1. Nanotechnology Standardisation
M G Gee
National Physical Laboratory
BSI-Russia Workshop

2. Overview Standards and standardization Role of standards
Standardization organisations
Development of formal standards
Complementary structures
Standardization for nanotechnologies
What needs standardizing and why?
Current standardization committees
Existing standards, standardization projects and proposals
Cooperation, coordination and harmonization

3. Standards Standards can be of two types:
Metrological standards such as the kilogram or second
Written standards
Written Standards provide agreed ways of:
Naming, describing and specifying things
Measuring and testing things
Managing things e.g. quality and environmental management: ISO 9001 and ISO 14000
Reporting things as in e.g. proposed ISO (Social Responsibility)
To:
support commercialisation, market development and established markets
provide a basis for procurement based on technical requirements and quality/environmental management
support appropriate legislation/regulation
Can be NORMATIVE, defining what MUST be done in e.g. a specific test method, or INFORMATIVE, providing information only.
Standards are VOLUNTARY unless called in a contract or regulation.
Can provide a means of “validated quantification”

4. Functions of Standards
Standards can perform any of the following four functions:
Interoperability/Compatibility
as with e.g. nuts and bolts, railway gauges, electrical plugs and outlets, and interoperability standards for computers and telecommunications systems
Quality
Fitness for purpose or safety
Variety reduction/optimization (based on best practice)
E.g. shoe sizes, suit sizes – leading to mass production and price reduction
Information/Measurement
Test and measurement methods for describing, quantifying and evaluating product attributes such as material, processes and functions
DIN has reported that in Europe standardization adds approximately 1% to the value of gross domestic product and that the added value generated by standardisation is at least as important as the value generated by patents! – see “Economic benefits of standardization” Published by DIN German Institute for Standardization e. V.

5. Standardization Standards can be: FORMAL standards are:
FORMAL – developed by independent experts working under the auspices of a National, Regional or International standards body
AFNOR, BSI, DIN, JIS, ………………… (NSBs)
CEN, CENELEC, ETSI…..
ISO, IEC & ITU
INFORMAL – developed by a SDO (Standards Development Organisation)
ASTM, IEEE, SAE, SEMI, VDI…(>600 SDOs IN US)
PRIVATE – developed by a company or trade association
FORMAL standards are:
PROPOSED, DEVELOPED AND APPROVED by the members of the standards body (or an accredited organisation)
Based on CONSENSUS (i.e. no sustained opposition) not necessarily unanimity.

6. Needs for Standardization in Nanotechnology
To support commercialisation and market development
To provide a basis for procurement – technical/quality/environmental management
To support appropriate legislation/regulation
Challenges: currently there are:
No internationally agreed terminology/definitions for nanotechnology(ies).
No internationally agreed protocols for toxicity testing of nanoparticles.
No standardized protocols for evaluating environmental impact of nanoparticles.
Existing “methods of test” may not be suitable for nanoscale devices and nanoscale dimensions.
Measurement techniques and instruments need to be developed and/or standardized.
New calibration procedures and certified references materials are needed for validation of test instruments at the nanoscale.
Multifunction nanotechnology systems and devices will need new standards.
Partial solutions
Some existing standards may be applicable e.g. for chemical analysis and imaging (ISO TCs 201 and 202) and particle detection/sizing (ISO TC 24)

7. Major issues in Nanotechnology Standardisation
Diversity of disciplines impacted by and contributing to nanotechnologies
Global impact
Speed of development and apparent speed of commercialisation
Critical areas:
Coordination and harmonization across standards developers and stakeholders
Terminology
Measurement and characterization
Health, safety and environment

8. Why Standards for Nanotechnologies are Important
Standards will help to ensure that nanotechnology is
developed and commercialised in an open, safe and
responsible manner by supporting:
safety testing, legislation and regulation
worker, public and environmental safety
commercialisation and procurement
patenting and IPR
communication about the benefits, opportunities and potential problems associated with nanotechnologies
This will be achieved by providing agreed ways of:
Naming, describing and specifying things
Measuring and testing things
Health and environmental safety testing, risk assessment and risk management

