An introduction to standards and standardization for nanotechnologies

1
An introduction to standards and standardization
for nanotechnologies

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

2
Overview

• Why standards for nanotechnologies are important
• Standards and standardization
• Why is nanotechnology important?
• What needs standardizing and why?
• Current standardization committees
• Existing standards, standardization projects and
  proposals
• Pre- and co-normative research to support future
  needs
• Support for possible regulation

3
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

4
Standards

• Standards can be of two types
• Metrological standards length, mass, time,
  quantity of matter primary and secondary
  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
  management ISO 9001 and ISO 14000
• Reporting things as in e.g. proposed ISO 26000
  (Social Responsibility)
• To
• support commercialisation and market development
• 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.

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, electrical sockets and plugs, steel
  specifications,..
• Virtually invisible to the man in the street
  there are over 15,000 International Standards,
  many with multiple parts
• But are absolutely critical to our modern way of
  life covering things such as CDs/DVDs, internet
  protocols, credit cards, pin numbers, quality and
  environmental management,.

6
and 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,
• CEN, CENELEC, ETSI..
• ISO, IEC ITU
• INFORMAL developed by a SDO (Standards
  Development Organisation)
• ASTM, IEEE, SAE, SEMI, VDI(gt600 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
• Based on CONSENSUS (i.e. no sustained opposition)
  not necessarily unanimity.

7
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.

8
Extent of ISO System
151 full-time posts
More than 14 941 ISO Standards
Secretary
Chairman
734 Secretariats held by 37 countries
About 190 TCs
Ch
C
E
544 SCs
Convenor
C
Standardization projects
2 188 WGs
4 176 active projects (30 June 2005)
9
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 in favour
Also ISO/TR for informative documents
10
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)
11
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!!

12
Needs for standardization

• To support commercialisation and market
  development
• To provide a basis for procurement
  technical/quality/environmental management
• 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
• But 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)
• Hence there is a need for a dedicated committee
  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.

13
A brief history of standardization for
nanotechnologies

• 12/03 - China establishes United Working Group
  for Nanomaterials standardization
• - UK proposes CEN/BTWG to develop strategy for
  European standardization in nanotechnologies.
• 03/04 Proposal for CEN/BTWG approved UK
  awarded secretariat
• 05/04 UK establishes NTI/1 national committee
• 08/04 ANSI forms Nanotech Standards Panel in
  response to a request from OSTP
• 10/04 UK starts work on PAS 71 - vocabulary for
  nanoparticles
• 11/04 Japan establishes study group for
  nanotech. standardization
• 12/04 China publishes 7 national nanotech
  standards
• 01/05 UK submits proposal for an ISO committee
• 04/05 - China implements published nanotech
  standards
• - ASTM International approves establishment
  of E56 committee
• - ISO ballot on UK proposal approved 30
  votes to nil

14

• 06/05 - ISO confirms establishment of TC 229
  UK secretariat chair.
• - UK publishes PAS 71, vocabulary
  nanoparticles (free from www)
• - CEN/BT/WG 166 delivers European strategy to
  CEN/BT
• 11/05 - Inaugural meeting of ISO TC 229 in
  London.
• - CEN establishes CEN/TC 352
  Nanotechnologies UK Chair Secretariat
• 01/06 UK submits first NWIP to TC 229
  vocabulary for nanoparticles
• 03/06 IEC receives proposal for new TC for
  Nanotechnologies
• 04/06 First meeting of CEN/TC 352 (agreed to
  collaborate closely with ISO/TC 229)
• 05/06 IEC agrees to establish TC 113 in the
  field of nanotechnologies issue of
  coordination with ISO/TC 229
• 06/06 2nd meeting of ISO/TC 229, Tokyo
• 12/06 3rd meeting of ISO/TC 229, Seoul
• 06/07 4th meeting of ISO/TC 229, Berlin
• 12/07 5th meeting of ISO/TC 229, Singapore
  (jointly with IEC/TC 113)
• To date national committees established in
  Australia, Canada, China,
• France, Germany, India, Iran, Italy, Japan,
  Korea, Russia, Singapore,
• Thailand, UK, US,

