or ingestion are outlined. Referral to in-country requirements for use of chemicals or hazardous substances is emphasized. An eight-step risk management framework based on United Kingdom regulations has been adapted to nanomaterials, for potential use in other countries and jurisdictions. The adapted steps first validate competency of those involved in the assessment. This is followed by information collection, health risk evaluation including fire or explosion risk, determining control measures, informing and educating workers, evaluation of controls, health surveillance, and spillage, accidental release, disposal procedures and prevention of fire and explosion. Evaluation of controls includes a comprehensive list of instruments for direct and indirect measurement of number (of particles), mass, and surface area concentration, along with sampling strategies and limitations. For information, control approaches are provided in an annex with a table with entries for several types of nanomaterials, with numeric guidance from current literature as to the effectiveness of controls including enclosure, LEV (local exhaust ventilation) and

Nanoengineering: A Toolbox of Standards for Health and Safety

fume hoods. The challenge of establishing OELs (occupational exposure limits) for nanomaterials is discussed with case study examples provided. A benchmark levels approach is presented with default to the precautionary approach for situations for missing product information. The second TS in the occupational risk management series from WG3 is ISO/TS 12901-2 NanotechnologiesdOccupational risk management applied to engineered nanomaterialsd Part 2: Use of the control banding approach [26]. Recognizing that specific OELs for nanomaterials may still be in the distant future, control banding is presented, in this TS published in 2014, as one approach to controlling workplace exposure for nano-objects, their agglomerates and aggregates. For note, the materials combination of a nano-object, their agglomerates and aggregates, is referred to by the acronym NOAA in this and other ISO/TC229 standards. Control banding for use with nanomaterials has been adapted from its use in the pharmaceutical industry as a means to work more safely with chemicals with limited or no toxicity information available. Control banding is intended to complement traditional quantitative methods, grouping hazard and exposure risk into bands from which recommended control measures may be derived for application to workplace safety, as well as workplace maintenance and cleaning operations with potential for contact with nanomaterials. A review and adapt step completes the process to ensure new information is properly assessed and adjustments are made for continual improvement. The use of the control banding may require trial application to specific nanomaterials. As well, minor modification of the methods may be required to comply with national requirements. However, such guidance can assist with risk management in occupational settings for workplace health and safety. Hence ISO/TS 12901-2 Part 2: Use of the control banding approach [26] is another important resource document for the nanotechnology practitioner. For information to the reader, establishing OELs for nanomaterials is the subject of a new project, an approved work item (AWI) of ISO/TC229-WG3 designated as ISO/AWI TR 18637 General framework for the development of OELs for nano-objects and their aggregates and agglomerates [27]. This will be a first ISO/TC229 technical report on this subject. This ground-breaking work is engaging global experts to scope out needs and capability toward determining such limits, if achievable, for nanomaterials. This will build on starting efforts by select countries and industry interests to establish such limits. There are other standards from WG3 of ISO/TC229, in accordance with the WG3 road map plan that have been published and are in the process of development to further address relevant health, safety, and environmental aspects of nanotechnologies. Methods for assessing the toxicity of some nanomaterials are still at early stages of development, with progress being made in other forums as well, for example, in global regulatory activities by the OECD to validate testing protocols for nanomaterials.

575

576

Nanoengineering

5.4 Standards for Material Specifications Standards from WG4, Material Specifications of ISO/TC229 specify relevant characteristics of engineered nanomaterials to facilitate communication between buyers and sellers of nanomaterials. A first standard from WG4 is ISO/TS 12805 Nanotechnologiesd Materials specificationsdGuidance on specifying nano-objects [28]. It presents a thorough system of specifications and measurements to improve the communication of nanoobject design and performance. The intent of the information for material characteristics in this TS is to assist to the following: 1. Avoid inadequate information that may influence performance and/or process; 2. Ensure that correct measurement method is used; and 3. Ensure that the measurement technique is correctly applied [28]. Batch-to-batch or lot-to-lot consistency is a goal with guidance provided on characteristics that might have influenced on product performance and downstream processing. Measurement methods are proposed divided between those more appropriate for production environments versus more costly, less-frequent assessments using more specialized equipment, for example, scanning probe microscopy. Guidance on specifying the EHS characteristics of manufactured nano-objects is outside the scope of this TS. However, the characteristics measured and methods used may be useful to understand practical measurement techniques that can be applied in a production environment, and possibly in the design lab. As well, a comprehensive table of measurement methods for use in routine quality control in industrial environments is included in an informative appendix.

