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

Seq

uen

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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”

– Convened by USA

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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