15
UK NTI/1 Committee (as of September 2006)

• Established May 2004 - second (after China)
  national committee to be formed
• Develops national standards and other
  standardization documents 1 published Publicly
  Available Specification (PAS) PAS 71
  vocabulary nanoparticles currently preparing 2
  Published Documents (Guide to safe handling and
  disposal of nanoparticles and Guide to
  specification of nanomaterials) and 7 PASs (Guide
  to labelling, Terminologies for medical, health
  and personal care applications of
  nanotechnologies, nanomaterials, carbon
  nanostructures, nanofabrication, measurement
  terms, and the bio-nano interface).
• Provides UK input to international committees
  ISO/TC 229, IEC/TC 113 and CEN/TC 352
• Meets four times per year
• Members represent key stakeholders from Defra,
  DTI, EA, FSA, HSE,HSL, IOM, ION, IoP, RSC, Durham
  University, NIA, CERAM, Qinetiq, .
• For further details contact the secretary Ms Anne
  Cassidy anne.cassidy_at_bsi-global.com or see
• www.bsi-global.com/nanotechnologies

16
European Committee for Standardization
committee CEN/TC 352 - Nanotechnologies

• 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 New projects
• Format for reporting the engineered nanomaterials
  content of products (to be published as a
  CEN/TS)
• Guide to nanoparticle measurement methods and
  their limitations (CEN/TR)
• Guide to methods for nano-tribology measurements
  (CEN/TR).

17
International Organisation for Standardization
committee ISO/TC 229 - Nanotechnologies

• Established in June 2005 with UK Chair and
  Secretariat
• 37 members 29 P and 8 O (see
  http//www.iso.org/iso/en/stdsdevelopment/tc/tclis
  t/TechnicalCommitteeList.TechnicalCommitteeList)
• Liaisons with 15 other ISO TCs and 6 external
  bodies IEC/TC 113, CEN/TC 352, Asia Nano Forum,
  EC JRC, OECD and VAMAS
• Exploring additional external liaisons for
  emerging economies

18
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
• 26 members - 15 P and 11 O
• First meeting March 2007
• 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

19
ISO TC 229 adopted Scope

• Standardization in the field of nanotechnologies
  that includes either or
• both of the following
• Understanding and control of matter and processes
  at the nanoscale, typically, but not exclusively,
  below 100 nanometres in one or more dimensions
  where the onset of size-dependent phenomena
  usually enables novel applications
• Utilizing the properties of nanoscale materials
  that differ from the properties of individual
  atoms, molecules, and bulk matter, to create
  improved materials, devices, and systems that
  exploit these new properties
• Specific tasks include developing standards for
• terminology and nomenclature metrology and
  instrumentation, including
• specifications for reference materials test
  methodologies modelling and
• simulation and science-based health, safety, and
  environmental
• practices.
• Note Scope is further defined by the TCs
  Strategy Statement

20
TC 229 Structure/working areas
SUPPORT FOR REGULATION
PRODUCT AND PROCESS (sc)
PRODUCT AND PROCESS (sc)
PRODUCT AND PROCESS (sc)
Terminology and Nomenclature (WG 1) what you
call it - Convened by Canada
Measurement and Characterization (WG 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
21
TC 229 Work programme

• Currently work items
• Terminology for nanoparticles for publication
  as an ISO/TS (WG 1)
• Health and safety practices in occupational
  settings relevant to nanotechnologies for
  publication as an ISO/TR (WG 3)
• Endotoxin test on nanomaterial samples for in
  vitro systems for publication as an
  International Standard (WG 3)
• New projects
• The Use of Transmission Electron Microscopy in
  the Characterization of Single-walled Carbon
  Nanotubes
• The use of Scanning Electron Microscopy (SEM) and
  Energy Dispersive X-ray Analysis (EDXA) of Single
  Wall Carbon Nanotubes (SWCNTs)
• Technical Specification for the Use of UV-Vis-NIR
  absorption spectroscopy in the Characterization
  of Single-Walled Carbon Nanotubes (SWCNTs)
• Technical Specification for the use of
  NIR-Photoluminescence (NIR-PL) Spectroscopy in
  the Characterization of Single-Walled Carbon
  Nanotubes (SWCNTs)
• Generation of silver nanoparticles for inhalation
  toxicity testing
• Monitoring of silver nanoparticles in inhalation
  exposure chambers for inhalation toxicity testing

