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For the promotion of global trading and the reduction of potential risks, the role of international standardization of nanotechnologies has become more and more important. This book gives an overview of the current status of nanotechnology including the importance of metrology and characterization at the nanoscale, international standardization of nanotechnology, and industrial innovation of nano-enabled products.
First the field of nanometrology, nanomaterial standardization and nanomaterial innovation is introduced. Second, major concepts in analytical measurements are given in order to provide a basis for the reliable and reproducible characterization of nanomaterials. The role of standards organizations are presented and finally, an overview of risk management and the commercial impact of metrology and standardization for industrial innovations.

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Contents

Cover

Series Page

Title Page

Copyright

Dedication

Series Editor Preface

About the Series Editor

Foreword

Preface

Contents of this Book

Chapter 1: Introduction: An Overview of Nanotechnolgy and Nanomaterial Standardization and Opportunities and Challenges

1.1 Standards and Standardization

1.2 Nanotechnology Standardization

1.3 Nanomaterial Standardization

1.4 Challenges

1.5 Opportunities

1.6 Summary

Part One: Nanotechnology Basics: Definitions, Synthesis, and Properties

Chapter 2: Nanotechnology Definitions at ISO and ASTM International: Origin, Usage, and Relationship to Nomenclature and Regulatory and Metrology Activities

2.1 Introduction

2.2 Context based on Size, Property, and Regulatory Framework

2.3 Nano-objects: Particles, Shapes, and Shape Descriptors

2.4 Collections of Nano-Objects

2.5 Layers and Coatings as Surface Chemistry

2.6 National Definitions

2.7 Nomenclature

2.8 Terminology as a Controlled Vocabulary and Nomenclature as Knowledge Organization

2.9 Concluding Remarks

Acknowledgments

References

Chapter 3: Engineered Nanomaterials: a Discussion of the Major Categories of Nanomaterials

3.1 Description of Nanotechnology and Nanomaterials

3.2 Nanomaterials' Morphologies

3.3 Types of Nanomaterials

3.4 Properties of Nanomaterials

3.5 Applications of Nanomaterials and Nanocomposites

3.6 Conclusions and Outlook

References

Chapter 4: Nanomaterials Synthesis Methods

4.1 Classification

4.2 Physical Methods

4.3 Chemical Methods

4.4 Mechanical Methods

4.5 Biological Synthesis

4.6 Summary

References

Chapter 5: Physicochemical Properties of Engineered Nanomaterials

5.1 Introduction

5.2 Composition

5.3 Size and Size Distribution

5.4 Morphology and Shape

5.5 Aggregation and Agglomeration

5.6 Surface Properties

5.7 Conclusions and Outlook

References

Chapter 6: Biological Properties of Engineered Nanomaterials

6.1 Introduction

6.2 Biological Properties of ENMs

6.3 Metrology and Standardization of ENMs in the Context of Biological Properties

6.4 Conclusions

References

Part Two: Metrology for Engineered Nanomaterials

Chapter 7: Characterization of Nanomaterials

7.1 Introduction

7.2 Size

7.3 Shape

7.4 Surface

7.5 Solubility

7.6 International Standards and Standardization

7.7 Summary

Acknowledgments

References

Chapter 8: Principal Metrics and Instrumentation for Characterization of Engineered Nanomaterials

8.1 Introduction

8.2 ENM Metrics and Instrumentation for Characterization

8.3 Summary

List of Abbreviations

Disclaimer

References

Chapter 9: Analytical Measurements of Nanoparticles in Challenging and Complex Environments

9.1 Introduction

9.2 Nanoparticle Measurements in Soils and Sediments

9.3 Nanoparticle Measurements in Air

9.4 Nanoparticle Measurements in Cosmetics

9.5 Nanoparticle Measurements in Aquatic Environments

9.6 Nanoparticle Measurements in Foods

9.7 Nanoparticle Measurements in Biological Matrices

9.8 Key Challenges for Characterizing Nanoparticle Sizes and Shapes in Biological Matrices

9.9 Key Challenges in the Quantitative Measurement of Nanoparticles in Biological Matrices

9.10 Key Challenges for Determining Nanoparticle Dose/Concentration in Biological Matrices

9.11 Key Challenges in Measuring Nanoparticle Agglomeration in Biological Matrices

9.12 Notable Instrumentation for Characterizing Nanoparticles in Biological Matrices

9.13 Concluding Remarks

NIST Disclaimer

List of Acronyms

References

Chapter 10: Metrology for the Dimensional Parameter Study of Nanoparticles

10.1 Introduction

10.2 Traceability of the Dimensional Measurements at the Nanoscale

10.3 Measuring the Nanoparticle Size

10.4 Conclusions

References

Chapter 11: Analytical Nanoscopic Techniques: Nanoscale Properties

11.1 Introduction

11.2 Historical Overview of Analytical Nanoscopic Techniques

11.3 Scanning Probe Microscopy

11.4 Electron Microscopy

11.5 Emerging Nanocharacterization Techniques

11.6 Summary

References

Chapter 12: Tribological Testing and Standardization at the Micro- and Nanoscale

12.1 Introduction

12.2 A Brief History of Tribology

12.3 Scale Effects in Tribology Testing

12.4 Experimental Methods for Tribology Characterization

12.5 International Standardization in Micro- and Nanotechnology

Acknowledgments

References

Chapter 13: Stochastic Aspects of Sizing Nanoparticles

13.1 Introduction

References

Part Three: Nanotechnology Standards

Chapter 14: ISO Technical Committee 229 Nanotechnologies

14.1 Introduction

14.2 ISO/TC 229 Nanotechnologies

References

Chapter 15: Standards from ASTM International Technical Committee E56 on Nanotechnology

15.1 Introduction

15.2 ASTM International

15.3 ASTM Technical Committee E56

15.4 ASTM E56 Standards

15.5 ASTM E56 Future Technical Focus Areas

15.6 Summary

References

Chapter 16: International Electrotechnical Commission: Nanotechnology Standards

16.1 International Electrotechnical Commission

16.2 IEC Technical Committee 113

16.3 Summary, Conclusions, and Future Focus Areas

References

Chapter 17: Standardization of Nanomaterials: Methods and Protocols

17.1 Genesis of CEN/TC 352

17.2 Nanostrand: a European Road Map of Standards Needs for Nanotechnologies

17.3 Mandate for a European Standardization Program for Nanotechnologies

17.4 Mandate for Developing European Standards for Nanotechnologies

17.5 Publication and Ongoing Work of CEN/TC 352

References

Chapter 18: Nanomaterial Recommendations from the International Union of Pure and Applied Chemistry