5.5 Standards for Performance Assessment and ReliabilitydIEC/TC113 IEC/TC113 Nanotechnology standardization for electrical and electronic products and systems complements the activities of ISO/TC229, Nanotechnologies and forms an integral part of global standards development for nanotechnologies. JWG1 and JWG2 are joint WGs between ISO/TC229 and IEC/TC113, with each TC serving as lead on specific standards development projects. WG3, Performance Assessment, specific to IEC/TC113 considers market demand and technology pull with an emphasis on fabrication, processing, and process control. Standards following the IEC/TC113 business plan are intended to address all stages in the life cycle of electrotechnical products enabled by nanotechnology with focus on products whose performance is inherently related to the use of nanomaterials and nanoprocesses. WG7, Reliability, also specific to IEC/TC113, has the following scope: To develop standards for the assessment of reliability in the field of nano electrotechnology. Focus is on failure mechanisms and failure modes related to the use of nanomaterials, material interfaces and nanoscale contacts with consideration to size dependent

Nanoengineering: A Toolbox of Standards for Health and Safety

effects. Standards to be developed include test methods to identify failure mechanisms, determine lifetime, analyze failure effects and estimate durability of nano-enabled products [6].

Examples of IEC/TC113 product sectors include nano-enabled batteries, photovoltaic cells, nanoscale electronics, and lighting devices, such as LEDs. It is recommended that if in-depth data is required for such devices that standards from IEC/TC113 be scanned for measurement techniques and specifications for related nanomaterials and nano-enabled components, products, and systems.

6. WHAT IS EXPECTED FOR THE FUTURE? Recalling the standards needs survey of nanotech industry in Canada, the priorities were as follows: 1. Need for common language (terminology and nomenclature) 2. Support for measurement 3. Mitigate public concerns about implications for health and the environment a. Workplace safety (for the worker) b. Need for a risk evaluation framework c. Toxicity/hazard potential d. Protection of the environment e. Product safety (for the user) 4. Enable trade by simplifying import/export [2]. Each of these easily map to the plans and delivered standards, from the WGs of ISO/ TC229 and IEC/TC113. With many standards published, progress is clearly being made to fulfill these priorities. It is not suggested that the work is done, but a strong foundation of standards for nanotechnologies now exists. Other activities that may be of interest to the nanotechnology practitioner are the Task Groups of ISO/TC229, specifically the Nanotechnologies and Sustainability Task Group and the Consumer and Societal Dimensions Task Group. These work hand-in-hand with the ISO/TC229 WGs to assist to ensure that communication and awareness of sustainability, consumer and societal issues are considered during the development of standards. Like the volunteer national experts of the WGs, participants on ISO and IEC task groups are voluntary experts from ISO and IEC member countries. In general, persons involved in nanotechnologies are encouraged to become involved in ISO and IEC standards work. This can support your current and future goals, providing networking opportunities with like-minded experts from around the world to share and expand your knowledge of nanotechnologies. In summary, standards work for nanotechnologies continues concurrently with research and commercialization. Since standards are “living” documents they are subject to revision to keep pace with science and technology, including

577

578

Nanoengineering

requirements and best practices for health and safety. New work items for standards will be initiated to complete road maps and respond to new priorities; for example, the previously mentioned ISO/TC229 Study Group for Nanotechnology and Biological Systems. Continuing research and progress in commercialization will fill gaps, generate needs in standards, and assist to resolve health and safety issues. Nanotechnologies supported by standards will advance responsible and sustainable global trade in nano-enhanced and nano-enabled products and systems.

