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What is Standardization?
Standardization in Nanotechnologies
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?what is
standardizationNorbert Siegel
DIN Deutsches Institut für NormungR&D Phase Standardization Group
Berlin October 30th, 2009
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DIN is a registered non-profit association supported by the private sector.
On the basis of a contractual agreement with the Federal Republic of Germany, DIN is the responsible German standards body in European and international standards work.
DIN German Institute for Standardization
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2008 2007
DIN Standards (total) 31.021 30.716
External experts 28.443*25.924
Members of DIN 1.782 1.711
DIN budget (EUR millions) 62 67
DIN employees 301 304
DIN – the figures
* Including 2.018 experts in working groups of DKE (without: 26.425)
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International and objective discourse among scientists would not be possible without a shared system of physical, chemical, mathematical and technical units (DIN 1301 ff.).The standardized international system of units (SI) provides a globally recognized basis for communication.
Example System of units
Standards help global communication
Quelle: DIN, NA Technische Grundlagen
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Carmakers Volkswagen were instrumental in developing a system for securing child car seats which meets the safety requirements needed in vehicles today.
The company's own research played an exemplary role in the development of International Standard ISO 13216-1 (now known as the "ISOfix-System").
Standards give consumers more security
Example ISOfix system
Quelle: „Gut in Norm“, VOLKSWAGEN magazin 1/2000, S. 82-85
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All users of the Internet and mobile PCs appreciate the advantages of highly compressed image files, which provide a maximum of information via a limited band width.
Compared with the classic JPEG (Joint Photo-graphic Expert Group), the new Standard JPEG2000 (ISO/IEC FCD 15444-1) is considerably more efficient.
Standards create a basis for innovation
Example JPEG 2000
Quelle: DIN-Preis 2001, Nutzen der Normung
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R&D phase standardization - Goals:
To identify appropriate areas for standardization at an early stage
To promote the transfer of knowledge and technology from research to standardization and vice versa
To increase the involvement of SMEs and scientific research in standardization processes
To firmly embed the concept of norms and standards in public research programmes
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Example: Nanotechnology
Measurement and test standards (including terminology)
Terminological definitions facilitate communication and cooperation in nanotechnology and nanotechnology research
Agreements on new methods of measurement and testing are essential for scientific progress in nanotechnology research
Quality and safety standards
A means to protect users and consumers and raise acceptance levels, with a positive impact on market growth and a desirable knock-on effect for research
The role of standards in research
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Development of a DIN standard
Standards proposal
Draft standard
Comments
DIN-Standard
Industry
Research
Consumers
Professional
organizations
Public authorities
Trade associations
The trades
Commerce
Industry | Research | Consumers | Trade associations
Professional organizations | Public authorities
The trades | Commerce
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The standards idea
Working with stakeholders and for the benefit of all, DIN develops German Standards and other new products which promote
rationalization quality assurance environmental protection security communication globalization innovation
for business, technology, science, government and society in general.DIN publishes these standards, and encourages their implementation.
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DIN is a service provider
DIN functions as a "round table" – and increasingly as an electronic platform – where stakeholders can develop modern consensus-based standards suited to market needs
DINorganizes the entire
standardization processat national level and
German participation in European and international
standards work
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Democratic legitimation of standardization depends on the involvement of all stakeholders
Standardization in joint responsibility
Standardization
Industry SMEs
Consumers Experts Test institutesBusinesses
The State
Commerce
Research
Trades
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Technical expertise
Provided by experts representing stakeholders Authorized as delegates Members of working groups and committees Balanced representation of stakeholder groups
Assisted by DIN staff and DIN standardscommittees
Participants in standards work
Sta
nd
ard
izat
ion
p
roce
ss
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Principles of standardization
Voluntary implementation
Public access Broad participation Consensus Uniformity Consistency Relevancy Current knowledge Current technology Efficiency Of benefit to all International
Cartel law Consumer
acceptance Legitimation Product liability SME acceptance Global acceptance
Features of consensus-based standardization
Principles ofstandards work
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Check bystandardseditingboard
Check bystandardseditingboard
Public reviewPublic review
Review bystandardseditingboard
Review bystandardseditingboard
MediationArbitrationMediationArbitration
Public reviewPublic review
Proposal
Working document
German Standard –DIN Standard
Manuscript of draft standard
Draft standard
Manuscript of standard
Development of a standard – Overview
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The old days: Trade barriers hindered the European economy
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DIN represents German interests in international standards work
National
Regional
Inter-national
German Institute for Standardization
Sectors
Engineering
Construction
Services
Informationtechnology
Aerospace
Medical technology
Precision engineering
...