18.1 IUPAC Organization

18.2 The Future of IUPAC in Nanotechnology

18.3 Summary, Conclusions, and Future Focus Areas

References

Chapter 19: Reference Nanomaterials to Improve the Reliability of Nanoscale Measurements

19.1 Introduction

19.2 Reference Materials for Quality Control

19.3 Reference Materials for Instrument Calibration

19.4 Reference Materials for Method Validation

19.5 Outlook/Future Trends

19.6 Conclusions

Acknowledgment

References

Chapter 20: Versailles Project on Advanced Materials and Standards (VAMAS) and its Role in Nanotechnology Standardization

20.1 Background

20.2 How Does VAMAS Help?

20.3 The VAMAS Role in Nanotechnology

20.4 Summary

Part Four: Risk-Related Aspects of Engineered Nanomaterials

Chapter 21: Categorization of Engineered Nanomaterials For Regulatory Decision-Making

21.1 Introduction

21.2 Chemical Categories

21.3 Adoption of a Similar Approach for Nanomaterials

21.4 Categorization in a North American Regulatory Context

21.5 Physicochemical Properties

21.6 Conclusion

References

Chapter 22: Nano-Exposure Science: How Does Exposure to Engineered Nanomaterials Happen?

22.1 Introduction

22.2 The Stages of a Product's Lifecycle

22.3 Product Life Evaluation

22.4 Product Lifecycle versus Product Value Chain

22.5 Exposure at Each Stage of the ENM Product Lifecycle

22.6 Environmental Release of Engineered Nanomaterials from Common Nano-enabled Products

22.7 Conclusions

References

Chapter 23: Nanotoxicology: Role of Physical and Chemical Characterization and Related In Vitro, In Vivo, and In Silico Methods

23.1 Importance of Toxicological Studies – Interaction of Nanoparticles and Living Species

23.2 Regulatory Aspects Applied to Nanomaterials

23.3 Essential Chemical and Physical Characterization for Nanotoxicological Studies

23.4 Methods in Nanotoxicology

23.5 Conclusions

References

Chapter 24: Minimizing Risk: An Overview of Risk Assessment and Risk Management of Nanomaterials

24.1 How Risk Assessment and Risk Management Can Minimize Risk

24.2 Risk Assessment of Nanomaterials

24.3 Risk Management of Nanomaterials

24.4 Conclusions

References

Part Five: Nanotechnology-based Products, Applications, and Industry

Chapter 25: Nanoenabled Products: Categories, Manufacture, and Applications

25.1 General Overview

25.2 Case Studies: Composite Systems

25.3 Case Studies: Nanoporous Systems

25.4 Case Studies: Particle-Based Systems

25.5 Summary and Outlook

References

Chapter 26: Application of Nanomaterials to Industry: How are Nanomaterials Used and What Drives Future Applications?

26.1 Introduction

26.2 Nanomaterial Application Types

26.3 Sources of Innovation for Nanomaterials

26.4 Barriers for Implementation

26.5 Applications

26.6 Conclusions

References

Chapter 27: Ethics and Nanomaterials Industrial Production

27.1 Current Situation

27.2 Strategy

27.3 Safety

27.4 Data Generation and Expertise Implementation

27.5 Transparency

27.6 Conclusions

List of Acronyms

References

Chapter 28: Nanomaterials for Energy Applications

28.1 Introduction

28.2 Photovoltaics

28.3 Solid-State Lighting

28.4 Fuel Cell

28.5 Biomass

28.6 Electrochemical Batteries

28.7 Electrochemical Capacitors

28.8 Hydrogen Storage

28.9 Conclusions

References

Chapter 29: The Importance of Metrology and Standardization of Nanomaterials for Food Industry and Regulatory Authorities in Europe

