Report of WG Standardization in Nanofutures November 2014

(Michael.Stintz@tu-dresden.de)

ISO/TC 229 Nanotechnologies

The actually best overview about the concept of ISO-standardization in Nanotechnologie is the public available business plan from 2012:

5 OBJECTIVES OF TC 229 AND STRATEGIES FOR THEIR ACHIEVEMENT http://isotc.iso.org/livelink/livelink?func=ll&objId=8927779&objAction=browse&viewType=1

5.1 Defined objectives of TC 229 In accordance with the ISO strategic plan for 2005 to 2010, in operation at its establishment, ISO TC 229, develops robust standards and other deliverables relevant to nanotechnologies that:

• Support the sustainable and responsible development and global dissemination of these emerging technologies;

• Facilitate global trade in nanotechnologies, nanotechnology products and nanotechnology enabled systems and products;

• Support improvement in quality, safety, security, consumer and environmental protection, together with the rational use of natural resources in the context of nanotechnologies;

• Promote good practice in the production, use and disposal of nanomaterials, nanotechnology products and nanotechnology enabled systems and products.

The work of the Technical Committee focussed initially on the areas of terminology and nomenclature, metrology and test methods, and health, safety and the environment. In 2008 this was extended to include Material Specifications.

ISO TC 229 will review its strategy with the approval of new ISO Strategic Plans in order to support the overall objectives of ISO, in particular to help it achieve its Global Vision ‘to be the world’s leading provider of high quality, globally relevant International Standards through its members and stakeholders’.

5.2 Identified strategies to achieve TC 229’s defined objectives.

A list of the Standards under development may be found at TC229 Work program. The diagram below shows the current TC229 structure, designed to support the efficient and orderly development of Standards.

The following table lists the key TC 229 strategies and the corresponding actions.

No. Strategies Actions 01.

Establish appropriate structures within ISO/TC 229 to support timely and optimal development of International Standards and other deliverables – Technical SpecificationsTechnical Reports, etc

1. Establishment of four working group (WG)s under TC

JWG1 - Terminology and Nomenclature Scope: To define and develop an unambiguous and uniform terminology and nomenclature for nanotechnologies to facilitate communication and promote common understanding JWG2 – Measurement and Characterization Scope: To develop standards for measurement, characterization and test methods for nanotechnologies taking into consideration needs for metrology and reference materials WG3 – Health, Safety and Environment Scope: To develop science-based standards in the areas of health, safety and environmental aspects of nanotechnologies WG4 – Material Specification Scope: To specify relevant characteristics of engineered nanoscale materials for use in generic/specific applications. 2. Establishment of Groups under the TC and WGs

i. Chairman’s Advisory Group (CAG) to provide strategic advice to the TC 229 Chair on matters and issues related to TC 229;

ii. Nanotechnologies Liaison Coordination Group to provide a forum to help coordinate and harmonise the work of relevant TCs and other organisations in the field of nanotechnologies and to identify cross-cutting gaps and opportunities and ways to address these;

iii. Planning and Coordination Task Group to monitor the work programme of TC 229 to ensure that it supports the Roadmaps as approved by the TC; to address issues of internal coordination through recommendations to the appropriate committee structures; and to maintain the TC Business Plan;

Nanotechnologies and Sustainability Task Group to review the opportunities for nanotechnologies to address issues in the sustainability arena and to consider if and how standards might contribute to the successful implementation of these solutions for the benefit of mankind.

ISO/TC 229 STRUCTURETC 229TC 229

JWG 1Terminology & Nomenclature

JWG 2Measurement &Characterization

WG 3Health, safety &

environment

WG 4Material

specifications

NLCGNLCG CAGCAG

Nanotechnology & sustainability TG

Nanotechnology & sustainability TG

Planning & coordination TG

Societal &Consumer issues

TG

Societal &Consumer issues

TG

Consumer and Societal Dimensions Task Group to identify important issues in these fields and makes recommendations to TC 229 on topics including: (a) Priorities for standards development in the area of consumer and societal dimensions of nanotechnologies; (b) Promotion of TC 229 standards and informational outputs to end users and other relevant organizations in collaboration with appropriate partners, e.g., ISO COPOLCO, IEC, OECD, UNESCO; (c) Development of mechanisms for TC 229 to encourage and receive input from relevant consumer and other societal organizations; (d) Identification of topics in the area of consumer and societal dimensions of nanotechnologies for which it would be important for TC 229 to establish liaisons with other relevant standardization committees.

02. Evaluating existing standards relevant to the field of nanotechnologies

Conduct comprehensive survey amongst relevant TCs and international and national standardization bodies: A survey was conducted in 2006 of the needs of members with a view to preparing a draft road map identifying and harmonizing priorities, and timescales for deliverables. The survey consisted of a structured questionnaire, with information sought on needs for:

• Generic standards; • standards specific to particular materials or material types; • standards for test methods; • standards relevant to occupational and environmental health; • standards relevant to risk assessment and life cycle analysis; • other standards relevant to nanotechnologies.

This survey was repeated in 2011 and will be repeated periodically to ensure that changing needs are identified and addressed

03. Construct and maintain roadmaps of standardization needs for each working group

Each WG to develop roadmaps with specific project timelines through to 2020

04. Collaborate with all relevant technical com-mittees of ISO and IEC and other bodies to identify the best solu-tion for standards deve-lopment needs in the nanotechnologies

1. Formation of Joint Working Groups for projects of mutual interest 2. Establish formal liaisons and appoint Liaison Officers for each TC and other body

05. Identify and prioritize areas needing research to support the deve-lopment of standards

Conduct surveys. Liaise with organisations such as VAMAS (Versailles project on Advanced Materials and Standards), OECD, BIPM (International Bureau of Weights and Measures), national research bodies, etc.

