1. An introduction to standards and standardization for nanotechnologies
Dr Peter Hatto,
Chairman UK NTI/1 and ISO TC 229 Nanotechnologies Standardization committees
Read more at BSI’s nanotechnology website for standards and news

2. Overview Why standards for nanotechnologies are important
Standards and standardization
Role of standards
Standardization organisations
Development of formal standards
Standardization for nanotechnologies
Why are nanotechnologies important
Major challenges for standardization
Current International and European standardization committees
Existing standards and standardization projects
Cooperation, coordination and harmonization

3. Why standards for nanotechnologies are important
Standards will help to ensure the open, safe and responsible development of nanotechnologies 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
By providing agreed ways of:
Naming, describing and specifying things
Measuring and testing things
Protocols for health and environmental safety testing, risk assessment and risk management

4. Standards Two types of standards:
Metrological standards
Written (‘documentary’) standards
Written Standards provide agreed ways of:
Naming, describing and specifying things
Measuring and testing things
Managing things e.g. quality and environmental emissions: ISO 9001 and ISO 14000
Reporting things as in e.g. proposed ISO (Social Responsibility)
To:
Support innovation, commercialisation, market development and established markets
Provide a basis for procurement
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 incorporated into a contract or
regulation.
Standards are based on CONSENSUS not necessarily unanimity

5. Standards – “not essential to life but absolutely essential to modern living”
Standards are:
Ubiquitous – covering such things as shoe sizes, nuts and bolts, petrol grades, warning signs, pipes and fittings, fire extinguishers, gas cylinders, shipping containers, electrical sockets and plugs, steel specifications,…………..
Virtually invisible to “the man in the street” – there are over 16,500 International Standards, many with multiple parts;
Absolutely critical to our modern way of life – covering things such as:
internet protocols,
aircraft fuels
credit cards,
business continuity management
quality and environmental management,
carbon trading,
sustainable development
life cycle costing
…………………………………..

6. NWIP from member organisation
Development of International Standards
Process accommodates special needs
NWIP from member organisation
Approval – at least 5 P members agree to participate and >50% of members voting are in favour
First level of
consensus
(amongst experts) {
Second level of consensus (amongst members of ISO)
Also ISO/TR
for informative documents

7. Why is nanotechnology important?
US Interagency Working Group on Nano Science, Engineering and Technology (IWGN) workshop on Nanotechnology Research Directions (Sept. ’99):
“nanotechnology will be a strategic branch of science and engineering for the 21st century, one that will fundamentally restructure the technologies currently used for manufacturing, medicine, defence, energy production, environmental management, transportation, communication, computation and education.”
US NSF report on “SOCIETAL IMPLICATIONS OF NANOSCIENCE AND NANOTECHNOLOGY” March 2001:
“the impact of nanotechnology in the 21st century is likely to be at least as significant for health, wealth and security as the combined influences of antibiotics, integrated circuits and polymers.”
Projected world-wide market for n-t enabled products will be >$500 Billion but <$3 trillion by 2015
“It is estimated that Nanotechnology is presently at a level of development similar to that of computer/information technology in the 1950s” (Nanostructure Science and Technology: A Worldwide Study, WTEC Panel report, 1999)

8. The challenges
The Interagency Working Group on Nanotechnology workshop in 1999 concluded:
“while recognizing nanotechnology’s potential to spawn an industrial revolution in coming decades, the consensus was that the challenges ahead in basic discovery, invention and eventual manufacturing are formidable. New methods of investigation at the nanoscale, novel scientific theories, and different fabrication paradigms are critical.”
“Nanotechnolgy will only become a coherent field of endeavour through the confluence of three important technological streams:
New and improved control of the size and manipulation of nanoscale building blocks;
New and improved characterization (spatial resolution, chemical sensitivity, etc) of materials at the nanoscale;
New and improved understanding of the relationship between nanostructure and properties and how these can be engineered”
And don’t forget safety and consumer acceptance!!

9. Major challenges for standardization for nanotechnologies
Diversity of disciplines impacted by and contributing to nanotechnologies
Global impact
Rapid speed of development and apparent speed of commercialisation (over 800 consumer products on the market – see Woodrow Wilson International Center for Scholars inventory: )
Critical areas:
Coordination and harmonization across standards developers and stakeholders
Terminology
Measurement and characterization
Health, safety and environmental issues
Material specifications

10. International Organisation for Standardization ISO/TC 229 - Nanotechnologies
Established in June 2005
44 members – 36 “P” and 8 “O” (see )
Works closely with IEC/TC 113 and CEN/TC 352
Liaisons with 26 ISO/IEC/CEN TCs and 9 external bodies –Asia Nano Forum, BIPM, EC JRC, ECOS, ETUI, IRMM, IUPAC, OECD and VAMAS
Exploring additional external liaisons with other groups and with emerging economies

11. Established June 2006 with US Chair and German secretariat
International Electrotechnical Commission IEC/TC 113 – “Nanotechnology standardization for electrical and electronic products and systems”
Established June 2006 with US Chair and German secretariat
32 members - 18 “P” and 14 “O”
Agreed to establish two Joint Working Groups with ISO/TC 229:
JWG 1 – Terminology and nomenclature
JWG 2 – Measurement and characterization
Together with a third Working Group:
WG 3 – Performance assessment