9. BSI NTI/1 Nanotechnologies
Guides
Guide to Safe Handling and Disposal of Free Engineered Nanoparticles
Guide to Specifying Nanomaterials.
6 PAS documents
Good Practice Guide for Labelling of Engineered Nanoparticles and Products Containing Engineered Nanoparticles
Terminology for Medical and consumer applications of nanotechnologies Terminology for The bio-nano interface Terminology for Common Nanoscale Measurement Terms Including Instrumentation Terminology for Carbon nanostructures
Terminology for Nanofabrication
Terminology for Nanomaterials

10. International Organisation for Standardization committee ISO/TC 229 - Nanotechnologies
Established in June 2005 with UK Chair and Secretariat
40 members – 30 “P” and 10 “O” (see )
Liaisons with 15 other ISO TCs and 7 external bodies – IEC/TC 113, CEN/TCs 137 and 352, Asia Nano Forum, EC JRC, OECD and VAMAS
Exploring additional external liaisons for emerging economies
OECD liaison is particularly important as there is much work being carried out on EHS on manufactured nanoparticles

11. International Electrotechnical Commission Committee IEC/TC 113 – “Nanotechnology Standardization for Electrical and Electronic Products and Systems”
Established June 2006 with US Chair and German secretariat
26 members - 15 “P” and 11 “O”
Agreed to establish two Joint Working Groups with ISO TC/229:
JWG 1 – Terminology and nomenclature
JWG2 – Measurement and characterization
Together with a third Working Group:
WG3 – Performance Assessment
Scope: To develop standards for the assessment of performance, reliability, and durability related to the nanotechnology-enabled aspects of components and systems in support of continuous improvement at all stages of the value adding chain.
Work Item: GUIDE FOR CARBON NANOTUBE SPECIFICATION FOR ELECTROTECHNICAL APPLICATION

12. European Committee for Standardization Committee CEN/TC 352 - Nanotechnologies
Established November 2005 following proposal from UK and recommendations from CEN/BTWG 166
UK Chair and Secretariat
Works closely with ISO/TC 229 and “topics of mutual interest will be developed under the ‘Vienna Agreement’ with ISO lead”.
Developing work programme in areas of specific interest to Europe and areas that will be relevant to European legislation.
Currently 3 projects:
Guide to nanoparticle measurement methods and their limitations (CEN/TR)
Guide to methods for nano-tribology measurements (CEN/TR)
Guide for Labelling of Engineered Nanoparticles and Products Containing Engineered Nanoparticles

13. TC 229 – Structure/working Areas
Terminology and Nomenclature (JWG 1)
“what you call it” - Convened by Canada

14. ISO/TC 229 JWG1: Strategic Roadmap
Project 3
Nanomaterials classification
Base
Definitions
Nanoscale
Nano films
Nano dispersions
Terminology –carbon nanostructures
Terminology – nano-bio interface
Project 4
Nanoscale attribute
Terminology - nanoparticles
Project 1
Nomenclature- Model Options
Nano-processes
Nanoscale objects
Nanotechnologies
Nanostructured
materials
Nanomaterials
Terminology - nanomaterials
Nano-production
Framework and core terms
Project 2
Complex assemblies
Terminology - nanostructures
Terminology - nanofabrication
Nomenclature model
Nanomedical
devices
Nanosensors
Nanomeasurement
Terminology – medical and consumer
Devices and applications
ISO/TS: Terminology and definitions for nanoparticles – Document now approved as TS – awaiting resolution of comments
ISO/TR: Terminology and nomenclature for nanotechnologies — Framework and core terms
ISO/TS: Outline of Nanomaterials classification ("Nano tree")
ISO/TS: Terminology and definitions for carbon nanomaterials
NWIP: ISO/TS: Nanotechnologies - Core Terms - Terminology and Definitions (ballot closes 6 May 2008)
Nanometrology
Nanomeasurement tools
Nanoelectronic
devices
Nanophotonic
devices
Terminology – nanoscale measurement
(IEC) Terminology – nano-optics
(IEC) Vocabulary - electrotechnical