Electrotechnology
Tele- communications
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Most DIN Standards originate at European level
Source of new DIN Standards (in %)
0
1 0
2 0
3 0
4 0
5 0
6 0
7 0
8 0
9 0
1 0 0
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86
19
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19
90
19
91
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92
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20
00
20
01
20
02
20
03
20
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20
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20
06
20
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08
D IN E N IS O ( e u r o p e a n ) D IN IS O u n d D IN IE C ( in t e r n a t io n a l)
D IN ( n a t io n a l)
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Involvement in European and International Standards Committees
MirrorCommittee
Technical
Committee
WorkingGroup
Delegates
Experts
DIN ISO CEN
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Vienna and Dresden Agreements
where possible, carry out specialist work at one level of standardization, and use parallel voting procedures to achieve simultaneous adoption as ISO/IEC and EN Standards
Vienna Agreement
Dresden Agreement
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Member countries in European standards bodies
CEN/CENELEC Full Members (30) CEN/CENELEC Affiliates as of July 2009Kartenvorlage: www.data2map.de
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Initiate international standards projects in technology sectors in which Germany is a leader
Timely launch of national standards projects, if technologies from elsewhere threaten to compete, and consensus-building with major business partners prior to international standards work
Increase active involvement in European and International Standards projects, in order to secure position in the global marketplace
Consistent adoption of European and International Standards as national standards
National role in international standardization activities
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Standards and technical rules
Time
Level of consensus
Innovation(new product,new procedure)
Development process Market maturityinvestmentsecurity
100%
Company standard, patent(single business)
Sector standard(closed circle of companies)
Specification(publicy accessible,
available through standards body)
Standard(publicly accessible,
available through standards body)
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DIN SPEC – DIN Specification
DIN-Fachbericht PAS
DIN VornormCWA
DIN SPEC
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DIN Standard
Standardization
production
publication
application
Specification
Revision of standard after 5 years
A DIN SPEC can be the fundament for standardization activities
Revision DIN SPEC after 3 years
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……
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Standardization for Nanotechnologies
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Standardization for Nanotechnologies
Norbert Siegel DIN Deutsches Institut für NormungR&D Phase Standardization Department
NaPolyNet Seminar and Workshop Berlin October 30th, 2009
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Nanotechnologies
• what is standardization?• national and international standards• history and prehistory• current status of formal standards• non formal standards