12. Established November 2005 following a recommendation from CEN/BTWG 166
European Committee for Standardization CEN/TC Nanotechnologies
Established November 2005 following a recommendation from CEN/BTWG 166
French chair and joint French/Czech Republic secretariat
All 30 members of CEN are notionally members – around 14 active
Works closely with ISO/TC 229 using the ‘Vienna Agreement’ for cooperative working.
Developing a work programme to include areas of specific interest to Europe and areas that will be relevant to European legislation.
Coordinating work programme to address European Commission mandate M/461 for standardization activities regarding nanotechnologies and nanomaterials.
Two working groups established in September 2008:
WG 1 'Measurement, characterization and performance evaluation'
WG 2 'Commercial and other stakeholder aspects'

13. Published standards and work programmes – ISO, IEC and CEN
ISO/TC 229, Published standards see:
Work programme see:
IEC/TC 113, Published standards see:
CEN/TC 352, Published standards see:

14. UK Publications and work programme
Publicly Available Specifications (PAS):
PAS 71 Vocabulary – Nanoparticles (under revision)
PAS 131 Terminology for medical, health and personal care applications of
nanotechnologies
PAS 132 Terminology for the bio-nano interface
PAS 133 Terminology for nanoscale measurement and instrumentation
PAS 134 Terminology for carbon nanostructures
PAS 135 Terminology for nanofabrication
PAS 136 Terminology for nanostructured materials
PAS 130 Guidance on the labelling of manufactured nanoparticles
and products containing manufactured nanoparticles
Published Documents (PD)
PD Guide to specifying nanomaterials
PD Guide to safe handling and disposal of manufactured
nanomaterials
PD Guide to assessing airborne exposure in occupational
settings relevant to nanomaterials
All documents are available for free download at except PD
Under development: PAS Nanomaterials and nanotechnology-based products – Guidance on legislation and standards for SMEs

15. ISO TC 229 – Horizontal activities 1
Terminology and Nomenclature (JWG 1)
“what you call it” - Convened by Canada

16. ISO/TC 229 JWG1: Strategic Roadmap
Framework and core terms
Base
Definitions
Nano films
Nano dispersions
Terminology –carbon nanostructures
Nomenclature model
Nano-processes
Terminology - nanoparticles
Nanomaterials classification
Terminology – nano-bio interface
Nanoscale objects
Nanostructured
materials
Nanotechnologies
Nanomaterials
Terminology - nanomaterials
Nano-production
Complex assemblies
Terminology - nanostructures
Terminology - manufacturing
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

17. ISO TC 229 – Horizontal activities 2
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

18. 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 18 18

19. ISO TC 229 – Horizontal activities 3
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. ISO/TC 229 WG3 : Strategic Roadmap
Toxicological
Screening
of Nanomaterials
- cooperation with OECD WPMN
Controlling Occupational Exposures to Nanomaterials
Determining Relative Hazard Potential of Nanomaterials
Future NWIP TBD
Future Screening
Test TBD
MSDS guidance
Future NWIP TBD
Risk management
‘control banding’
Sequence
Nanoparticle
Inhalation Testing
Risk evaluation
framework
Support to
In vivo Tox Test TBD
Physico-Chemical
characterization
Safe handling guidance
Support to
In vitro Tox Test TBD
Current Practices
Endotoxin Test
Metrology TBD
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.
Workplace Monitoring
Metrology TBD
Metrology TBD
Terminology TBD
Terminology TBD
Terminology TBD
2007……..8……….9………10...
2007……..8……….9………10.
2010……..11…….12…..

21. ISO 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

22. WG4 – current work programme

23. Other TC 229 structures Chairman’s Advisory Group Task Groups on:
Planning and Coordination;
Nanotechnologies and Sustainability;
Societal and Consumer Dimensions of Nanotechnologies.
Nanotechnologies Liaison Coordination Group (NLCG)
JWG2 Study Groups on:
Metrology
Strategy

24. Current and potential liaisons for ISO/TC 229
Metallic and other inorganic coatings
ISO/TC 38
Textiles
ISO/TC 206
Fine ceramics
ISO/TC 122
Packaging
ISO/TC 119
Powder metallurgy
ISO/TC 91
Surface active agents
ISO/TC 84
Devices for administration of medical products and intravascular catheters
MATERIALS
BIOMEDICAL
ISO/TC 61
Plastics
Current and potential liaisons for ISO/TC 229
ENERGY
ISO/TC 168
Prosthetics and orthotics
ISO/TC 212
Clinical laboratory testing and in vitro diagnostic test systems
ISO/TC 215
Health Informatics
ISO/TC 225
Market opinion and social research
Environmental management
ISO/TC 28
Petroleum and petroleum products
ISO/TC 180
Solar energy
ISO/TC 203
Technical energy systems
ISO/TC 184
Industrial automation systems and integration
ISO/TC 172
Optics and photonics
ISO/TC150
Implants for surgery
ISO/TC 217
Cosmetics
ISO/TC 34
Food products
ISO/TC 48
Laboratory equipment
NANO-PARTICLES
METROLOGY AND
CHARACTERIZATION
EXTERNAL LIAISONS
RISK/HS&E
BIPM
ISO/TC 142
Cleaning equipment for air and other gases
ISO/TC 59
Building construction
ISO/TC 35
Paints and varnishes
ISO/TC 45
Rubber and rubber products

25. The roles of ISO/TC 229, IEC/TC 113 and CEN/ TC 352 will be to identify requirements in cooperation with stakeholders, including industry, governments, regulators, OECD, the European Commission, and the public, to coordinate standards development with relevant TCs, and to develop standards where no TC exists or where the existing TC does not have the necessary resources.

26. Why standards for nanotechnologies are important
Standards will help to ensure the open, safe and responsible development of nanotechnologies 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
By providing agreed ways of:
Naming, describing and specifying things
Measuring and testing things
Protocols for health and environmental safety testing, risk assessment and risk management
Read more at BSI’s nanotechnology website for standards and news