nanotechnology standardisation m g gee national physical laboratory bsi-russia workshop
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Nanotechnology Standardisation
M G Gee
National Physical Laboratory
BSI-Russia Workshop
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
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”
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.
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…(>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.
Needs for Standardization in Nanotechnology
1. To support commercialisation and market development
2. To provide a basis for procurement – technical/quality/environmental management
3. 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)
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
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
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/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=381983 )
• 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
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?wwwlang=e&wwwprog=dirdet.p&progdb=db1&css_color=purple&committee=TC&number=113
• 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
European Committee for Standardization Committee CEN/TC 352 - Nanotechnologies
– http://www.cen.eu/CENORM/Sectors/TechnicalCommitteesWorkshops/CENTechnicalCommittees/CENTechnicalCommittees.asp?param=508478&title=CEN%2FTC+352
– 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
TC 229 – Structure/working Areas
Terminology and Nomenclature (JWG 1)“what you call it” - Convened by Canada
Project 2
Project 4
ISO/TC 229 JWG1: Strategic Roadmap
Nanosensors
Nanoelectronicdevices
Devices and applications
Nanophotonicdevices
Terminology – medical and consumer
(IEC) Terminology – nano-optics
(IEC) Vocabulary - electrotechnical
Nanomedicaldevices
Nanotechnologies
Nanomeasurement
Nano-production
Nano-processes
BaseDefinitions
Nanoscale attribute
Nanoscale
Framework and core terms
Terminology - nanofabrication
Terminology – nanoscale measurement
Terminology – nano-bio interface
Nomenclature model
Nanometrology Nanomeasurement tools
Nano films
Nanostructuredmaterials
Complex assemblies
Nanoscale objects
Nanomaterials
Terminology - nanoparticles
Terminology - nanostructures
Terminology –carbon nanostructures
Terminology - nanomaterials
Nano dispersions
Nomenclature- Model Options
Project 1
Nanomaterials classificationProject 3
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
ISO/TC 229 JWG2: Draft Roadmap
Advanced Character set Electrical, Magnetic, Mechanical , Optical properties
Carbon Nano-Materials
Engineered nanoparticles
Coatings/Nanostructured materials
Basic Metrology
Basic Character set Purity Geometrical property Morphology Dispersability Tube type
2005 2010 2015
Advanced Character set Elemental structure, Chemical functionality, Electrical, Magnetic, Mechanical , Optical properties
Basic Character set Purity Composition, Geometrical property, Sampling method.
Advanced Character setElectrical, Magnetic, Mechanical , Optical properties
Basic Character set Geometrical property, Composition, Density
Length, Depth, Force, Traceability, Definition of Measurand, Uncertainty
Interoperability
Support for WG3 activities
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
Standard Methods for Toxicological
Screening of Nanomaterials
Standard Methods for Determining Relative
Toxicity/Hazard Potential of Nanomaterials
Standard Methods for Controlling Occupational
Exposures to Nanomaterials
Future ScreeningFuture ScreeningTest TBDTest TBD
In vivo Tox Test TBD
In vitro Tox Test TBD
Metrology TBD
Terminology TBD
Workplace MonitoringWorkplace Monitoring
Metrology TBDMetrology TBD
Terminology TBDTerminology TBD
Current Practices TR
Future OccupationalStandards TBD
2008 20102009
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Nanoparticle Nanoparticle Toxicity TestingToxicity Testing
Physico-Chemical Physico-Chemical characterizationcharacterization
Endotoxin TestEndotoxin Test
Metrology TBDMetrology TBD
Terminology TBDTerminology TBD
Nanoparticle Nanoparticle Inhalation TestingInhalation Testing
Future NWIP TBD
ISO/TC 229 WG3 : Strategic Roadmap
2011
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”
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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")
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)
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)
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
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
ISO/TC 107Metallic and
other inorganic coatings
ISO/TC 38
Textiles
ISO/TC 59
Building construction
ISO/TC 206
Fine ceramics
ISO/TC 122
PackagingISO/TC 119
Powder metallurgy
ISO/TC 91
Surface active agents
ISO/TC 84Devices for
administration of medical products and intravascular
catheters
MATERIALS BIOMEDICAL
Current and potential liaisons for ISO/TC 229
ISO/TC 61
Plastics
ENERGY
ISO/TC 168Prosthetics
and orthotics
ISO/TC 212Clinical
laboratory testing and in
vitro diagnostic test systems
ISO/TC 215Health
Informatics
ISO/TC 225Market
opinion and social
research
ISO/TC 215Environmental management
ISO/TC 28Petroleum and
petroleum productsISO/TC 180
Solar energyISO/TC 203
Technical energy
systems
ISO/TC 184Industrial
automation systems and integration
ISO/TC 172
Optics and photonics
ISO/TC150Implants for
surgery
ISO/TC 34Food
products
ISO/TC 217Cosmetics
ISO/TC 48Laboratory equipment
ISO/TC 35Paints and varnishes
NANO-PARTICLES
METROLOGY ANDCHARACTERIZATION
EXTERNAL LIAISONS
RISK/HS&E
IEC/TC 113NanotechnologyStandardization
for electricaland electronicproducts and
systems
IEC/TC 110Flat panel displays
IEC/TC 105Fuel cell
technologies
IEC/TC 86Fibre optics
IEC/TC 82Solar
photovoltaic energy systems
IEC/TC 59Performance of
household electrical
appliances
IEC/TC 48Electromechanical components and
mechanical structures for
electronic components
IEC/TC 235Primary cells and batteries
IEC/TC 34Lamps and
related equipment
IEC/TC 21Secondary cells and batteries
CURRENT AND POTENTIAL LIAISONS – IEC/TC 113
SEMI
IEEE
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
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
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
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/nanotech-workshop )
– Terminology coordination through ISO/TC 229/JWG1
– Nanotechnologies Liaison Coordination Group
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