29.1 Introduction

29.2 Current Trends in the Use of Engineered Nanomaterials in Agri/Food/Feed Products

29.3 Nanometrology in Agri/Food/Feed

29.4 Regulatory Aspects Relating to Standardization and Safe Use of Nanomaterials

29.5 Safety Data for Regulatory Authorization in Europe

29.6 Current Status of Regultory Assessments in Europe

29.7 Concluding Remarks

References

Chapter 30: Magnetic Properties and Applications of Engineered Nanomaterials

30.1 Introduction

30.2 Fundamentals of Nanomagnetism

30.3 Applications of Nanomagnets

30.4 Summary

References

Chapter 31: Nanomaterials in Textiles

31.1 Introduction

31.2 Manufacturing Processes

31.3 Quality Assurance/Quality Control

31.4 Applications

31.5 Conclusions

References

Index

End User License Agreement

List of Tables

Table 2.1

Table 2.2

Table 2.3

Table 2.4

Table 2.5

Table 2.6

Table 2.7

Table 2.8

Table 3.1

Table 3.2

Table 3.3

Table 3.4

Table 3.5

Table 3.6

Table 3.7

Table 3.8

Table 4.1

Table 4.2

Table 4.3

Table 4.4

Table 8.1

Table 8.2

Table 8.3

Table 11.1

Table 11.2

Table 12.1

Table 15.1

Table 15.2

Table 16.1

Table 16.2

Table 20.1

Table 22.1

Table 24.1

Table 24.2

Table 24.3

Table 25.1

Table 25.2

Table 25.3

Table 26.1

Table 26.2

Table 26.3

Table 26.4

Table 29.1

Table 31.1

Table 31.2

List of Illustrations

Figure 2.1

Figure 2.2

Figure 3.1

Figure 3.2

Figure 3.3

Figure 3.4

Figure 3.5

Figure 3.6

Figure 3.7

Figure 3.8

Figure 4.1

Figure 4.2

Figure 4.3

Figure 4.4

Figure 4.5

Figure 4.6

Figure 4.7

Figure 4.8

Figure 4.9

Figure 4.10

Figure 4.11

Figure 4.12

Figure 4.13

Figure 4.14

Figure 5.1

Figure 5.2

Figure 5.3

Figure 6.1

Figure 6.2

Figure 6.3

Figure 6.4

Figure 7.1

Figure 8.1

Figure 8.2

Figure 9.1

Figure 10.1

Figure 10.2

Figure 10.3

Figure 10.4

Figure 10.5

Figure 11.1

Figure 11.2

Figure 11.3

Figure 11.4

Figure 11.5

Figure 11.6

Figure 11.7

Figure 12.1

Figure 12.2

Figure 12.3

Figure 12.4

Figure 12.5

Figure 12.6

Figure 12.7

Figure 12.8

Figure 12.9

Figure 12.10

Figure 13.1

Figure 13.2

Figure 13.3

Figure 13.4

Figure 13.5

Figure 13.6

Figure 15.1

Figure 15.2

Figure 16.1

Figure 16.2

Figure 19.1

Figure 19.2

Figure 19.3

Figure 19.4

Figure 21.1

Figure 21.2

Figure 21.3

Figure 22.1

Figure 22.2

Figure 22.3

Figure 23.1

Figure 23.2

Figure 23.3

Figure 23.5

Figure 23.4

Figure 23.6

Figure 23.7

Figure 25.1

Figure 25.2

Figure 25.3

Figure 25.4

Figure 25.5

Figure 25.6

Figure 25.7

Figure 25.8

Figure 25.9

Figure 25.10

Figure 25.11

Figure 25.12

Figure 25.13

Figure 25.14

Figure 26.1

Figure 26.2

Figure 26.3

Figure 27.1

Figure 27.2

Figure 27.3

Figure 27.4

Figure 27.5

Figure 28.1

Figure 28.2

Figure 28.3

Figure 30.1

Figure 30.2

Figure 30.3

Figure 30.4

Figure 30.5

Figure 30.6

Figure 30.7

Figure 30.8

Figure 30.9

Figure 30.10

Figure 30.11

Figure 31.1

Figure 31.2

Figure 31.3

Figure 31.4

Figure 31.5

Figure 31.6

Guide

Cover

Table of Contents

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Further Volumes of the Series “Nanotechnology Innovation & Applications”

Axelos, M. A. V. and Van de Voorde, M. (eds.)

Nanotechnology in Agriculture and Food Science

2017

Print ISBN: 9783527339891

Cornier, J., Kwade, A., Owen, A., Van de Voorde, M. (eds.)

Pharmaceutical Nanotechnology

Innovation and Production

2017

Print ISBN: 9783527340545

Fermon, C. and Van de Voorde, M. (eds.)

Nanomagnetism

Applications and Perspectives

2017

Print ISBN: 9783527339853

Meyrueis, P., Sakoda, K., Van de Voorde, M. (eds.)

Micro- and Nanophotonic Technologies

2017

Print ISBN: 9783527340378

Müller, B. and Van de Voorde, M. (eds.)

Nanoscience and Nanotechnology for Human Health

2017

Print ISBN: 9783527338603

Puers, R., Baldi, L., van Nooten, S. E., Van de Voorde, M. (eds.)

Nanoelectronics

Materials, Devices, Applications

2017

Print ISBN: 9783527340538

Raj, B., Van de Voorde, M., Mahajan, Y. (eds.)

Nanotechnology for Energy Sustainability

2017

Print ISBN: 9783527340149

Sels, B. and Van de Voorde, M. (eds.)

Nanotechnology in Catalysis

Applications in the Chemical Industry, Energy Development, and Environment Protection

2017

Print ISBN: 9783527339143

Edited by Elisabeth Mansfield, Debra L. Kaiser, Daisuke Fujita, and Marcel Van de Voorde

Metrology and Standardization for Nanotechnology

Protocols and Industrial Innovations

All books published by Wiley-VCH are carefully produced. Nevertheless, authors, editors, and publisher do not warrant the information contained in these books, including this book, to be free of errors. Readers are advised to keep in mind that statements, data, illustrations, procedural details or other items may inadvertently be inaccurate.

Library of Congress Card No.: applied for

British Library Cataloguing-in-Publication DataA catalogue record for this book is available from the British Library.

Bibliographic information published by the Deutsche NationalbibliothekThe Deutsche Nationalbibliothek lists this publication in the Deutsche Nationalbibliografie; detailed bibliographic data are available on the Internet at http://dnb.d-nb.de.

© 2017 Wiley-VCH Verlag GmbH & Co. KGaA, Boschstr. 12, 69469 Weinheim, Germany

All rights reserved (including those of translation into other languages). No part of this book may be reproduced in any form - by photoprinting, microfilm, or any other means - nor transmitted or translated into a machine language without written permission from the publishers. Registered names, trademarks, etc. used in this book, even when not specifically marked as such, are not to be considered unprotected by law.

Print ISBN: 978-3-527-34039-2ePDF ISBN: 978-3-527-80005-6ePub ISBN: 978-3-527-80029-2Mobi ISBN: 978-3-527-69998-8oBook ISBN: 978-3-527-80030-8

Thanks to my wife for her patience with me spending many hours working on the book series through the nights and over weekends. The assistance of my son Marc Philip related to the complex and large computer files with many sophisticated scientific figures is also greatly appreciated.

Marcel Van de Voorde

Series Editor Preface

Since years, nanoscience and nanotechnology have become particularly an important technology areas worldwide. As a result, there are many universities that offer courses as well as degrees in nanotechnology. Many governments including European institutions and research agencies have vast nanotechnology programmes and many companies file nanotechnology-related patents to protect their innovations. In short, nanoscience is a hot topic!

Nanoscience started in the physics field with electronics as a forerunner, quickly followed by the chemical and pharmacy industries. Today, nanotechnology finds interests in all branches of research and industry worldwide. In addition, governments and consumers are also keen to follow the developments, particularly from a safety and security point of view.

This books series fills the gap between books that are available on various specific topics and the encyclopedias on nanoscience. This well-selected series of books consists of volumes that are all edited by experts in the field from all over the world and assemble top-class contributions. The topical scope of the book is broad, ranging from nanoelectronics and nanocatalysis to nanometrology. Common to all the books in the series is that they represent top-notch research and are highly application-oriented, innovative, and relevant for industry. Finally they collect a valuable source of information on safety aspects for governments, consumer agencies and the society.

The titles of the volumes in the series are as follows:

Human-related nanoscience and nanotechnology

Nanoscience and Nanotechnology for Human Health

Pharmaceutical Nanotechnology

Nanotechnology in Agriculture and Food Science

Nanoscience and nanotechnology in information and communication

Nanoelectronics

Micro- and Nanophotonic Technologies

Nanomagnetism: Perspectives and Applications

Nanoscience and nanotechnology in industry

Nanotechnology for Energy Sustainability

Metrology and Standardization of Nanomaterials

Nanotechnology in Catalysis: Applications in the Chemical Industry, Energy Development, and Environmental Protection

The book series appeals to a wide range of readers with backgrounds in physics, chemistry, biology, and medicine, from students at universities to scientists at institutes, in industrial companies and government agencies and ministries.