22
TC 229 Work programme - 2

• New Work Item Proposals
• Terminology and nomenclature for nanotechnologies
  Framework and core terms
• Use of Thermo Gravimetric Analysis (TGA) in the
  purity evaluation of Single Walled Carbon
  Nanotubes (SWCNT)
• Use of Evolved Gas Analysis-Gas Chromatograph
  Mass Spectrometry (EGA-GCMS) in the
  Characterization of Single-Walled Carbon
  Nanotubes (SWCNTs)
• In December 2007 ISO/TC 229 completed its first
  survey of
• Standardization needs which identified 110 high
  priority topics, of
• which
• 2 were relevant to WG 1,
• 54 were relevant to WG 2,
• 31 were relevant to WG 3,
• 5 were relevant to a new WG on materials
  specifications, and
• 18 were relevant to other Technical Committees.
• These results will form the basis of a Road Map
  for the future work
• of the committee.

23
Current and potential liaisons for ISO/TC 229
BIOMEDICAL
MATERIALS
EXTERNAL LIAISONS
RISK/HSE
NANO-PARTICLES
METROLOGY AND CHARACTERIZATION
ISO/TC 48 Laboratory equipment
ENERGY
Version 4, Mar 2007
24
Current nanotechnology standards

• Only National standards to date
• China 12 National standards published and
  adopted
• Terminology
• GB/T19619-2004 Terminology for nanomaterials
• Sizing
• GB/T13221-2004 Nanometer powder - Determination
  of particle size distribution - Small angle X-ray
  scattering method (ISO/TS13762)
• GB/T19587-2004 Determination of the specific
  surface area of solids by gas absorption using
  the BET method (ISO 92771999)
• GB/T19627-2005 Particle size analysis - Photon
  correlation spectroscopy (ISO 133211996)
• GB/T 15445.2-2006 Representation of results of
  particle size analysisPart 2Calculation of
  average particle sizes/diameters and moments from
  particle size distributions(ISO 9276-22001,IDT)
• GB/T 15445.4-2006 Representation of results of
  particle size analysisPart 2Characterization of
  a classification process(ISO 9276-42001,IDT)
• GB/T 20307-2006 General rules for nanometer-scale
  length measurement by SEM
• GB/T 20099-2006 Sample preparation dispersing
  procedures for powders in liquids
• Nano-material specificiations
• GB/T19588-2004 Nano-nickel power
• GB/T19589-2004 Nano-zinc oxide
• GB/T19590-2004 Nano-calcium carbonate
• GB/T19591-2004 Nano-titanium dioxide
• UK PAS 71 2005 Vocabulary Nanoparticles
• Several standards (International, regional and
  national) that also apply to the nanoscale

25
Terminology and nomenclature for nanotechnologies

• One current document specific to nanoparticles
• UK PAS 71 - available for free download at
• http//www.bsi-global.com/Manufacturing/Nano/Downl
  oad.xalter
• For fullerenes (nanoparticles or molecular
  structures???), there is a provisional
  nomenclature developed by IUPAC -
  http//www.chem.qmul.ac.uk/iupac/fullerene/r3
• Chinese National standard for nanomaterials
• GB/T19619-2004 Terminology for nanomaterials
• ASTM E56 has published a terminology for
  nanotechnology
• E2456-06 Terminology for Nanotechnology
• Approach recommended by UK
• Develop series of terminologies/vocabularies in
  various topic areas, which together will form a
  terminology for nanotechnologies. This will
• allow consensus to be achieved more easily,
  allowing earlier publication
• enable changes in one topic area to be
  implemented without altering a substantial
  document
• allow documents to be developed in tandem with
  technology developments rather than trying to
  shoe horn a new technology into an existing
  terminology
• ISO TC 229 Work Item Terminology and definitions
  for nanoparticles approved April 2006.