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Nanotechnologies
Qin Shihuan-diImperator of China
200 B.C.
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Imperator Qin Shihuan-di 200 BC
Standards for
• wheelbases of transport carts• opening width of city gates• road construction• dimensions• weight units• weapons and armours
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Nanotechnologies
… 2203 years later …
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Nanotechnologies
History
Dec. 2003 China established „United Working Group“
for nanomaterials standardization
May 2004 Britain: NT standardization TC founded
Oct. 2004 start of work on a PAS for NT terminology
in Britain
Nov. 2004 Japan: „Study Group“ for NT standardization
Dec. 2004 China: publication of 7 national standards
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Nanotechnologies
• what is standardization?• national and international standards• history and prehistory• current status of formal standards• non formal standards
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INTERNATIONAL FORMAL STANDARDIZATION
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Nanotechnologies
ISO TC 229 Nanotechnologies 1
established June 2005
chair Dr. P. Hatto, UK
secretariat Jose Alcorta, BSI, UK
35 members ( 28 + 7 )
liaison with CEN TC 352
liaison with IEC TC 113
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ISO TC 229 Nanotechnologies 2
Working Groups 1
WG 1 Terminology and nomenclature
WG 2 Measurement and characterization
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ISO TC 229 Nanotechnologies 3
Working Groups 2
WG 3 Health, safety and environmental
aspects of NT
WG 4 Material specifications
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ISO TC 229 Nanotechnologies
Standards published
ISO/TS 27687:2008
Nanotechnologies -- Terminology and definitions for nano-objects -- Nanoparticle, nanofibre and nanoplate
ISO/TR 12885:2008
Nanotechnologies -- Health and safety practices in occupational settings relevant to nanotechnologies
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ISO TC 229 Nanotechnologies
Standards under development by TC 229
ISO/WD TS 10797
Nanotubes -- Use of transmission electron microscopy (TEM) in single walled carbon nanotubes (SWCNTs)
ISO/WD TS 10798
Nanotubes -- Scanning electron microscopy (SEM) and energy dispersive X-ray analysis (EDXA) in the charaterization of single walled carbon nanotubes (SWCNTs)
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ISO TC 229 Nanotechnologies
ISO/DIS 10801
Nanotechnologies -- Generation of metal nanoparticles for inhalation toxicity testing using the evaporation/condensation method
ISO/DIS 10808
Nanotechnologies -- Characterization of nanoparticles in inhalation exposure chambers for inhalation toxicity testing
© 2005 D
IN D
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ISO TC 229 Nanotechnologies
ISO/AWI TS 10812
Nanotechnologies -- Use of Raman spectroscopy in the characterization of single-walled carbon nanotubes (SWCNTs)
ISO/CD TS 10867
Nanotubes -- Use of NIR-Photoluminescence (NIR-PL) Spectroscopy in the characterization of single-walled carbon nanotubes (SWCNTs)
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ISO TC 229 Nanotechnologies
ISO/WD TS 10868
Nanotubes - Use of UV-Vis-NIR absorption spectroscopy in the characterization of single-walled carbon nanotubes (SWCNTs)
ISO/CD TS 10929
Measurement methods for the characterization of multi-walled carbon nanotubes (MWCNTs)
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ISO TC 229 Nanotechnologies
ISO/AWI TR 11808
Nanotechnologies -- Guidance on nanoparticle measurement methods and their limitations
ISO/AWI TR 11811
Nanotechnologies -- Guidance on methods for nanotribology measurements
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ISO TC 229 Nanotechnologies
ISO/AWI TS 11888
Determination of mesoscopic shape factors of multiwalled carbon nanotubes (MWCNTs)
ISO/AWI TS 11931-1
Nanotechnologies -- Nano-calcium carbonate -- Part 1: Characteristics and measurement methods
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ISO TC 229 Nanotechnologies
ISO/NP TS 11931-2
Nanotechnologies -- Nano-calcium carbonate -- Part 2: Specifications in selected application areas
ISO/AWI TS 11937-1
Nanotechnologies -- Nano-titanium dioxide -- Part 1: Characteristics and measurement methods
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ISO/NP TS 11937-2
Nanotechnologies -- Nano-titanium dioxide -- Part 2: Specifications in selected application areas
ISO/AWI 12025