Ever since nanoscience was introduced many years ago, it has greatly changed our lives – and will continue to do so!

March 2016 Marcel Van de Voorde

About the Series Editor

Marcel Van de Voorde, Prof. Dr. ir. Ing. Dr. h.c., has 40 years' experience in European Research Organisations, including CERN-Geneva and the European Commission, with 10 years at the Max Planck Institute for Metals Research, Stuttgart. For many years, he was involved in research and research strategies, policy, and management, especially in European research institutions.

He has been a member of many Research Councils and Governing Boards of research institutions across Europe, the United States, and Japan. In addition to his Professorship at the University of Technology in Delft, the Netherlands, he holds multiple visiting professorships in Europe and worldwide. He holds a doctor honoris causa and various honorary professorships.

He is a senator of the European Academy for Sciences and Arts, Salzburg, and Fellow of the World Academy for Sciences. He is a member of the Science Council of the French Senate/National Assembly in Paris. He has also provided executive advisory services to presidents, ministers of science policy, rectors of Universities, and CEOs of technology institutions, for example, to the president and CEO of IMEC, Technology Centre in Leuven, Belgium. He is also a Fellow of various scientific societies. He has been honored by the Belgian King and European authorities, for example, he received an award for European merits in Luxemburg given by the former President of the European Commission. He is author of multiple scientific and technical publications and has coedited multiple books, especially in the field of nanoscience and nanotechnology.

Foreword

Nanotechnology metrology and standardization are of growing importance in the era of globalization. Applications of nanotechnologies have accelerated in many countries over the past decade, triggered by the US National Nanotechnology Initiative (NNI) in 2000. Nanotechnologies are a strong driving force in various industries to improve existing products and create new products. Progress in the development of such products requires advanced metrologies because measurements of nano-objects are very challenging. On the other hand, commercialization and global trade of products requires standardization that gives the basis for the dissemination of nanotechnologies to society.

The importance of international standards and standardization activities is continually increasing. Over 160 countries are members of the World Trade Organization (WTO), which established the rules of trade between nations by the agreement on Technical Barriers to Trade (TBT) signed in 1995. Industrial products are spreading worldwide in the era of globalization and many countries around the world now participate actively in efforts to develop international standards. Standardization of nanotechnologies attracted attention in 2004 led by efforts from CEN (European Committee for Standardization), ANSI (American National Standards Institute), and JSA (Japan Standards Association). In 2005–2006, several major standards development organizations (SDOs) established technical committees (TCs) focused on nanotechnology: ISO TC 229, CEN TC 352, ASTM International E56, and IEC (International Electrotechnical Commission) TC 113. The combined efforts of these Committees have produced a large body of standards concerning terminology, physicochemical and biological measurements, and the environmental, health, and safety of nanomaterials and nanotechnologies.

Standardization of nanotechnology has been accelerated not only to promote industrial application of nanotechnology but also to bring about social acceptance of nanotechnology. The importance of the latter aspect becomes prominent by reports that suggest nanomaterials (nano-objects) may be harmful to human health and ecological systems. Reflecting the increasing interest in precautionary actions for the handling of nanomaterials, efforts among the SDOs mentioned above have been aimed at the implementation of future regulations. Some of the efforts have been already implemented as “list of recognized standards” by FDA. It has adopted four nanotechnology standards: two technical specifications of ISO (TS 14101 for surface characterization of gold and TS 8004-6 for vocabulary of nano-object characterization) and two ASTM standards (E2490 for measurement of particle size distribution, and E2535 for handling unbound nanoparticle in occupational setting). Moreover, France has set regulations that requests companies and private and public research laboratories to declare the use (producing, distributing, and importing) of substances at the nanoscale beginning January 1, 2013.

With regard to nanometrology, for example, EC regulation (no. 1907/2006) concerns “substances intentionally produced at nanometric scale, containing particles, in an unbound state or as an aggregate or as an agglomerate and where, for a minimum proportion of particles in the number size distribution, one or more external dimensions is in the size range 1–100 nm.” It is necessary to show the number size distribution of substance in the size range 1–100 nm, even if the substance contains both particles in unbound and bound/fused states. Since it is a rather hard task to precisely analyze such substances with high-resolution measurement techniques applicable to nanoscale objects, current measurement techniques need further improvement. It follows that the development of nanometrology and nanomaterial standards support further improvement of measurement techniques adaptable to nanoscale characterization, leading to both essential progress of nanotechnology and social acceptance of nanotechnology. It is because the first step of measurement can be considered as “the process of quantitatively comparing a variable characteristic, property, or attribute of a substance, object, or system to some norm.” The major targets of nanometrology are, for example, the analysis of dimensional, chemical, mechanical, and electrical properties of thin films and/or nanostructured materials, and also bionano materials. The growing number of journal articles on nanometrology and the growing number of standards clearly suggests that the importance of nanometrology is reaffirmed through the activation of nanotechnology standardization. It is, therefore, necessary to pay great attention to the progress of both nanometrology and nanotechnology standardization, which are described in detail in this excellent book.

Professor and Director of Strategic Innovation Office Nagoya University/Japan Shingo Ichimura

and

Special Emeritus Advisor of National Institute of

Advanced Industrial Science and Technology/Japan

July 2016

Preface

Nanotechnology, first coined as a discipline in 2000, has applications in myriad sectors, including healthcare, energy, and transportation. In this book, engineered nanomaterials are considered to be materials that have been purposely synthesized or manufactured to have at least one external dimension of approximately 1–100 nm and that exhibit unique properties determined by this size. Engineered nanomaterials, also referred to as nanomaterials throughout this book, are increasingly incorporated into consumer products and military goods, referred to as nanotechnology-enabled products or simply products. The development and manufacturing of engineered nanomaterials and products are contingent on trustworthy, validated measurements of nanomaterial properties, and product performance. Such measurements are challenging due to a number of factors, including the small dimensions and surface-dominated behavior of nanomaterials and the need to perform measurements in realistic, complex environments. These and other challenges are present at all life cycle stages, from the production of nanomaterials and manufacture of products to use and disposal or recycling of both nanomaterials and products.