26
Current UK (NTI/1) Work Items

• 6 sector specific terminologies
• Medical, health and personal care applications of
  nanotechnology
• The bio-nano interface
• Carbon nanostructures
• Nanomaterials
• Nanofabrication
• Common nanoscale measurement terms including
  instrumentation
• 3 guides
• Guide to labelling of manufactured nanoparticles
  and products containing manufactured
  nanoparticles
• Guide to safe handling and disposal of
  manufactured nanomaterials
• Guide to specifying nanomaterials
• All documents will be published by the end of
  2007 and will be made
• freely available on the www see
  www.bsi-global.com/nanotechnologies

27
Do we need a nomenclature for nanoparticles
(nanomaterials)?

• a structured naming system that can allocate
  unique names to unique entities, which allows
  as-yet undiscovered entities to be similarly
  named, and which ideally allows the nature of all
  such entities to be determined from their name
• needs to provide recognisable added value in
  comparison to existing descriptions, without
  being so complex as to make it unusable
• must take account of range and complexity of
  nanoparticles / nanomaterials under
  consideration
• Perhaps easier to agree an ordered structure for
  describing nanoparticles containing e.g.
• core composition and crystal structure
• composition of any deliberately applied surface
  layers
• any surface functionalization
• specific surface area
• particle shape descriptor
• and particle size distribution.

28
Pre- and co-normative research requirements

• Critical areas are risk/regulation
• Development and delivery needed of
• test methods to detect and identify
  nanoparticles, and to characterize nanoscale
  materials and devices.
• protocols for bio- and eco-toxicity testing,
  including protocols to evaluate effects of short
  term and long term dermal, nasal, oral and
  pulmonary exposure to, elimination of, and fate
  determination for nanomaterials and nanoscale
  devices. Work in these areas being undertaken by
  SnIRC, INOS, ECVAM, CRM, EPA/NIOSH, Rice
  University, Nanosafe2, NANOTOX, etc.
• protocols for whole life cycle assessment of
  nanoscale materials, devices and products.
• risk assessment tools relevant to the field of
  nanotechnologies.
• protocols for containment, trapping and
  destruction of nanoparticles and nanoscale
  entities.
• occupational health protocols relevant to
  nanotechnologies, in particular for industries
  dealing with nanoparticles and nanoscale devices.
  
• Collaboration with OECD Working Party for
  Manufactured Nanomaterials

29
Nanomaterial test methods needed for risk
assessment/to support possible regulation

• Particle detection and measurement
• Fast, accurate methods for particle size
  measurement in air, water, food and the
  environment
• Specific Surface Area (SSA)
• Particle size distribution
• Shape factor
• Particulate density/Exposure
• Work relevant to ISO TC 24 SC4 - Sieves, sieving
  and other sizing methods Particle
  Characterisation, Size, Surface area and Zeta
  potential
• Identification of composition and surface
  functionalities, including any catalytic and
  enzymatic characteristics
• bulk or individual particle measurements?
• Work relevant to ISO TC 201 Surface Chemical
  Analysis and
• ISO TC 202 microbeam analysis

30
Other ISO TCs with an interest in the area of
risk and health effects of nanotechnologies

• 34 - Food and food products
• 94 - Personal safety protective equipment
• 122 - Packaging
• 146 - Air quality (New TR published 2007
  Workplace Atmospheres - Ultrafine, nanoparticle
  and nano-structured aerosols - Inhalation
  exposure characterization and assessment)
• 147 - Water quality
• 150 - Implants for surgery
• 194 - Biological evaluation of medical devices
• 207/SC 5 - Environmental management life cycle
  assessment
• 217- Cosmetics
• TMB Working Group on Risk Management (Risk
  Terminology defined in ISO/IEC Guides 51 73)

31
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.