15. TC 229 – Structure/working Areas
Terminology and Nomenclature (JWG 1)
“what you call it” - Convened by Canada
Measurement and Characterization (JWG 2)
“How you measure/test it” – Convened by Japan

16. Support for WG3 activities
ISO/TC 229 JWG2: Draft Roadmap
Carbon Nano-Materials
Basic Character set
Purity Geometrical property
Morphology Dispersability Tube type
Advanced Character set
Electrical, Magnetic, Mechanical , Optical properties
Engineered
nanoparticles
Basic Character set
Purity Composition, Geometrical property, Sampling method.
Advanced Character set
Elemental structure, Chemical functionality,
Electrical, Magnetic, Mechanical , Optical properties
Coatings/
Nanostructured materials
Basic Character set
Geometrical property, Composition, Density
Advanced Character set
Electrical, Magnetic, Mechanical , Optical properties
ISO/TS: The Use of Transmission Electron Microscopy (TEM) in the Characterization of Single-walled Carbon Nanotubes
ISO/TS: The Use of Scanning Electron Microscopy (SEM) and Energy Dispersive X-ray Analysis (EDXA) in the Characterization of Single-walled Carbon Nanotubes
ISO/TS: Technical Specification for the Use of UV-Vis-NIR absorption spectroscopy in the Characterization of Single-walled Carbon Nanotubes
ISO/TS: Technical Specification for the use of NIR-Photoluminescence (NIR-PL) Spectroscopy in the Characterization of Single-Walled Carbon Nanotubes
ISO/TR: Use of Thermo Gravimetric Analysis (TGA) in the purity evaluation of Single Walled Carbon Nanotubes
ISO/TR: Use of Evolved Gas Analysis-Gas Chromatograph Mass Spectrometry (EGA-GCMS) in the Characterization of Single-Walled Carbon Nanotubes
ISO/TS: Use of Raman Spectroscopy in the Characterization of Single Walled Carbon Nanotubes.
ISO/TS: Measurement Methods for the Characterization of Multi-Walled Carbon Nanotubes
ISO/TS: Determination of meso-scopic shape factors of multiwalled carbon nanotubes
ISO/TS: General Framework for Determining Nanoparticle Content in Nanomaterials by Generation of Aerosols
Basic Metrology
Length, Depth, Force, Traceability, Definition of Measurand, Uncertainty
Interoperability
Support for WG3 activities 16 16

17. TC 229 – Structure/working Areas
Terminology and Nomenclature (JWG 1)
“what you call it” - Convened by Canada
Measurement and Characterization (JWG 2)
“How you measure/test it” – Convened by Japan
Health, Safety and Environment (WG 3)
“what effect it might have on health and the environment”
– Convened by USA

18. Standard Methods for Toxicological
ISO/TC 229 WG3 : Strategic Roadmap
Standard Methods for Controlling Occupational Exposures to Nanomaterials
Standard Methods for Determining Relative Toxicity/Hazard Potential of Nanomaterials
Standard Methods for Toxicological
Screening
of Nanomaterials
Future NWIP TBD
Future Screening
Test TBD
In vivo Tox Test TBD
In vitro Tox Test TBD
Metrology TBD
Terminology TBD
Nanoparticle
Inhalation Testing
Workplace Monitoring
Metrology TBD
Terminology TBD
Current
Practices TR
Future Occupational
Standards TBD
Nanoparticle
Toxicity Testing
Sequence
Physico-Chemical
characterization
Endotoxin Test
ISO/TR: Safe Practices in Occupational Settings Relevant to Nanotechnologies – should be balloted shortly.
ISO/IS: Endotoxin test on nanomaterial samples for in vitro systems
ISO/IS: Generation of nanoparticles for inhalation toxicity testing
ISO/IS: Monitoring of nanoparticles in inhalation exposure chambers for inhalation toxicity testing
ISO/TR Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment.
Metrology TBD
Terminology TBD
2008
2009
2010
2011