7. SOURCES FOR FURTHER INFORMATION NanoengineeringdA Recommended Toolbox of Standards for Health and Safety The following toolbox of standards will support and assist in understanding for research, health and safety issues, and commercialization for nanotechnologies. For terminology the ISO/IEC 80004 nanotechnology vocabulary series provides terms and definitions. A recommended sampling of parts in this series for common language and better communications includes the following: 1. ISO/TS 80004-1 Part 1: Core terms 2. ISO/TS 80004-2 Part 2: Nano-objects 3. ISO/TS 80004-4 Part 4: Nanostructured materials 4. ISO/TS 80004-6 Part 6: Nano-object characterization 5. ISO/TS 80004-8 Part 8: Nanomanufacturing processes. Individual terms and their definitions from the ISO/IEC 80004 series above can be accessed on the ISO Online Browsing Platform at https://www.iso.org/obp/ui/, select “Terms and definitions” and enter the term [11]. Recommended health and safety standards for nanotechnologies include: 6. CSA Z12885 NanotechnologiesdExposure control program for engineered nanomaterials in occupational settings, or ISO/TR 12885 Nanotechnologiesd Health and safety practices in occupational settings relevant to nanotechnologies 7. CAN/CSA ISO/TR 13121 NanotechnologiesdNanomaterial risk evaluation or ISO/TR 13121, NanotechnologiesdNanomaterial risk evaluation 8. ISO/TR 13329 NanomaterialsdPreparation of material safety data sheet (MSDS) 9. ISO/TS 12901-1 NanotechnologiesdOccupational risk management applied to engineered nanomaterialsdPart 1: Principles and approaches 10. ISO/TS 12901-2 NanotechnologiesdOccupational risk management applied to engineered nanomaterialsdPart 2: Use of the control banding approach Another useful reference standard for material specification is:

Nanoengineering: A Toolbox of Standards for Health and Safety

11. ISO/TS 12805 NanotechnologiesdMaterials SpecificationsdGuidance on specifying nano-objects. Many other ISO/IEC nanotechnologies standards are available but have not been listed for sake of brevity. Refer to the Internet-accessible lists to seek out other standards that may be of interest for your field. This may include, in addition the recommended toolbox, standards for measurement and characterization of nanomaterials from JWG2, guidance on labeling of consumer products from ISO/ TC229-WG3, nomenclature (a naming system plan for nanomaterials) from JWG1, and other valuable ISO/TC229 WG3 EHS standards on related topics, with more to be published. As well, if you are a subject matter specialist, consider becoming a volunteer ISO or IEC expert and participate directly in standards development through your national standards body. In conclusion, for a list of ISO/TC229, Nanotechnologies, standards, Internet search on keyword “ISO/TC229,” select “ISO/TC229” then “Work programme.” Then check “Published standards” or “Standards under development.” For a list of IEC/TC113, Nanotechnology standardization for electrical and electronic products and systems standards, Internet search on keyword “IEC/TC113” select “IEC/TC113,” then select “Projects/Publications.”

