Standardization in support of safe and successful nanotechnologies

Dr Peter Hatto,Director of Research, IonBond LtdChairman ISO TC 229, CEN TC 352 and BSI NTI/1 Nanotechnologies standardization committees

2nd Annual Nanotechnology Safety for Success Dialogue WorkshopBrussels

2 – 3 October 2008

Overview

Standards and standardization Role of standards Standardization organisations Development of formal standards

Standardization for nanotechnologies What needs standardizing and why? Current standardization committees Existing standards, standardization projects and proposals Cooperation, coordination and harmonization

StandardsStandards can be of two types: Metrological standards Written standardsWritten 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.Standards are based on CONSENSUS not necessarily unanimity

Standards

Standards are: Ubiquitous – covering such things as shoe sizes, nuts and bolts, petrol

grades, warning signs, pipes and fittings, fire extinguishers, gas cylinders, 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;

Are absolutely critical to our modern way of life – covering things such as: internet protocols, CDs/DVDs, credit cards, pin numbers, quality and environmental management, carbon trading, space vehicles …………………………………..

and standardizationStandards 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.

International Organization for Standardization (ISO)Paraphrasing the French philosopher Chamfort: “It is easier tolegislate than to legitimise” INTERNATIONAL STANDARDS PROVIDE LEGITIMACY:Standards are:

Proposed, commented on and approved by members of the international community

Developed by experts nominated by members Process is based on well established principle of CONSENSUS Voluntary

Standards provide critical elements of Governance through ISO 9001, 14001 (and ISO 26,000 – expected to be published in 2010).

ISO structure includes committees on CERTIFICATION AND ASSESSMENT (CASCO), CONSUMER POLICY (COPOLCO), DEVELOPING COUNTRIES (DEVCO) REFERENCE MATERIALS (REMCO)

Extent of ISO System~150 full-time posts~150 full-time posts More than 16,500More than 16,500

ISO StandardsISO Standards

~750 Secretariats~750 Secretariatsheld bheld byy

~40 countries~40 countries>200 TCs>200 TCs

>>540 SCs540 SCs

>2>2 250 WGs250 WGs

~~ 3,500 active projects3,500 active projects

Ch

CConvenor

Secretary Chairman

E E

EE

WGE

C

Standardization projects

Standardization projects

Development of International StandardsDevelopment of International StandardsProcess accommodates special needsProcess accommodates special needs

NWIP from member organisation

Also ISO/TRfor informative

documents

Approval – at least 5 P members agree to participate and >50% of members voting are in favour

ISO TC/SC processISO TC/SC processExternalExternalprocessprocess

NP

WD

Final WD

Text First CD Published as ISO/PASISO/PAS

Final CD

DISText Published as ISO/TSISO/TS

FDIS

InternationalInternationalStandardStandard

ISO Workshop

IWA

First level of consensus(amongst experts)

{Second level of consensus (amongst members)

Major issues for nano

Diversity of disciplines impacted by and contributing to nanotechnologies

Global impact Rapid 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 Material specifications

International Organisation for Standardization committee ISO/TC 229 - Nanotechnologies

Established in June 2005 40 members – 32 “P” and 8 “O” (see

http://www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=381983 )

Liaisons with 16 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 other groups (e.g. International Alliance for NanoEHS Harmonization) and for emerging economies

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

• Work Item: GUIDE FOR CARBON NANOTUBE SPECIFICATION FOR ELECTROTECHNICAL APPLICATION

TC 229 – Horizontal activities 1

Terminology and Nomenclature (JWG 1)“what you call it” - Convened by Canada

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

Nanomaterials classification

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

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 – 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

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

Sequ

ence

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

Material Specifications (W

G4)

(Convened by C

hina)

PRO

DU

CT A

ND

PRO

CESS (sc)

PRO

DU

CT A

ND

PRO

CESS (sc)

Support for “REG

ULA

TION

” and voluntary governance structures

TC 229 Current work programme – JWG1 at 01.10.08 ISO/TS 27687: Terminology and definitions for nano-object – nanoparticle,

nanofibre and nanoplate, published August 2008 Under development:

ISO/TR: Terminology and nomenclature for nanotechnologies — Framework and core terms

ISO/TS: Terminology and definitions for carbon nanomaterials ISO/TS: Core Terms - Terminology and Definitions ISO/TS: Terminology and definitions for nanostructured materials 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

Committee resource document: Outline of Nanomaterials classification ("Nano tree")

New work item proposals: ISO/TS: Terminology for nanomanufacturing

TG on “Nomenclature model for nanomaterials”

TC 229 Work programme at 01.10.08 – JWG2 (SWCNT work) 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.

JWG2 – MWCNT and other work at 01.10.08

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/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

TC 229 Work programme – WG3 at 1.10.08

ISO/TR 12885 - Safe Practices in Occupational Settings Relevant to Nanotechnologies - to be published early November

DIS stage 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 Under development:

ISO/TR Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment.

Guide to safe handling and disposal of manufactured nanomaterials New proposal for a “nanomaterial risk evaluation framework” expected

shortly

TC 229 Work programme – Materials specifications (WG4)

• ISO/TS: Materials specification for nano-titanium dioxide

• ISO/TS: Materials specification for nano-calcium carbonate• ISO/TS: Guide to specifying manufactured nano-materials

Other TC 229 structures

Chairman’s Advisory GroupTask Groups on:

Planning and Coordination; Business Planning; Material Specifications; Nanotechnologies and Sustainability

Nanotechnologies Liaison Coordination GroupJWG2 study groups on:

metrology strategy

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 AND

CHARACTERIZATION

EXTERNAL LIAISONS RISK/HS&E

European Committee for Standardization committee CEN/TC 352 - Nanotechnologies

Established November 2005 All 30 members of CEN are notionally members – around 12 active ones 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. Awaiting a Commission response to M409 “elaboration of a programme of

standards to take into account the specific properties of nanotechnology and nanomaterials” submitted in May 2008.

Currently 3 projects: Guide to nanoparticle measurement methods and their limitations (CEN/TR) Guide to methods for nano-tribology measurements (CEN/TR) Guide to labelling of manufactured nanoparticles and products containing

manufactured nanoparticles Undertaking an active review of relevant FP6 and FP7 RTD projects for possible

standardization outputs: e.g. 17 potential standardization projects identified outputs of Nanosafe2

Why standards for nanotechnologies are important

Standards will help to ensure that nanotechnology is developed andcommercialised 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 nanotechnologiesThis will be achieved 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

Thank you!

This paper was produced for a meeting organized by Health & Consumer Protection DG and represents the views of its author on thesubject. These views have not been adopted or in any way approved by the Commission and should not be relied upon as a statement of the Commission's or Health & Consumer Protection DG's views. The European Commission does not guarantee the accuracy of the dataincluded in this paper, nor does it accept responsibility for any use made thereof.