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 www.bsigroup.com/nano

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

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

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 26000 (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

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

»…………………………………..

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 of ISO)

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.”

“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)

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

The challenges

• “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!!

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.”

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: www.nanotechproject.org/inventories/consumer )

• Critical areas:

– Coordination and harmonization across standards developers and stakeholders

– Terminology

– Measurement and characterization

– Health, safety and environmental issues

– Material specifications

International Organisation for Standardization ISO/TC 229 - Nanotechnologies

– Established in June 2005

– 44 members – 36 “P” and 8 “O” (see www.iso.org/iso/standards_development/technical_committees/list_of_iso_technical_committees/iso_technical_committee.htm?commid=381983 )

– 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

International Electrotechnical Commission IEC/TC 113 – “Nanotechnology standardization for electrical and electronic products and systems”

• Established June 2006 with US Chair and German secretariat• www.iec.ch/cgi-bin/procgi.pl/www/iecwww.p?

wwwlang=e&wwwprog=dirdet.p&progdb=db1&css_color=purple&committee=T

C&number=113

• 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

• 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'

•European Committee for Standardization CEN/TC 352 - Nanotechnologies

Published standards and work programmes – ISO, IEC and CEN

• ISO/TC 229, Published standards see:

www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_tc_browse.htm?commid=381983&published=on&includesc=true

• Work programme see:

www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_tc_browse.htm?commid=381983&development=on

• IEC/TC 113, Published standards see:

www.iec.ch/cgi-bin/procgi.pl/www/iecwww.p?wwwlang=e&wwwprog=TCpubs.p&progdb=db1&committee=TC&css_color=purple&number=113

• Work programme see:

www.iec.ch/cgi-bin/procgi.pl/www/iecwww.p?wwwlang=e&wwwprog=sea1122.p&progdb=db1&css_color=purple&class=&refno=&committee=&pubno=&header=*+(all)&search=program&pcomm=113

• CEN/TC 352, Published standards see:

www.cen.eu/CENORM/Sectors/TechnicalCommitteesWorkshops/CENTechnicalCommittees/Standards.asp?param=508478&title=CEN%2FTC+352

• Work programme see:

www.cen.eu/CENORM/Sectors/TechnicalCommitteesWorkshops/CENTechnicalCommittees/WP.asp?param=508478&title=CEN%2FTC+352

UK Publications and work programmePublicly 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 6699-1 Guide to specifying nanomaterials• PD 6699-2 Guide to safe handling and disposal of manufactured nanomaterials• PD 6699-3 Guide to assessing airborne exposure in occupational settings relevant to nanomaterialsAll documents are available for free download at www.bsigroup.com/nano except PD 6699-3

Under development: PAS 137 - Nanomaterials and nanotechnology-based products – Guidance on legislation and standards for SMEs

ISO 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

Framework and core terms

Terminology - manufacturing

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

Nanomaterials classification

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

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

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

Toxicological Screening

of Nanomaterials- cooperation with OECD

WPMN

Determining Relative Hazard Potential of Nanomaterials

Controlling Occupational Exposures to Nanomaterials

Future ScreeningFuture ScreeningTest TBDTest TBD

Support to In vivo Tox Test TBD

Support to In vitro Tox Test TBD

Metrology TBD

Terminology TBD

Workplace MonitoringWorkplace Monitoring

Metrology TBDMetrology TBD

Terminology TBDTerminology TBD

Current Practices

Safe handling guidance

2007……..8……….9………10...

Seq

uen

ce

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

Risk evaluation framework

Risk management‘control banding’

MSDS guidance

Future NWIP TBD

2007……..8……….9………10.

2010……..11…….12…..

ISO 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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WG4 – current work programme

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Guidance

Survey of Material Specification Needs

PG3 TS 12805 Guide to specifying engineered nanomaterials, UK

PG2 TS 11937-1 Nanomaterial titanium dioxide -- Part 1: General, China

PG1 TS 11931-1 Nanomaterial calicum carbonate -- Part 1: General, China

TS 11937-2 Nanomaterial titanium dioxide -- Part 2: Applications, China

Quantum dots

Carbon Nano-objects

Zinc oxide

Cadmium sulfide

ISO TC 229 WG#4

Compound nano-objects

Fuctionalized nano-objects

Gudiance on specifying metal oxide nano-objects

TS 11931-2 Nanomaterial calicum carbonate -- Part 2: Applications, China

Reference materials for toxicology Carbon nanotubes

Metallic Nano-objects

Metal Oxide Nano-objects

Nickel

Silicon dioxide

Organic

CEN/TC 352, ISO joint project entitled: Guidance on labelling of manufactured nanparticles and products containing manufactured nanoparticles. Business to business labeling is of interest to WG4. Closing date:2009-04-13.

Carbon black

1H 2008 2H 2008 1H 2009 2H 2009 1H 2010 2H 2010 1H 2011 2H 2011 1H 2012 2H 2012 1H 2013

Potential New Work Items (NWIP) are highlighted in YellowKEYISO TC229 Nanotechnologies Work Group Roadmap and Project Timelines

Completed Work Items (published internationally) are highlighted in GreyApproved Work Items In Progress are highlighted in Green

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

ISO/TC 107Metallic and

other inorganic coatings

ISO/TC 38

Textiles

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

ISO/TC 61

Plastics

Current and potential liaisons for ISO/TC 229

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 217Cosmetics

ISO/TC 34Food

products

ISO/TC 48Laboratory equipment

NANO-PARTICLES

METROLOGY ANDCHARACTERIZATION

EXTERNAL LIAISONS

RISK/HS&E

BIPM

ISO/TC 142Cleaning

equipment for air and

other gases

ISO/TC 59

Building construction

ISO/TC 35Paints and varnishes

ISO/TC 45Rubber and

rubber products

• 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.

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 www.bsigroup.com/nano