Progress towards standardization for nanotechnologies.ppt by liningnvp

VIEWS: 6 PAGES: 26

									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
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 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
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 Standards
 Process accommodates special needs
                                NWIP from member organisation


               External                ISO TC/SC process
               process                                           Approval – at least 5 P members
                                              NP
                                                                 agree to participate and >50% of
                                                WD               members voting are in favour
First level of
                                            Final WD
consensus
                Text
(amongst experts)                    First CD             Published as       ISO/PAS

                                     Final CD

                   Text       DIS                 Published as      ISO/TS
Second level
of consensus
(amongst
               {              FDIS
                                                                   Also ISO/TR
members of                International                           for informative
ISO)                        Standard                                documents
                                          ISO Workshop

                                                IWA
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
                >$500 Billion but <$3 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)
      The challenges

    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.”

•     “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!!
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
   – 40 members – 33 “P” and 7 “O” (see
     www.iso.org/iso/standards_development/technical_comm
     ittees/list_of_iso_technical_committees/iso_technical_co
     mmittee.htm?commid=381983 )
   – 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
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=e&wwwprog=dirdet.p&progdb=db1&cs
     s_color=purple&committee=TC&number=113
 •   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
•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'
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&pu
    blished=on&includesc=true
•   Work programme see:
    www.iso.org/iso/iso_catalogue/catalogue_tc/catalogue_tc_browse.htm?commid=381983&de
    velopment=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=T
    C&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=p
    urple&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 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
ISO TC 229 – Horizontal activities 1



        Terminology and Nomenclature (JWG 1)
             “what you call it” - Convened by Canada
    ISO/TC 229 JWG1: Strategic Roadmap
                                      Framework and
                       Base           core terms
                                                                                    Nano films         Nano
                     Definitions                         Terminology –carbon                        dispersions
                                     Nomenclature        nanostructures
                                     model
    Nano-
                                                                Terminology -
  processes                                                                         Nanomaterials classification
                                                                nanoparticles

Terminology –                                                     Nanoscale
                                                                   objects                Nanostructured
nano-bio interface
                                                                                            materials
                         Nanotechnologies                         Nanomaterials           Terminology -
    Nano-                                                                                 nanomaterials
  production                                                    Complex
                                                                                          Terminology -
                                                               assemblies
                                                                                          nanostructures
 Terminology -
 manufacturing

                                                          Nanomedical
                                                                                                 Nanosensors
                                                            devices

                     Nanomeasurement                  Terminology –             Devices and
                                                      medical and
                                                                                applications
                           Nanomeasurement            consumer
      Nanometrology
                                tools                                                          Nanoelectronic
                                                            Nanophotonic                          devices
                     Terminology – nanoscale                  devices
                     measurement                                                           (IEC) Vocabulary -
                                                           (IEC) Terminology –
                                                           nano-optics                     electrotechnical
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
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           Basic Character set
                      Purity, Composition, Geometrical property, Sampling method.
nanoparticles
                                    Advanced Character set
                                      Elemental structure, Chemical functionality,
                                      Electrical, Magnetic, Mechanical , Optical properties
Coatings/                      Basic Character set
Nanostructured materials       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
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
                       ISO/TC 229 WG3 : Strategic Roadmap
                         Standard Methods for Controlling       Standard Methods for Determining         Standard Methods for
                            Occupational Exposures to           Relative Toxicity/Hazard Potential           Toxicological
                                  Nanomaterials                         of Nanomaterials
                                                                                                              Screening
                                                                                                           of Nanomaterials




                                                                    Future NWIP TBD
                                                                                                          Future Screening
                                                                    Nanoparticle                              Test TBD
                                                                  Inhalation Testing
                       Future Occupational
                         Standards TBD                            Nanoparticle
Sequence




                                                                 Toxicity Testing                       In vivo Tox Test TBD
                         Current
                                                             Physico-Chemical
                       Practices TR
                                                              characterization                       In vitro Tox Test TBD
                  Workplace Monitoring                      Endotoxin Test
                                                                                                     Metrology TBD
                  Metrology TBD                     Metrology TBD
                                                                                               Terminology TBD
           Terminology TBD                  Terminology TBD

           2008                              2009                                    2010                             2011
ISO TC 229 – Structure/working areas




                                                                              PRODUCT AND PROCESS (sc)




                                                                                                         PRODUCT AND PROCESS (sc)
                                Material Specifications (WG4)




