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
Jan 15, 2015
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
Ma
teria
l Sp
ecifica
tion
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G4
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vened
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PR
OD
UC
T A
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PR
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PR
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r “RE
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d
volu
ntary g
overn
ance stru
ctures
WG4 – current work programme
?
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