Metrology – the science of measurement – is essential to the development of new instruments and methods to image, characterize, and manipulate nanomaterials, the adaptation of existing methods for large-scale materials and chemicals to nanomaterials, and the interpretation and understanding of all measurements. Standards, including consensus-based documentary standards and reference materials, are required to ensure accurate and reproducible measurements of nanomaterials and products. This book is an informational resource for researchers, developers, manufacturers, and regulators on the state and importance of metrology and standards for nanotechnology and on current and emerging applications of nanotechnology in various sectors.

Contents of this Book

The chapters in this book are organized in six major parts:

Introduction

:

Chapter 1

provides an overview of standards, beginning with a general discussion of the importance of standardization to trade, technology, and innovation. The remainder of the chapter addresses nanotechnology standards, specifically three types of standards-related products: consensus-based documentary standards published by standards development organizations; reference materials and certified reference materials developed by National Metrology Institutes; and prestandards protocols and guidance documents issued by various organizations. Challenges to and opportunities for standards development are also discussed in this part.

Nanotechnology Basics

:

Chapters 2

6

cover topics that are fundamental to nanotechnology and to the remaining chapters in this book. A comprehensive treatise on the challenges and successes in developing a set of nanotechnology-related terms and their definitions that are acceptable to diverse stakeholders is presented in

Chapter 2

. Major categories of nanoscale materials, including engineered nanomaterials, such as metallic nanoparticles, and nanostructured bulk materials, such as nanoporous catalysts, are discussed in

Chapter 3

. Categorization based on dimensionality, composition, and properties are presented, along with examples of applications for each category.

Chapter 4

covers the synthesis of nanoscale materials by physical, chemical, mechanical, and biological methods. The identification and descriptions of key physicochemical properties of engineered nanomaterials that are important to determine prior to the use and application of a nanomaterial are provided in

Chapter 5

. Biological properties of engineered nanomaterials are dependent on physicochemical properties, and

Chapter 6

elucidates the biological properties of engineered nanomaterials in the context of the physiological and pathological pathways encountered by a nanomaterial when it enters the body of a human or animal.

Metrology for Engineered Nanomaterials

: This part of the book consists of seven chapters, ordered from broad coverage of instrumentation and methods for the characterization of engineered nanomaterials to specific methods and properties. Collectively, these chapters demonstrate the state of the art in metrology for engineered nanomaterials. In

Chapter 7

, the author provides a perspective on the challenges and issues to consider in characterizing four key physicochemical aspects of engineered nanomaterials – size, shape, surface, and solubility. A comprehensive discourse on the vast array of instruments and methods for characterizing 10 physicochemical properties of engineered nanomaterials typically considered to be of prime importance, consistent with the four physicochemical aspects highlighted in

Chapter 7

, is presented in

Chapter 8

. The importance of performing measurements in realistic media cannot be overemphasized, and

Chapter 9

is devoted to methods applicable to complex environments such as soil, sediment, and biological matrices.

Chapter 10

focuses on dimensional metrology, covering traceability of dimensional measurements at the nanoscale, applicable methods, instrument calibration, and uncertainty estimation. Microscopes are arguably the most commonly used tools to characterize engineered nanomaterials;

Chapter 11

provides an in-depth tutorial on the principles of five established microscopy-based techniques for nanoscale measurements, as well as four emerging techniques. In

Chapter 10

, the author describes tribological measurements, for example, friction and wear, from the microscale to the nanoscale, including three typical testing instruments and international standardization efforts for such measurements. The final chapter in this part of the book,

Chapter 13

, illustrates stochastic, that is, random element, factors to consider in determining the size of nanoparticles by electron microscopy methods.

Nanotechnology Standards

: In this part of the book, “standards” is taken to include reference materials, consensus-based documentary standards, and prestandardization activities. The eight chapters in this part address ongoing international standardization efforts in nanotechnology. Reference nanomaterials are essential tools to assure accurate and reproducible measurement results from research and development to production.

Chapter 14

highlights the intended uses of reference nanomaterials with illustrated examples. The next three chapters,

Chapters 15

17

, describe the consensus-based standards activities in the three international standards development organizations with dedicated nanotechnology committees: ISO, ASTM International, and IEC. The actions taken to establish a committee and a business plan for European documentary standards in nanotechnology are described in

Chapter 18

. A new effort to develop standard nomenclature for nanomaterials by the International Union of Pure and Applied Chemistry is described in

Chapter 19

. The final chapter in this part of the book concerns prestandardization efforts on nanomaterials in VAMAS, a group of national metrology institutes concerned with developing best practices and standards.

Risk-Related Aspects of Engineered Nanomaterials

: There are many existing and future applications of nanomaterials; however, widespread commercialization of products is constrained by concerns about potential risks of nanomaterials to humans and the environment at all life cycle stages.

Chapter 21

describes various categorization approaches for nanomaterials and their applicability to risk decision-making by regulatory agencies. Risk is most simply defined as the product of exposure times hazard. Exposure scenarios at each nanomaterial product lifecycle stage, with an emphasis on environmental exposure, are presented in

Chapter 22

, along with examples of environmental releases of nanomaterials from four common types of products.

Chapter 23

on nanotoxicology presents an overview of characterization approaches and regulations and describes a new approach combining

in vitro

,

in vivo

, and

in silico

methods to assess nanotoxicology. This part of the book is culminated by

Chapter 24

, a comprehensive discourse on minimizing risk of nanomaterials that provides strategies to support and frameworks for risk assessment and nanomaterial risk management practices to protect workers, consumers, the public, and the environment.

Nanotechnology-Based Products, Applications, and Industry

: The final part of this book concerns the commercialization of nanotechnology.

Chapter 25

provides extensive descriptions of the categories of consumer and industrial nanoenabled products used today, and the manufacturing methods for six major types of such products. This chapter also provides detailed case studies on applications for several of these major types of products.

Chapter 26

describes applications of the most commonly used nanomaterials and issues concerning the commercialization of nanotechnology, including sources of innovation and barriers resulting from uncertainties in nanomaterial properties, regulation, and consumer perspectives. Ethical issues concerning the industrial production of nanomaterials are discussed in

Chapter 27

wherein the authors provide a strategy for addressing these issues. The remaining four chapters in this part of the book cover different application areas: energy (

Chapter 28

), food and food-related industries (

Chapter 29

), magnetics (

Chapter 30

), and textiles (

Chapter 31

).