Nanomaterials -- General framework for determining nanoparticle content in nanomaterials by generation of aerosols
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ISO TC 229 Nanotechnologies
ISO/CD TR 12802
Nanotechnologies - Terminology and definitions - Framework
ISO/AWI TS 12805
Nanomaterials - Guidance on specifying nanomaterials
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ISO/AWI TS 12901-1
Nanotechnologies -- Guidance on safe handling and disposal of manufactured nanomaterials
ISO/NP TS 12901-2
Guidelines for occupational risk management applied to engineered nanomaterials based on a "control banding approach"
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ISO/AWI TR 13014
Nanotechnologies - Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment
ISO/AWI TR 13121
Nanotechnologies - Nanomaterial Risk Evaluation Framework
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ISO TC 229 Nanotechnologies
ISO/NP TS 13126
Artificial gratings used in nanotechnology -- Description and measurement of dimensional quality parameters
ISO/NP TS 13278
Carbon nanotubes -- Determination of metal impurities in carbon nanotubes (CNTs) using inductively coupled plasma-mass spectroscopy (ICP-MS)
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ISO/DIS 29701
Nanotechnologies -- Endotoxin test on nanomaterial samples for in vitro systems -- Limulus amebocyte lysate (LAL) test
ISO/AWI TS 80004-2
Nanotechnologies -- Terminology and definitions - -- Part 2: Core terms
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ISO TC 229 Nanotechnologies
ISO/WD TS 80004-4
Nanotechnologies - Terminology and definitions -- Part 4: Carbon nano-objects
ISO/AWI TS 80004-5
Nanotechnologies -- Terminology and definitions -- Part 5: Nanostructured materials
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ISO/AWI TS 80004-6
Nanotechnologies -- Terminology and definitions -- Part 6: Bio/nano interface
ISO/AWI 80004-7
Nanotechnologies -- Terminology and definitions -- Part 7: Nanoscale measurement and instrumentation
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ISO TC 229 Nanotechnologies
ISO/AWI TS 80004-8
Nanotechnologies - Terminology and definitions -- Part 8: Medical, health and personal care applications
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ISO TC 201 Surface chemical analysis
30 standards published on AES, XPS, SIMS
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ISO TC 202 Microbeam analysis
9 standards published on electron probe microanalysis
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ISO - other TCs 1
TC 146 SC 2 Workplace atmospheres:
ISO TR 27628: Workplace Atmospheres – Ultrafine, nanoparticle and nano-structured aerosols – Inhalation exposure characterization and assessment
under devolopment
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ISO - other relevant TCs 2
ISO TC 213 Dimensional and geometrical product specifications and verification
TC 209 Cleanrooms and associated controlled environments
TC 24 SC 4 Sizing by methods other than sieving
TC 48 Laboratory equipment
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ISO - other TCs 3
TC 61 Plastics
for example: TC 61/SC 13 Composites and reinforcement fibres
TC 207 Environmental management
TC 150 Implants for surgery
REMCO ISO Committee on reference materials
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ISO - other TCs 4
TC 194 Biological evaluation of medical devices
TC 194/WG 5 Cytotoxicity
TC 194/WG 6 Mutagenicity, cancerogenicity and reproductive toxicity
TC 194/WG 7 Systemic toxicity
…
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IEC TC 113 Nanotechnology:
Standardization for electrical and electronicsproducts and systems
founded March 2007chair Dr. T. Chapin, USAsecretary Dr. Norbert Fabricius, Germany
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IEC TC 113 Working Groups :
JWG 1 : Terminology and nomenclature (Joint Working Group with ISO TC 229, ISO lead)
JWG 2 : Measurement and characterization (Joint Working Group with ISO TC 229, ISO lead)
WG 3 : Performance of Nanomaterials for Electrotechnical Components and Systems
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IEC TC 113 Nanotechnology
Work items 1:
PNW/TS 113-54 Ed. 1.0
Technical Specification for the Determination of Metal Impurities in Carbon Nanotubes (CNTs) Using Inductively Coupled Plasma-Mass Spectroscopy (ICP-MS)
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Work items 2:
IEC 62565 Ed. 1.0
Guideline for carbon nanotubes specifications for electrotechnical applications
ISO 11751 Ed. 1.0
Terminology and definitions for carbon nano-objects
