Nanotechnology Standards (eBook)

Preface 6
Contents 10
Contributors 12
Chapter 1: Introduction* 16
1.1 Introduction 16
1.2 History of Standards 17
1.2.1 Community Standards Development 17
1.2.2 National Standards Development 18
1.2.3 International Standards Development 21
1.2.4 Global Standards Development 25
1.2.5 Emerging Development of Nanotechnology Standards 29
1.3 Conclusion 31
References 32
Chapter 2: Current Perspectives in Nanotechnology Terminology and Nomenclature 35
2.1 Introduction 35
2.2 Terminology 37
2.2.1 Non-SDO Sources 38
2.2.2 ASTM International 44
2.2.3 ISO TC 229 47
2.2.4 Concluding Terminology Comments 51
2.3 Nomenclature and Nanotechnology 52
2.3.1 Why is Nomenclature Useful in Relation to Standards? 53
2.3.2 Nomenclature Challenges 55
2.3.3 Standards Development Organizations and Nomenclature for Nanotechnology 56
2.3.4 Overview of Recognized Chemical Nomenclature Bodies 57
2.3.5 Other Concept 60
2.3.6 Possible Parameters for a Nanotechnology Nomenclature System 60
2.3.7 The Distinction Between Characterization and a Name 62
2.3.8 Future Nomenclature Directions 63
2.4 Final Remarks 63
References 64
Chapter 3: Nanoscale Reference Materials 67
3.1 Introduction 67
3.1.1 The Growing Use of Reference Materials 67
3.1.2 The Term “Nanoscale” 68
3.1.3 Nanotechnology Needs Reference Materials 69
3.1.4 Structure of the Chapter 69
3.2 Generic Issues in Reference Materials Production and Use 69
3.2.1 The Role of ISO/REMCO 69
3.2.2 Reference Material 70
3.2.2.1 Homogeneity 70
3.2.2.2 Stability 71
3.2.2.3 Notes to the RM Definition 71
3.2.3 Certified Reference Material 72
3.2.3.1 Metrologically Valid Characterisation 72
3.2.3.2 Certificate 72
3.2.3.3 Uncertainty of the Certified Value 73
3.2.3.4 Metrological Traceability 73
3.2.4 Different Usage of Certified and Non-certified RMs 73
3.2.4.1 Accuracy, Trueness and Precision 73
3.2.4.2 Calibration 74
3.2.4.3 Method Validation 74
3.2.4.4 Statistical Quality Control 74
3.2.4.5 Interlaboratory Comparisons 75
3.3 Critical Issues Related to Nanoscale RMs 75
3.3.1 Definition of the “Measurand” 75
3.3.2 Traceability Statements 76
3.3.3 Laboratory Qualification 77
3.3.4 Homogeneity and Stability 77
3.3.4.1 Homogeneity at the Nanoscale 77
3.3.4.2 Stability of Nanoscale Structural Features 78
3.4 Examples of RMs for Nanotechnology 78
3.4.1 Areas of Application for Nanoscale Reference Materials 78
3.4.2 A Database of Existing Nanoscale RMs 79
3.4.3 RMs for Nanoparticle Size Analysis 80
3.4.4 RMs for Measurement of Film Thickness 81
3.4.5 RMs for Chemical Contrast Imaging 82
3.4.6 RMs for Measurement of Surface Topography 83
3.4.7 RMs for Surface Area Measurements 83
3.4.8 RMs for Powder Porosity Measurements 84
3.4.9 RMs for Carbon Nanotube Characterisation 84
3.5 Current Developments and Trends for the Future 85
3.5.1 Scientific Challenges for Nanoscale RMs 85
3.5.2 Laboratory Accreditation and Regulation 86
3.5.3 Collaboration 86
References 87
Chapter 4: Nanoscale Metrology and Needs for an Emerging Technology 90
4.1 Introduction 90
4.2 International Cooperation 91
4.3 Evaluation of Measurement Uncertainty 93
4.4 Metrology & Industry: An Example from Length Calibration
4.5 Key Elements of Metrology Currently in Use 95
4.6 Redundancy vs. Duplication 97
4.7 Current State-of-Play and Trends 97
References 99
Chapter 5: Performance Standards 101
5.1 Support of Successful Industrialization of Nanotechnology by Anticipative Standardization of Performance Testing: The Gen 101
5.1.1 Why Are Performance Standards Needed? 101
5.1.2 Anticipative Standardization 106
5.1.3 Nanotechnology Standards and Existing Standards 108
5.2 How to Practically Create Standards Through the Whole Value Adding Chain/Supply Chain 108
5.2.1 Quality and Process Management 108
5.2.2 Key Control Characteristics as Direct and Indirect Performance Parameters, and Their Role in a QM System 110
5.2.3 The Quality Function Deployment Method to Identify KCCs 112
5.3 Nanoelectronics Standardization: First Steps and Practical Experience 115
5.3.1 The Microelectronics Industry: High Quality Standards and a High Rate of Innovation 116
5.3.2 Safety Aspects: Cleanroom Technology, Small Quantities of Nanomaterials, Encapsulation of Nanosubassemblies 117
5.3.3 The Experience So Far: Current Projects in IEC TC113 118
5.3.3.1 Example 1: IEC 62565-2-1 Nanomanufacturing – Material Specification Part 2-1: Blank Detail Specification for Single W 120