                                                                                                                                    voluntary governance structures
                                                                                                                                    Support for “REGULATION” and
        Terminology and Nomenclature (JWG 1)
                                                          “what you call it” - Convened by Canada
          (Convened by China)




       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
      WG4 – current work programme

                                                                                                                                            Completed Work Items (published internationally) are highlighted in
             ISO TC229 Nanotechnologies Work Group Roadmap and Project Timelines                                                     KEY    Approved Work Items In Progress are highlighted in Green
                                                                                                                                            Potential New Work Items (NWIP) are highlighted in Yellow
          1H 2008                     2H 2008                     1H 2009                 2H 2009                1H 2010            2H 2010 1H 2011 2H 2011 1H 2012 2H 2012 1H 2013
ISO TC 229 WG#4
  Metallic Nano-objects
                                                                                                                                                         Nickel
  Metal Oxide Nano-objects
  PG2 TS 11937-1 Nanomaterial titanium dioxide -- Part 1: General, China
                                                          TS 11937-2 Nanomaterial titanium dioxide -- Part 2: Applications, China
                                                                                                                                            Zinc oxide
                                                                                                                                                                                              Silicon dioxide
  Compound nano-objects
  PG1 TS 11931-1 Nanomaterial calicum carbonate -- Part 1: General, China
                                                        TS 11931-2 Nanomaterial calicum carbonate -- Part 2: Applications, China
                                                                                                                                                                                 Cadmium sulfide
  Fuctionalized nano-objects
                                                                                                                                            Quantum dots
                                                                                                                                                                     Organic
  Carbon Nano-objects
                                                                                                                                Reference materials for toxicology
                                                                                                                                           Carbon nanotubes
                                                                                                                                           Carbon black
  Guidance
                              PG3 TS 12805 Guide to specifying engineered nanomaterials, UK
                                                          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.
                                                                                                                                            Gudiance on specifying metal oxide nano-objects
  Survey of Material Specification Needs
                                                                                                                    ?
  Other TC 229 structures

• Chairman’s 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
                                    Current and potential liaisons for ISO/TC 229
                                                                     ISO/TC 122       ISO/TC 206       ISO/TC 217
                                                      ISO/TC 119
                                                                     Packaging          Fine           Cosmetics        ISO/TC 84
                                                       Powder                         ceramics                         Devices for
MATERIALS                          ISO/TC 107
                                  Metallic and
                                                      metallurgy                                                     administration of            BIOMEDICAL
                                                                                                                     medical products
                                      other                                                                          and intravascular
                      ISO/TC 91     inorganic                                                                            catheters      ISO/TC150
                    Surface active coatings                                                                                            Implants for
                        agents                                                                                                            surgery
              ISO/TC 142
                Cleaning
               equipment                                              BIPM                                                                         ISO/TC 168
               for air and                                                                                                                         Prosthetics
              other gases                                                                                                                         and orthotics

      ISO/TC 61
      Plastics                                                       EXTERNAL
                                                                                              RISK/HS&E                                                     ISO/TC 212
                                                                     LIAISONS                                                                                  Clinical
  ISO/TC 59                                                                                                                                                  laboratory
                                                                                                                                                          testing and in
  Building                                                                                                                                               vitro diagnostic
construction                                                                                                                                               test systems


 ISO/TC 45                                                                                                                                                 ISO/TC 215
Rubber and                                                                                                                                                    Health
   rubber                                                    NANO-
                                                                                                                                                           Informatics
  products                                                 PARTICLES
                                                                                   METROLOGY AND
        ISO/TC 38
                                                                                  CHARACTERIZATION
         Textiles                                                                                                                                 ISO/TC 225
                                                                                                                                                    Market
              ISO/TC 35                                                                                                                           opinion and
              Paints and                                                                                                                             social
              varnishes                                                                                                                            research
                             ISO/TC 34                                                                                                  ISO/TC 215
                                Food                                                                                                  Environmental
                              products                                                                                                 management

                                         ISO/TC 48                                                                          ISO/TC 28
                                         Laboratory                                                                       Petroleum and
                                         equipment                                                                          petroleum
                                                        ISO/TC 172                                                           products
                                                                        ISO/TC 184                          ISO/TC 180
                                                        Optics and                         ISO/TC 203
                                                                         Industrial                        Solar energy
                                                        photonics       automation         Technical
                                                                       systems and           energy
                                                                        integration         systems
                                                                                                                           ENERGY
    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
• 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.

								
To top