Collectively, the 31 Chapters in this book encompass a broad range of topics related to metrology and standardization of nanomaterials that are essential to advance nanotechnology innovation and commercialization.

NIST Materials Measurement LaboratoryElisabeth Mansfield

Boulder, CO, USA Debra L. Kaiser

July 2016

1Introduction: An Overview of Nanotechnolgy and Nanomaterial Standardization and Opportunities and Challenges

Ajit Jillavenkatesa

National Institute of Standards and Technology (NIST), U.S. Dept. of Commerce, 100 Bureau Drive, Gaithersburg, MD 20899, USA

1.1 Standards and Standardization

Standards and standards development activities are of increasingly significant interest as these and associated products directly impact trade, technology, innovation, and hence competitiveness. A 1999 OECD (Organization for Economic Cooperation and Development) report on Regulatory Reform and International Standardization1 cites a study that estimated that 80% of trade (estimated to be about $4 trillion annually, at the time of the study) could be affected by standards or associated technical regulations. Given the growth in trade and number of countries that have joined the global trading system since this report appeared, it is clear that the impact of standards and their use as technical regulations have likely grown dramatically, and impacts trillions of dollars annually.

Standards have also national and local positive impacts, and multiple studies point to the benefits accruing from the development and use of standards and standardized approaches. An effort by the International Organization for Standardization (ISO) to compile studies on the economic benefits of standardization2 included studies that showed in the United Kingdom standards made an annual contribution of GBP 2.5 billion to the economy, and 13% of the growth in labor productivity was attributed to standards. More locally, companies that participate in and use standards reap direct benefits from standards. The benefits span a broad spectrum of technologies and organizations and can range from large multinational companies with tens of thousands of employees to small enterprises with 10 to 20 employees.

Standards play a critical role as they represent an agreed-upon approach, and also form the lingua franca that enables clear and precise communication of intent and expectation. Applying this common language in communication and in processes provides predictability in performance and enables interoperability. Standards also reflect consensus among experts and often embody the state of the art in technology. Thus, standards can help achieve public policy objectives such as consideration of health and safety consideration of materials or products, enable technology innovation by providing common platforms upon which competitors and product developers can provide further value-added products and services, and enable interoperability by defining where and how interoperability is needed and desired.

All these directly benefit consumers and users through better products, improved performance, and reduced costs. Evidence of these benefits of standardization is seen in products as mundane as motor oil used to lubricate automotive engines, safety glasses and ladders used by tinkerers and home improvement professionals, and smartphones used by just about everyone. Smartphones represent a rather remarkable story of the success of standardization as they have evolved from large brick-sized (and just as heavy) contraptions capable of making scratchy phone calls that could last only a few minutes to amazingly complex handheld computers with remarkable computing power that have completely transformed every facet of our lives and all in about two decades.

1.2 Nanotechnology Standardization

Standards development in support of nanotechnology has now been underway in a range of international, regional, and national organizations for over 10 years. For a relatively recent activity, the progress made in these organizations is noteworthy. Standards development activities involve the development of documentary standards, measurement protocols, test specifications, and reference materials. Prior to examining the trajectory of nanotechnology standardization, it is important to understand some of the broader trends relating to technology standardization as that can provide some additional context to understand and appreciate nanotechnology standardization.

1.2.1 Technology Standardization

Technology standardization has been underway as an organized activity for centuries. Examples of early technology standardization are seen in guilds and similar collectives in Europe, where the guilds established common practices for measurements and tools among guild members.3 Examples of common measures and tools used to ensure equity in trade are seen in many museums in cities around Europe. Modern day standardization, as we know it, can be considered to have started more than a 100 years ago with the formation of formal groups to help develop common solutions to problems confronting technology deployment. An example of such a formally government-driven and government-organized activity was the convention in 1865 that established the predecessor to today's International Telecommunications Union to address challenges posed in exchange of telegraph traffic and associated tariffs. Another example of stakeholders organizing themselves into groups to address problems of engineering, production procurement through standards was the establishment of the International Association for Testing Materials, which organized working groups to discuss testing methods for iron, steel, and other materials supporting the railroad industry in the United States.4 This group paved the way for the formation of the American Section of the International Association for Testing Materials in 1898, which is the predecessor to today's ASTM International.

Today, technology standards development is underway in many organizations that develop standards and specifications using models that are responsive to the needs of their members or the unique characteristics of the industries that support the standards development. The strong interest in technology-related standardization is driven in large part by an expanded awareness and understanding of the strategic value of standardization. Increased participation in standards development by countries that have not been traditional leaders or major contributors to standards is changing the landscape of standards development in many bodies. Many emerging economies are looking to both lead and actively participate in the development of international standards, by suggesting new ideas for standardization, bringing forward technologies for standardization, and actively supporting the participation of their experts in the development of technology standards. This increased participation is ensuring that standards have greater global relevance and applicability, but in some instances it is also leading to tensions in standards development in light of varying cultural differences and expectations.

1.2.2 Development of Standards for Nanotechnology

Nanotechnology standardization is being driven by a combination of factors that create a push–pull dynamic. As nanotechnology and nanomaterials are increasingly being used in commercial applications, nanotechnology-related standardization is helping by developing common vocabularies and terminologies and by providing standardized testing techniques that can inform important decisions about potential risks relating to these materials. Simultaneously, developments in applying measurement existing techniques to assess materials and properties in the nanoscale range, and the advent of new techniques for measurement, are also informing the development of standards for nanotechnology and nanomaterials.

Though standards development activities in the size range considered to be nanoscale have been underway for many years, standardization specifically for the purpose of elucidating properties of nanomaterials and for enabling nanotechnology can be considered to have started in the early 2000s. This timing also tracks the development of many national initiatives focusing on nanotechnology such as the National Nanotechnology Initiative (NNI) in the United States, which was established in 2000. Two efforts in the development of international standards for nanotechnology and nanomaterials were initiated in 2005. ISO established Technical Committee (TC) 229, or ISO TC229, on nanotechnologies with initial efforts focused on developing standards for terminology and nomenclature, metrology and instrumentation, and environmental, health, and safety (EHS) practices.5 ISO TC229 later expanded its scope of activities to develop standards for material specifications relating to nanomaterials. ASTM International's Committee E56's initial efforts focused largely on standards both for physical, chemical, and toxicological measurements and for safe handling of nanomaterials.6 Later, E56 broadened its efforts to include common file formatting of nanomaterial data and education and workforce training for nanotechnology. In early 2007, the International Electrotechnical Commission (IEC) established Technical Committee 113 to develop standards for “technologies relevant to electronic products and systems in the field of nanotechnology.”7 IEC TC113's initial scope of work included standardization for components and intermediate assemblies made of nanoscale materials, their properties and functionalities, final products that used these components, and standardization in various fields of activities that would see applications of nanotechnology.8 Recognizing the commonality in scope and potential for overlap in work in developing standards for terminology and nomenclature and standards for measurement and characterization, ISO TC229 and IEC TC113 established joint working groups for standardization in these two areas.

