An introduction to standards and standardization for nanotechnologies

1
An introduction to standards and standardization
for nanotechnologies

• Dr Peter Hatto,
• Chairman UK NTI/1, CEN TC 352 and ISO TC 229
  Nanotechnologies Standardization committees

2
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

3
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

4
Standards

• Two types of standards
• Metrological standards
• Written 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.

5
Standards

• 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
• ..

6
NWIP from member organisation
Development of International Standards Process
accommodates special needs
Approval at least 5 P members agree to
participate and gt50 of members voting are in
favour
First level of consensus (amongst experts)
Also ISO/TR for informative documents
7
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.
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 gt500 Billion but lt3 trillion
by 2015
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)
8
The challenges
The Interagency Working Group on Nanotechnology
workshop in 1999 concluded while recognizing
nanotechnologys 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.

• 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 dont forget safety and consumer acceptance!!

9
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

10
International Organisation for Standardization
ISO/TC 229 - Nanotechnologies

• Established in June 2005
• 40 members 33 P and 7 O (see
  www.iso.org/iso/standards_development/technical_co
  mmittees/list_of_iso_technical_committees/iso_tech
  nical_committee.htm?commid381983 )
• Works closely with IEC/TC 113 and CEN/TC 352
• Liaisons with 16 other ISO TCs and 8 external
  bodies IEC/TC 113, CEN/TCs 137 and 352, Asia
  Nano Forum, BIPM, EC JRC, OECD and VAMAS
• Exploring additional external liaisons with other
  groups, e.g. International Alliance for NanoEHS
  Harmonization, NanoAf-Net, and with emerging
  economies

11
International Electrotechnical Commission EC/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
  ewwwprogdirdet.pprogdbdb1css_colorpurplecom
  mitteeTCnumber113
• 29 members - 15 P and 14 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

12

• European Committee for Standardization CEN/TC 352
  - Nanotechnologies

• Established November 2005 following a
  recommendation from CEN/BTWG 166
• UK chair and 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.
• 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.
• Two working groups established in September 2008
• WG 1 'Measurement, characterization and
  performance evaluation'
• WG 2 'Commercial and other stakeholder aspects'

13
Published standards and work programmes ISO,
IEC and CEN

• ISO TC 229, Published standards see
• www.iso.org/iso/iso_catalogue/catalogue_tc/catalo
  gue_tc_browse.htm?commid381983publishedoninclu
  desctrue
• Work programme see
• www.iso.org/iso/iso_catalogue/catalogue_tc/catalo
  gue_tc_browse.htm?commid381983developmenton
• IEC TC 113, Published standards see
• www.iec.ch/cgi-bin/procgi.pl/www/iecwww.p?wwwlang
  ewwwprogTCpubs.pprogdbdb1committeeTCcss_co
  lorpurplenumber113
• Work programme see
• www.iec.ch/cgi-bin/procgi.pl/www/iecwww.p?wwwlang
  ewwwprogsea1122.pprogdbdb1css_colorpurplec
  lassrefnocommitteepubnoheader(all)sear
  chprogrampcomm113
• CEN TC 352, Published standards see
• www.cen.eu/CENORM/Sectors/TechnicalCommitteesWork
  shops/CENTechnicalCommittees/Standards.asp?param5
  08478titleCEN2FTC352
• Work programme see
• www.cen.eu/CENORM/Sectors/TechnicalCommitteesWork
  shops/CENTechnicalCommittees/WP.asp?param508478t
  itleCEN2FTC352

14
UK Publications to date

• Publicly Available Specifications (PAS)
• PAS 71 Vocabulary Nanoparticles
• PAS 130 Guidance on the labelling of
  manufactured nanoparticles
• and products containing manufactured
  nanoparticles
• PAS 131 Terminology for medical, health and
  personal care
• applications of nanotechnologiies
• 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
• Published Documents (PD)
• PD 6699-1 Guide to specifying nanomaterials
• PD 6699-2 Guide to safe handling and disposal of
  manufactured
• nanomaterials
• All of these are available for free download at
  www.bsigroup.com/nano

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ISO TC 229 Horizontal activities 1
Terminology and Nomenclature (JWG 1) what you
call it - Convened by Canada
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ISO/TC 229 JWG1 Strategic Roadmap
Framework and core terms
Base Definitions
Nano films
Nano dispersions
Terminology carbon nanostructures
Nomenclature model
Nano-processes
Terminology - nanoparticles
Nanomaterials classification
Nanoscale objects
Terminology nano-bio interface
Nanostructured materials
Nanotechnologies
Nanomaterials
Terminology - nanomaterials
Nano-production
Complex assemblies
Terminology - nanostructures
Terminology - manufacturing
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
17
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
18
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
19
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
20
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
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ISO 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
22
WG4 current work programme
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Other TC 229 structures

• Chairmans Advisory Group
• Task Groups on
• Planning and Coordination
• Business Planning
• Material Specifications
• Nanotechnologies and Sustainability
• Societal and Consumer Dimensions of
  Nanotechnologies.
• Nanotechnologies Liaison Coordination Group
  (NLCG)
• JWG1 Task Group on nanomaterials classification
• JWG2 Study Groups on
• metrology
• Strategy
• JWG2/WG3 Task Group on measurement and
  characterization for EHS issues relevant to
  nanomaterials

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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

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• 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.