Nanotechnology Standardisation

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 26000
  (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 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(gt600 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
  http//www.iso.org/iso/standards_development/techn
  ical_committees/list_of_iso_technical_committees/i
  so_technical_committee.htm?commid381983 )
• 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
• http//www.iec.ch/cgi-bin/procgi.pl/www/iecwww.p?w
  wwlangewwwprogdirdet.pprogdbdb1css_colorpur
  plecommitteeTCnumber113
• 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

• http//www.cen.eu/CENORM/Sectors/TechnicalCommitte
  esWorkshops/CENTechnicalCommittees/CENTechnicalCom
  mittees.asp?param508478titleCEN2FTC352
• 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
Nanomaterials classification
Project 3
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
Nanostructured materials
Nanotechnologies
Nanomaterials
Terminology - nanomaterials
Nano-production
Framework and core terms
Project 2
Complex assemblies
Terminology - nanostructures
Terminology - nanofabrication
Nomenclature model
Nanomedical devices
Nanosensors
Nanomeasurement
Devices and applications
Terminology medical and consumer
Nanometrology
Nanomeasurement tools
Nanoelectronic devices
Nanophotonic devices
Terminology nanoscale measurement
(IEC) Vocabulary - electrotechnical
(IEC) Terminology nano-optics
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
ISO/TC 229 JWG2 Draft Roadmap
2005 2010 2015
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
Basic Metrology
Length, Depth, Force, Traceability, Definition of
Measurand, Uncertainty
Interoperability
Support for WG3 activities
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
ISO/TC 229 WG3 Strategic Roadmap
Future NWIP TBD
Nanoparticle Inhalation Testing
Nanoparticle Toxicity Testing
Sequence
Physico-Chemical characterization
Endotoxin Test
Metrology TBD
Terminology TBD
2008
2010
2009
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/nanomanufa
  cturing
• 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
MATERIALS
BIOMEDICAL
EXTERNAL LIAISONS
RISK/HSE
NANO-PARTICLES
METROLOGY AND CHARACTERIZATION
ISO/TC 48 Laboratory equipment
ENERGY
26
CURRENT AND POTENTIAL LIAISONS IEC/TC 113
SEMI
IEEE
IEC/TC 34 Lamps and related equipment
IEC/TC 113 Nanotechnology Standardization for
electrical and electronic products and systems
27
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 http//www.iso.org/nanotec
  h-workshop )
• Terminology coordination through ISO/TC 229/JWG1
• Nanotechnologies Liaison Coordination Group