19. TC 229 – Structure/working Areas
Support for “REGULATION” and voluntary governance structures
Material Specifications (WG4)
(Convened by China)
PRODUCT AND PROCESS (sc)
PRODUCT AND PROCESS (sc)
Terminology and Nomenclature (JWG 1)
“what you call it” - Convened by Canada
Measurement and Characterization (JWG 2)
“How you measure/test it” – Convened by Japan
Health, Safety and Environment (WG 3)
“what effect it might have on health and the environment”
– Convened by USA

20. TC 229 Current Work Programme – JWG1
ISO/TS: Terminology and definitions for nanoparticles - completed
ISO/TR: Terminology and nomenclature for nanotechnologies — Framework and core terms
ISO/TS: Terminology and definitions for carbon nanomaterials (Japan)
ISO/TS: Core Terms - Terminology and Definitions
New work item proposals:
ISO/TS: Terminology for nanoscale measurement and instrumentation
ISO/TS: Terminology for the bio-nano interface
ISO/TS: Terminology for medical, health and personal care applications of nanotechnologies
ISO/TS: Terminology for nanofabrication/nanomanufacturing
Committee resource document:
Outline of Nanomaterials classification ("Nano tree")

21. TC 229 Work programme – JWG2 – SWCNT work
ISO/TS: The Use of Transmission Electron Microscopy (TEM) in the Characterization of Single-walled Carbon Nanotubes (US/Japan)
ISO/TS: The Use of Scanning Electron Microscopy (SEM) and Energy Dispersive X-ray Analysis (EDXA) in the Characterization of Single-walled Carbon Nanotubes (US)
ISO/TS: Technical Specification for the Use of UV-Vis-NIR absorption spectroscopy in the Characterization of Single-walled Carbon Nanotubes (Japan)
ISO/TS: Technical Specification for the use of NIR-Photoluminescence (NIR-PL) Spectroscopy in the Characterization of Single-Walled Carbon Nanotubes (Japan)
ISO/TR: Use of Thermo Gravimetric Analysis (TGA) in the purity evaluation of Single Walled Carbon Nanotubes (US/Korea)
ISO/TR: Use of Evolved Gas Analysis-Gas Chromatograph Mass Spectrometry (EGA-GCMS) in the Characterization of Single-Walled Carbon Nanotubes (Japan)
ISO/TS: Use of Raman Spectroscopy in the Characterization of Single Walled Carbon Nanotubes (US)

22. JWG2 – MWCNT and Other Work
ISO/TS: Measurement Methods for the Characterization of Multi-Walled Carbon Nanotubes (Japan)
ISO/TS: Determination of meso-scopic shape factors of multiwalled carbon nanotubes (Korea)
ISO/IS: General Framework for Determining Nanoparticle Content in Nanomaterials by Generation of Aerosols
Joint developments with CEN (CEN lead):
ISO/TR: Guide to nanoparticle measurement methods
ISO/TR: Guide to methods for nano-tribology measurements
NWIP under joint ballot:
Sample Preparation for 4-Probe Measurement of Electrical Properties of CNTs (Korea)

23. TC 229 Work Programme – WG3
ISO/TR: Safe Practices in Occupational Settings Relevant to Nanotechnologies – completed
Under CD ballot
ISO/IS: Endotoxin test on nanomaterial samples for in vitro systems
ISO/IS: Standard for Generation of Metal Nanoparticles with the Evaporation/Condensation Method for inhalation toxicity testing
ISO/IS: Standard for characterization of nanoparticles in inhalation exposure chambers for inhalation toxicity testing
ISO/TR Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment.
New work item proposal:
Guide to safe handling and disposal of manufactured nanomaterials