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Work items 3:
IEC/TS 62607 Ed. 1.0
Technical Specification for the Electrical Characterization of Carbon Nanotubes (CNTs) Using 4-Probe Measurement
IEC 62624 Ed. 1.0
IEEE Standard test methods for measurement of electrical properties of carbon nanotubes
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EUROPEAN STANDARDIZATION
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CEN TC 352 Nanotechnologies 1
established November 2005
chair Dr. T. Phelps, UK
secretary Dr. D. Michael, BSI, UK
cooperation with ISO TC 226
additionally dealing with items of specific interest for Europe
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CEN TC 352 Nanotechnologies 2
work items were added to the CEN/TC 352 work programme, under the terms of the Vienna Agreement (ISO lead), corresponding to the approved work items of ISO/TC 229
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Published:
CEN ISO/TS 27687:2008
Nanotechnologies - Terminology and definitions for nano-objects - Nanoparticle, nanofibre and nanoplat (ISO/TS 27687:2008)
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CENELEC
no European TC for nanotechnologies
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National standards
national TCs for nanotechnologies
BSI, AFNOR, UNI, NEN, CNI, DIN,…
Europe: no national standards planned
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Deutsche Gremien im DIN German TCs
AA 8-17 Nanotechnologien im NMP
K 141 Nanotechnologien in DKE
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• what is standardization?• national and international standards• history and prehistory• current status of formal standards• non formal standards
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ASTM Committee E 56 Nanotechnology
American Society for Testing and Materials
Committee E 56 was formed in 2005
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ASTM Committee E 56 Nanotechnology
Standards under development:
WK8051 New Standard Terminology for NT
WK8705 Measurement of particle size distribution
of nanomaterials in suspension by
Photon Correlation Spectroscopy (PCS)
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WK8997 Standard Practice for Analysis of Hemolytic Properties of Nanoparticles
WK9326 Standard Practice for Evaluation of the Effect of Nanoparticulate Materials on the Formation of Mouse Granulocyte-Macrophage Colonies
WK9327 Standard Practice for Evaluation of Cytotoxicity of Nanoparticulate Materials on Porcine Kidney Cells
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WK9952 Standard Practice for Measuring Length and Thickness of Carbon Nanotubes Using Atomic Force Microscopy Methods
WK9953 Standard Practice for Measuring Diameter and Wall Thickness of Multi-wall Carbon Nanotubes (MWNT) Using Transmission Electron Microscopy Methods
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WK10417 Standard Practice for the Preparation of Nanomaterial Samples for Characterization
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IEEE
Institute of Electrical and Electronics Engineers
(USA)
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IEEE
standards under development:
P1670: Chemical Vapor Deposition (CVD)
Techniques for Nanotechnologies including
Measurements and Analysis to control
CVD Nanoscale Processes
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P1690: Standard Methods for the
Characterization of Carbon Nanotubes
Used as Additives in Bulk Materials
IEEE 1650-2005: IEEE Standard Test Methods for
Measurement of Electrical Properties of
Carbon Nanotubes . (already published)
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IEEE Nanoelectronics Standards Roadmap
presented on IEEE-SA Nanotechnology
on 22 May 2007 in Santa Clara, California
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OECD
OECD Working Party on Manufactured Nanomaterials
established in March 2007
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OECD
Proposed programme of work 2009-2012
Project 1: Development of a Database on HumanHealth and Environmental Safety Research
Project 2: Research Strategies on Manufactured Nanomaterials
Project 3: Safety Testing of a Representative Set of Manufactured Nanomaterials
Project 4: Manufactured Nanomaterials and Test Guidelines
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Project 5: Co-operation on Voluntary Schemes and Regulatory Programmes
Project 6: Co-operation on Risk Assessment
Project 7: The role of Alternative Methods in Nanotoxicology
Project 8: Exposure Measurement and Exposure Mitigation