din deutsches institut für normung e. v. napolynet © 2009 din e. v. 1 what is standardization?...

DIN Deutsches Institut für Normung e. V.

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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

87

19

88

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89

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90

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91

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92

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00

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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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Nanotechnologies

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



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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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Nanotechnologies


Working Groups 1

WG 1 Terminology and nomenclature

WG 2 Measurement and characterization


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Nanotechnologies


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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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/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

eutsches Institut für Norm

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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/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/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/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/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/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/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/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/AWI TS 80004-8

Nanotechnologies - Terminology and definitions -- Part 8: Medical, health and personal care applications


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Nanotechnologies

ISO TC 201 Surface chemical analysis

30 standards published on AES, XPS, SIMS


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Nanotechnologies

ISO TC 202 Microbeam analysis

9 standards published on electron probe microanalysis


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Nanotechnologies

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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Nanotechnologies

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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Nanotechnologies

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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Nanotechnologies

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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Nanotechnologies

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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Nanotechnologies

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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Nanotechnologies

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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Nanotechnologies

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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Nanotechnologies

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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Nanotechnologies

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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Nanotechnologies

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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Nanotechnologies

National standards

national TCs for nanotechnologies

BSI, AFNOR, UNI, NEN, CNI, DIN,…

Europe: no national standards planned


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Nanotechnologien

Deutsche Gremien im DIN German TCs

AA 8-17 Nanotechnologien im NMP

K 141 Nanotechnologien in DKE


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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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Nanotechnologies

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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Nanotechnologies

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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Nanotechnologies

WK10417 Standard Practice for the Preparation of Nanomaterial Samples for Characterization


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Nanotechnologies

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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Nanotechnologies

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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Nanotechnologies

IEEE Nanoelectronics Standards Roadmap

presented on IEEE-SA Nanotechnology

on 22 May 2007 in Santa Clara, California


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Nanotechnologies

OECD

OECD Working Party on Manufactured Nanomaterials

established in March 2007


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Nanotechnologies

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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Nanotechnologies

OECD

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

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