REFERENCES Permission to reproduce [3], [4], [5] [6], [12] [13], [16] [17], [18] [20], [23], and [28] was provided by SCC. No further reproduction is permitted without prior written approval from SCC. [1] Standards Council of Canada. Program Requirements for the Accreditation of Standards Development Organizations and for the Approval of National Standards of Canada. 2012. p. 14. CAN-P-1. [2] Haydon B. Nanotechnologies Industry Trends and Priorities in Canada for Standards Development. CSA Group 2009:8. [3] International Organization for Standardization. ISO/IEC Directives, Part 1, Consolidated ISO SupplementdProcedures Specific to ISO. 5th ed. 2014. http://www.iso.org/directives. [4] International Organization for Standardization. ISO/TC229 Business Plan, from http://isotc.iso.org/ livelink/livelink/fetch/2000/2122/687806/ISO_TC_229__Nanotechnologies_.pdf? nodeid¼6507632&vernum¼-2 [retrieved on March 10, 2014]. [5] International Organization for Standardization. ISO/TC229 front pageeScope, from http://www. iso.org/iso/iso_technical_committee?commid¼381983 [retrieved on March 10, 2014]. [6] International Electrotechnical Commission. IEC/TC113, from http://www.iec.ch/dyn/www/f? p¼103:7:0::::FSP_ORG_ID,FSP_LANG_ID:1315,25 [retrieved on August 12, 2014]. [7] CSA Z12885-12. NanotechnologieseExposure control program for engineered nanomaterials in occupational settings. [8] ISO/TR 12885. NanotechnologiesdHealth and safety practices in occupational settings relevant to nanotechnologies. 2008. [9] International Organization for Standardization. ISO/TC229 pagedWork programme, from http:// www.iso.org/iso/home/store/catalogue_tc/home/store/catalogue_tc/catalogue_tc_browse.htm? commid¼381983&published¼on&development¼on [retrieved on March 10, 2014]. [10] ISO/TR 12802:2010, NanotechnologiesdModel taxonomic framework for use in developing vocabulariesdCore concepts.

579

580

Nanoengineering

[11] ISO Online Browsing Platform. Terms and Definitions, from https://www.iso.org/obp/ui/ [retrieved on March 10, 2014]. [12] ISO/TS 80004e1:2010, NanotechnologiesdVocabularydPart 1: Core terms, Figure 1-Nanomaterial framework. [13] ISO/TS 27687:2008, NanotechnologiesdTerminology and definitions for nanoobjectsdNanoparticle, nanofibre and nanoplate, Figure 2, Fragment of hierarchy of terms related to nano-objects. [14] ISO/TS 80004e3:2010, NanotechnologiesdVocabularydPart 3: Carbon nano-objects. [15] ISO/TS 80004e4:2011, NanotechnologiesdVocabularydPart 4: Nanostructured materials. [16] ISO/TS 80004e6:2013, NanotechnologiesdVocabularydPart 6: Nano-object characterization, Table 1. [17] ISO/TS 80004e8:2013, NanotechnologiesdVocabularydPart 8: Nanomanufacturing processes. [18] ISO/TC229dIEC/TC113/JWG2 Metrological check-list for use in preparation and evaluation of ISO NWIPs and ISO WDs, ISO/TC 229 N 673, 2010. [19] CAN/CSA-Z1000-06 (R2011) Occupational health and safety management. [20] ISO/TR 13121:2011 NanotechnologiesdNanomaterial risk evaluation. [21] Nano-Risk Framework. An approach created by the Environmental Defense Fund and DuPont, For further detail, see http://www.nanoriskframework.org. [22] CAN/CSA-ISO/TR13121:2013 NanotechnologiesdNanomaterial risk evaluation. [23] ISO/TR 13014:2013 NanotechnologiesdGuidance on physico-chemical characterization of engineered nanoscale material for toxicological assessment. [24] ISO/TR 13329:2012 NanomaterialsdPreparation of material safety data sheet (MSDS). [25] ISO/TS 12901e1:2012, NanotechnologiesdOccupational risk management applied to engineered nanomaterialsdPart 1: Principles and approaches. [26] ISO/TS 12901e2:2014 NanotechnologiesdOccupational risk management applied to engineered nanomaterialsdPart 2: Use of the control banding approach. [27] ISO/AWI TR 18637. General framework for the development of occupational exposure limits for nano-objects and their aggregates and agglomeratesdunder development. [28] ISO/TS 12805:2011 NanotechnologiesdMaterials specificationsdGuidance on specifying nanoobjects.