24. TC 229 Work programme – Materials specifications (WG4)
ISO/TS: Materials specification for nano-titanium dioxide
ISO/TS: Materials specification for nano-calcium carbonate
New Work Item Proposal
Guide to specifying nano-materials

25. Current and potential liaisons for ISO/TC 229
Packaging
ISO/TC 206
Fine ceramics
ISO/TC 217
Cosmetics
ISO/TC 119
Powder metallurgy
ISO/TC 84
Devices for administration of medical products and intravascular catheters
MATERIALS
ISO/TC 107
Metallic and other inorganic coatings
BIOMEDICAL
ISO/TC150
Implants for surgery
ISO/TC 91
Surface active agents
ISO/TC 168
Prosthetics and orthotics
ISO/TC 61
Plastics
EXTERNAL LIAISONS
RISK/HS&E
ISO/TC 212
Clinical laboratory testing and in vitro diagnostic test systems
ISO/TC 59
Building construction
ISO/TC 215
Health Informatics
ISO/TC 38
Textiles
NANO-PARTICLES
METROLOGY AND
CHARACTERIZATION
ISO/TC 225
Market opinion and social research
ISO/TC 35
Paints and varnishes
ISO/TC 215
Environmental management
ISO/TC 34
Food products
ISO/TC 28
Petroleum and petroleum products
ISO/TC 48
Laboratory equipment
ISO/TC 172
Optics and photonics
ISO/TC 180
Solar energy
ISO/TC 184
Industrial automation systems and integration
ISO/TC 203
Technical energy systems
ENERGY

26. CURRENT AND POTENTIAL LIAISONS – IEC/TC 113
Electromechanical components and mechanical structures for electronic components
IEC/TC 59
Performance of household electrical appliances
SEMI
IEEE
IEC/TC 34
Lamps and
related
equipment
IEC/TC 113
Nanotechnology
Standardization
for electrical
and electronic
products and
systems
IEC/TC 105
Fuel cell technologies
IEC/TC 86
Fibre optics
IEC/TC 21
Secondary cells and batteries
IEC/TC 110
Flat panel displays
IEC/TC 235
Primary cells and batteries
IEC/TC 82
Solar photovoltaic energy systems

27. Complementary structures: e. g
Complementary structures: e.g. OECD Test Guidelines for testing of chemicals
SECTION 1 - PHYSICAL-CHEMICAL PROPERTIES
SECTION 2 - EFFECTS ON BIOTIC SYSTEMS
SECTION 3 - DEGRADATION AND ACCUMULATION
SECTION 4 - HEALTH EFFECTS
For laboratories complying with “GLP”, “MAD” applies

28. OECD WPMN Projects
Development of an OECD (Nanosafety) Database on Human Health and Environmental Safety (EHS) research
EHS Research Strategies on Manufactured Nanomaterials
Safety Testing of a Representative Set of Manufactured Nanomaterials
Manufactured Nanomaterials and Test Guidelines
Co-operation on Voluntary Schemes and Regulatory Programmes
Co-operation on Risk Assessments and Exposure Measurements
The Role of Alternative Methods in Nano Toxicology
Co-operation on Exposure Measurements and Exposure Mitigation

29. Sponsorship programme for testing a “representative set” of manufactured nanomaterials
Fullerenes (C60)
Single walled carbon nanotubes
Multi walled carbon nanotubes
Carbon black
Nanoparticle (NP) silver
NP iron
NP aluminium oxide
NP cerium oxide
NP silicon dioxide
NP titanium dioxide
NP zinc oxide
Nanoclays
NP polystyrene
Dendrimers
+ Guidance manual for sponsors – including guidance on sample preparation and dosimetry

30. Cooperation/Coordination/Harmonization
Close cooperation with OECD WPMN
International Workshop on Documentary Standards for Measurement and Characterization for Nanotechnologies – 02/08, joint workshop with IEC, OECD and NIST (see )
Terminology coordination through ISO/TC 229/JWG1
Nanotechnologies Liaison Coordination Group