5.3.3.2 Example 2: IEC/TS 62607-2-1 Nanomanufacturing – Key Control Characteristics Part 2.1: Carbon Nanotube Materials – Fil 123
5.4 Future Developments 124
5.5 Conclusions 126
References 127
Chapter 6: Current Standardization Activities of Measurement and Characterization for Industrial Applications 129
6.1 Introduction 129
6.2 Standardization for Measurement/Characterization of Engineered Nanomaterials Including Nanotubes (Activities of ISO/TC 2 134
6.2.1 Representative Engineered Nano-materials 134
6.2.2 Standardization of MWCNT Characterization 136
6.2.3 Standardization of SWCNT Characterization 138
6.2.4 Necessity of Standardization for the Characterization of Other Engineered Nanomaterials 141
6.3 Standardization of Analytical Techniques for Nanocoating/Structure Measurement (Activities of ISO/TC 201 on Surface Chem 144
6.3.1 Standardization in ISO/TC 201 for Surface Chemical Analysis as a Tool to Characterize Surfaces and Interfaces of Nano-c 144
6.3.2 Standardization of SPM in ISO/TC 201/SC 9 147
6.3.3 Potential Use of International Standards Published by ISO/TC 201 for Nano-coating/Structure Characterization 151
6.3.4 On-Going Project in ISO/TC 201 for Characterization of Nanostructured Materials 155
6.4 Application Measurement in Other Standard Organizations 161
6.4.1 International Workshop on Documentary Standards for Measurement and Characterization 161
6.4.2 Activities of ISO/TC 24/SC 4 (Standardization of Particle Characterization) 162
6.4.3 IEC/TC 113 165
6.4.4 CEN/TC 352 167
6.4.5 ASTM International E42 and E56 Committees 167
6.4.6 IEEE Nanotechnology Standards Working Group 169
6.5 Conclusion 171
6.5.1 Standardization for Characterization from Nano-materials to Nano-intermediates 171
References 172
Chapter 7: Implications of Measurement Standards for Characterizing and Minimizing Risk of Nanomaterials 176
7.1 Introduction 176
7.2 Risk Paradigm 177
7.3 Nanotechnology Standards Development 178
7.4 Relating Measurement Standards to the Risk Paradigm 180
7.4.1 Nano-object Content of Powders 180
7.4.2 Metal Aerosol Inhalation Standards 183
7.4.3 Quantification of Endotoxin in Nanomaterials 184
7.5 Summary 186
References 187
Chapter 8: Nanomaterial Toxicity: Emerging Standards and Efforts to Support Standards Development 189
8.1 Introduction 189
8.2 International Efforts Related to Nanotoxicology 196
8.2.1 OECD 196
8.2.2 ISO Technical Committee on Nanotechnologies 199
8.2.3 ASTM International 203
8.3 Need for Validation in Toxicity Testing and Assay Validation Efforts 204
8.3.1 Need for Validation in Toxicity Testing 204
8.3.2 Efforts to Support Validation of Toxicological Testing and the Development of Standards 205
8.3.2.1 NCI-NCL 205
8.3.2.2 International Alliance for NanoEHS Harmonization 206
8.3.2.3 ASTM International’s Interlaboratory Studies 207
8.3.2.4 European Network on the Health and Environmental Impact of Nanomaterials and European Center for the Validation of 208
8.3.2.5 NanoInteract 209
8.4 Future 210
8.4.1 Where Standards Are Needed: Opportunities for the Future 210
8.4.2 Harmonization and the Role of Standards 214
8.4.3 The Future of International Cooperation in Nanotoxicology 215
References 216
Chapter 9: Health and Safety Standards* 219
9.1 Introduction 219
9.2 Exposure Limits 220
9.3 Hazard Communication 224
9.3.1 Material Safety Data Sheets 224
9.3.2 Labeling 225
9.3.3 Globally Harmonized System 228
9.4 Risk Mitigation 229
9.4.1 Occupational Guidance 229
9.4.2 Environmental and Consumer Guidance 235
9.4.3 Comprehensive Risk Management Frameworks 236
9.5 Codes of Conduct 237
9.6 Future Directions 239
9.6.1 Trends and Outlook 239
9.6.2 Performance-Based Risk Management Program for Nanotechnology 240
9.6.3 Global Health and Safety Standards Development Coordination 241
9.7 Conclusion 242
References 242
Chapter 10: Nanotechnology Standards and International Legal Considerations 249
10.1 Introduction 249
10.2 Standards Are Not Laws 250
10.3 Standards and Government Decision-Making 251
10.4 Standards and Intellectual Property 253
10.5 Standards and Corporate Transactions 254
10.6 Standards and Environment, Health, and Safety Regulation 254
10.7 Standards and Consumers 255
10.8 Standards and International Trade 257
10.9 Standards and Risk Management 260
10.10 When Standards Are More Strict than the Law 261
10.11 Incorporating Nanotechnology Standards into the Fabric of the Law 261
10.12 Conclusions 264
Index 266