The framework of international standards development work established by these technical committees has provided an excellent start in addressing many questions relating to a common and agreed-upon vocabulary for nanotechnology and its applications, metrology and characterization, important EHS-related questions, and materials and device characterization. Some of these standards are now being considered for use by regulators, and some are already being referenced in rules, proposed rules, or other guidance supporting the implementation or regulations, such as those in the European Commission's Recommendation on the Definition of Nanomaterial,9 the Environmental Protection Agency's Proposed Rule on reporting and record keeping requirements for chemical substances when manufactured or processed using nanoscale materials10, or as part of the Food and Drug Administration's Recognized Consensus Standards Program11 and industry.12

Nanotechnology standards development work in ASTM International13 E56 has resulted in 15 standards including test methods for physical and chemical characterization of nanomaterials and in support of EHS aspects of nanotechnology. Recent efforts have led to the establishment of work to address questions arising from the increased commercial availability of nanoenabled consumer products and the publication of standard guides and practices for workforce education. This work is unique in that it addresses an important need for worker training and credentialing.

Standards development activities in ISO TC229 are informed by experts from 36 participating countries and have resulted in nearly 50 products, including standards, technical specifications, and technical reports (as of June 2016).14 These products cover standards for terminology, nomenclature, measurement, characterization, metrology, EHS aspects, and material and product specifications. In addition, work in ISO TC229 has also focused on how consumer, societal, and sustainability aspects could be considered in the development of nanotechnology standards, given the confidence that nanotechnology can help in solutions to address many societal and sustainability challenges. Recently, the group has also been exploring possible standardization opportunities that may lie at the intersection of nanotechnology and biological systems.

IEC TC113 standardization work leverages expertise from 14 participating countries and includes 13 specifications, standards, and technical reports that cover test methods for measurement and characterization of electrical and electronic properties of various nano-objects and specifications to assist in different aspects of nanomanufacturing.15 These do not include terminology- and vocabulary-related standards that are developed in the joint working groups led by ISO TC229.

Governments have actively supported the development of international standards for nanotechnology. In the United States, the President's Council of Advisors on Science and Technology (PCAST) in their most recent (fifth) assessment of the National Nanotechnology Initiative called for continuing US federal agency participation in the development of international standards, particularly relating to EHS, as a necessary element for supporting the commercialization of nanotechnology.16 Similar sentiments acknowledging the important role of international standards and international engagement in the development of measurement tools and solutions were expressed in previous PCAST assessments of the NNI. The fourth PCAST assessment of the NNI (2012) recommended identifying an individual who could coordinate US federal agency efforts relating to nanotechnology standards development.17

The European Commission, through two standardization mandates to the European Standards Organizations (ESOs), has expressed its belief about the importance of standards to meet the Commission's objectives with regard to nanotechnology. The Commission first articulated its approach relating to nanotechnology in 2004 in COM (2004) 338 “Towards a European Strategy for Nanotechnology” and the related strategy document “Nanosciences and Nanotechnologies: An Action Plan for Europe 2005–2009.” To support the objectives laid out in these policy documents, the Commission issued Standardization Mandate M/40918 in 2007 charging the ESOs to undertake a landscape scan of existing nanotechnology-related standards activities, identify the need for new standards, identify other standards-related deliverables, and identify suitable stakeholders who could contribute to the development of such standards. In 2010, the European Commission issued the second nanotechnology-related standardization mandate M/461 that requested the ESOs to develop specific standards “as regards measurement and testing tools for the characterization, behavior of nanomaterials and exposure…”19

1.2.3 Nanotechnology Standards Development in Europe

Nanotechnology-related standardization in Europe is actively underway in a hybrid model. National standards bodies in many European countries have organized national committees for nanotechnology standardization. Many of these national technical committees also act as mirror committees that represent their nation's expertise in the standards development work in the development of international standards such as in ISO and IEC, and in regional standards such as those developed in the European Committee for Standardization, CEN. In addition, these technical committees also develop standards and specifications to address national needs. Examples of such activities include a range of Publicly Available Specifications (PAS) from the British Standards Institute.20 Simultaneously, work is underway in CEN, the lead organization among the ESOs, for standards development work relating to nanotechnology. CEN established Technical Committee 352 in 2006. Similar to the organization of work in ISO TC229, CEN TC352 has a working group each for measurement, characterization, and performance evaluation and for EHS aspects. In addition, CEN TC352 also has a working group to consider commercial and other stakeholder aspects. Due to the established working relationship between ISO and CEN and the ability of national bodies to adopt ISO (or IEC) standards as national standards, many of the standards developed in ISO TC229 have been adopted as European standards21 through CEN processes for regional adoption of standards. In addition, CEN/TC352 also has standards activities underway that are independent of the standardization activities in ISO TC229 and represent regional interest of the stakeholders.

1.2.4 Working with the Organization for Economic Cooperation and Development

Another international organization that is playing an important role in developing protocols and specifications for measurement and characterization of nanomaterials is the Organization for Economic Cooperation and Development's Working Party on Manufactured Nanomaterials (OECD WPMN).22 The work of this group has focused on addressing questions about the safety of manufactured nanomaterials. Though OECD is not a standards developing organization, this OECD group works in collaboration with ISO TC229 and other standards, regulatory, and industry bodies in developing its guidance documents and specifications. Of particular note has been the collaboration between the OECD WPMN and the ISO TC229's Joint Working Group on Measurement and Characterization (JWG2) to accelerate the development of test protocols that are suitable for characterization of specific parameters (endpoints) for 13 manufactured nanomaterials that were identified by OECD WPMN as initial materials of interest. The list contains materials that are either already in mainstream commerce or are expected to be in wide-scale commercial use soon. Parameters of interest include chemical composition, aggregation/agglomeration, particle size distribution, crystalline phase, dustiness, specific surface area, water solubility/dispersability, zeta potential, photocatalytic activity, porosity, redox potential, radical formation potential, crystallite size, and surface chemistry. A report published in early 2016 discusses the techniques used to determine the above properties for the materials of interest.23 Other publications from the group that touch upon nanomaterials can be found at the publication's site for the series on the Safety of Manufactured Nanomaterials.24

1.3 Nanomaterial Standardization

While the discussion so far has focused on documentary standards development activities, it is also important to note work underway relating to the development of physical standards that are very well characterized and commercially available to help users benchmark their measurement or material characterization processes, calibrate equipment, or help establish metrological traceability to a primary standard, such as a primary unit of measurement (SI unit). These materials, generally referred to as reference materials or certified reference materials, are produced typically by national measurement institutes (or national metrology institutes) and are made available with detailed information such as how the material was characterized, the characterized values and the associated uncertainty of those values, instructions for storage and use, and a time frame during which the stated values would be considered reliable.

The National Institute of Standards and Technology (NIST) in the United States has developed (certified) reference materials (trademarked by NIST as (Standard) Reference Materials, RM or SRM) with values specified for specific surface area (titanium dioxide),25 mass fraction of various elements encountered in the analyses of carbon nanotubes,26 and physical/dimensional characterization of nanoparticles (10, 30, and 60 nm gold nanoparticles27 and 2 nm Si nanoparticles28). In addition, NIST experts have also developed reference materials that provide a common set of single-wall carbon nanotube dispersions of varying aspect ratios and purity29 to help with measurement comparisons. The NIST portfolio of reference materials also includes polyvinlylpyrrolidone-coated silver nanoparticles30 that can be used as a benchmarking and investigative tool in the evaluation of potential EHS risks that may be associated with manufactured nanomaterials during their product life cycle.

Germany's Bundesanstalt fur Materialforschung und –prüfung ((BAM) Federal Institute for Materials Research and Testing) has created a range of “nanoscaled reference materials” available as certified reference materials, quality control materials, and reference materials to support reliable characterization of materials and material properties in the nanoscale. The attributes covered by these materials include flatness, film thickness, step heights, lateral dimensions, critical dimensions (e.g., pitch, surface topography, etc.), pore depth, particle size (including standards to characterize contaminants on surfaces), crystal size, and other attributes.31

The development of these materials takes significant lead time and effort. While these materials might be issued by one organization, the development of these materials, including sourcing of the raw materials and validation of testing methods, requires collaborations with many other organizations. Significant effort is spent in developing a suitable sampling scheme to ensure all samples of the material are statistically similar to each other and the values assigned to the material would apply to any sample, within the limits of the associated uncertainty.

1.4 Challenges

There are several challenges confronting nanotechnology standards development, despite the robust network of organizations that are helping develop nanotechnology standards and a healthy body of standards-related activities. While many of these challenges are similar to those encountered in the early stages of standardization of any technology, there are other challenges that are unique to nanotechnology standardization and are also magnified due to the broad interest in nanotechnology, due to the large resource investment in these technologies by both governments and private sector, and due to the initial excitement about of the benefits of nanotechnology.

1.4.1 Data and Information Gaps

Technology standardization inherently depends on robust data and knowledge that often represents, and is derived from, the state of science within that technology. In well-established technology areas, there is an existing body of work and commonly agreed-upon scientific practices and processes that help generate data which in turn forms the basis for standardization work. Consequently, the standards enable further uniformity in generating new data. This virtuous cycle enables technology development and innovation in a somewhat incremental manner.

One of the biggest hurdles confronting experts developing nanotechnology standards is that much of the data and information needed for standards development such as for physical and chemical characterization, or for evaluating toxicological effects, are still being developed. Further confounding the issue is that there are a large number of material systems that are of both academic and commercial interests. While some material systems display similarities in properties and lend themselves to classification, other material systems are remarkably different and have to be dealt with separately. While teams around the world are actively generating and contributing data, the validation of the data and confidence in the techniques used to generate this data form a critical step before the data can be used for standardization.

The interplay between material systems and techniques is particularly vexing as measurement characterization techniques that have traditionally been used at the macroscale often do not readily lend themselves for use with nanomaterials and so may have to be modified. At present, new and derivative techniques specific for use in the nanoscale are being developed. The validation of these techniques through interlaboratory comparisons, application across different material types and systems, and so on takes time, but it provides the needed confidence in their use and in the data generated through these techniques.

To counter the time lag issue, practitioners have also adopted the approach of developing measurement protocols32 that are then put to use. Data and experience generated over time from using these protocols help refine the protocols in an iterative manner. These protocols can in turn be used to inform formal standards development. A successful example of this approach is the set of measurement protocols developed by the National Institute of Health's National Cancer Institute Nanotechnology Characterization Lab.33 Recognizing the need to balance timeliness in the development of standardized techniques with the need for greater confidence in data and the measurement techniques, experts in ISO TC229 have chosen to develop technical specifications and technique reports as the first step toward developing international standards. This approach enables experts to review the specifications in approximately 2–3 years and determine aspects of the specifications that need to be updated, changed, eliminated, or formalized. When formalized as international standards, these documents have regular review cycles of 5 years, though they can be reviewed and updated by experts sooner.

1.4.2 Competing Priorities

The promise of nanotechnology has raised significant expectations about the benefits and also raised many questions about safety and conditions under which exposure to nanomaterials might be hazardous. Nanomaterials and nanotechnology are increasingly finding their way into commercially available products. While efforts to quantify the use of nanotechnology and nanomaterials in commerce, such as the Woodrow Wilson Center's Nanotechnology Consumer Product Inventory (which identifies over 1800 commercial products),34 indicate varying numbers of consumer products that are nanoenabled or nanoenhanced, depending upon the scope of the inventory and the methodology, there is no doubt that nanoenabled and nanoenhanced products are being used widely. This growth and associated questions of increased product performance or efficacy due to the “nano” inside, or questions about the safety of these products, are adding pressure to develop more standards to address these questions. As there are only a very limited number of organizations developing nanotechnology-related standards, this demand is competing with standards for other purposes such as property measurement or for definitions. The limited availability of expertise to work on these diverse set of issues, particularly when these issues are in play in either regulatory contexts or in litigation (or the potential for litigation), has set the stage for competing priorities for nanotechnology standards development.