06. Work with national standards bodies to facilitate feedback and adoption of new nanotechnology standards by ISO members

1. Encourage national standards bodies to submit new work item proposals (NWIP) based on documents developed at the national level 2. Encourage national standards bodies to form mirror WGs to enable local experts to participate in providing input and contributions to projects under the respective WGs and facilitate feedback for ballots 3. Encourage national standards bodies to organize seminars to create awareness on the importance of developing nanotechnologies standards to assist the innovation process, to address the challenges in measurement at the nanoscale, and how they can help to address concerns over potential health and environmental impacts through the use of validated and standardised test methods and protocols to determine the hazards and risks posed by nanomaterials and nanotechnologies based products. 4. Encourage member bodies to uphold the principle of consensus by responding to ballots from a position of knowledge and to ensure that their responses reflect the views of their national experts. 5. Encourage and support members to ensure that their experts receive appropriate training in the principles and processes that govern the development of international standards.

07. Promote awareness activities of TC 229 to industry, scientific communities and general public

1. Encourage member bodies to organize awareness seminars

ISO TC 229, JWG1 Terminology & Nomenclature Convener Report, Nov 2014, New Delhi, India: JWG1: ISO/IEC-TS 80004 Nanotechnologies — Vocabulary series (terms and definitions) Part 1: Core terms – TS 80004-1 pub. 2010; rev. will pub. soon 2015 (Canada-lead)

Part 2: Nano-objects – TS 80004-2 will publish soon in 2015; then withdraw TS 27687

(UK-lead)

Part 3: Carbon nano-objects – TS 80004-3 published 2010

Part 4: Nanostructured materials – TS 80004-4 published 2011

Part 5: Nano/bio interface – TS 80004-5 published 2011

Part 6: Nano-object characterisation –TS 80004-6 published 2013 (UK-lead)

Part 7: Diagnostics and therapeutics for healthcare – TS 80004-7 pub.2011 (US-lead)

Part 8: Nanomanufacturing processes – TS 80004-8 published 2013 (USA-lead)

Part 9: Electrotechnical products and systems – CD ballot resolution (Italy-lead)

Part 10: Photonics components and systems – CD ballot resolution (Norway-lead)

Part 11: Nanolayer, nanocoating, nanofilm – underway (UK / Germany-lead)

Part 12: Quantum phenomena in nanotechnology – underway (Russian Fed. /

France)

Part 13: Graphene and other 2-D materials – underway (UK-lead)

PWI- Part 14: Cellulose nanomaterials – NWIP anticipated from the USA

Pre-work item JWG1

JWG1: Technical Reports: Terminology and Nomenclature

•Nanotechnologies – Model taxonomic framework for use in developing vocabularies – Core concepts – TR 12802 published 2010 (Canada lead)

•Nanotechnologies – Methodology for the classification and categorization of nanomaterials – TR 11360 published 2010 (Iran-lead)

•Nanotechnologies – Framework for chemical nomenclature for selected nano-objects – TR 14786 published 2014 (Canada/ USA lead) •Nanotechnologies – Framework for identifying vocabulary development for nanotechnology applications in human healthcare – will publish in 2015 (USA-lead) •Nanotechnologies – Vocabularies for science, technology and innovation indicators – CD ballot resolution (Iran-lead) •Nanotechnologies – Plain language guide to terminology – underway (UK-lead)

Published Publishing soon Underway (draft development)

ISO/TC 229/JWG 02 "Measurement and characterization" Most important actual projects under preparation: 1) PG14 ISO DTS 17466: Use of UV-Vis Absorption Spectroscopy in the Characterization of Cadmium Chalcogenide Quantum Dots (Dr. Guanglu Ge SAC) 2) PG 15: PG15/ ISO DTR 18196: Measurement technique matrix for characterization of nano-objects. 3) PG16 : ISO/NP TS Nanoparticles: Detection and characterization using single-particle ICP-MS N1164, JWG2_N303, JWG2_N317 4) PG17 ISO/NP TR 19716: Characterization of cellulose nanocrystals -- Particle morphology, purity and surface properties Dr. Linda Johnston (SCC) 5) PG18 ISO/NP TR 19733: Matrix of characterization and measurement methods for graphene PG leader Dr. Clare Byeon (KATS) and Drs. A Hight Walker (ANSI) 6) PWI1 ISO/PWI 19805: Support for selecting and setting up online/off-line techniques to fit with size distribution characterization criteria of airborne nanoparticle population PWI1 leader Dr. Sophie Vaslin-Reimann, Dr. Charles Motzkus (AFNOR) 7) PWI2 ISO/PWI 19749: Determination of size and size distribution of nano-objects by scanning electron microscopy PWI2 leader Dr. Andras Vladar (ANSI) How to launch a succusfull New Work Item Proposal?

Cutting-edge measurement techniques are usually used in the Nanotechnology. Some of them might be immature for the standardization. In order to get support from JWG2 experts easier, to present the evidence showing validity of proposed method is highly recommended. One of the most suitable method to confirm and/or to brush up the proposal at pre-normative stage is VAMAS interlaboratory study. See the Metrology check list at the next page:

ISO/TC 229 – IEC/TC113 / JWG2_N095 This document has been developed in the Study Group on Metrology of ISO/TC229/JWG2. Readers are encouraged to send comments and suggestions on this document to gert.roebben@ec.europa.eu.

eparation and evaluation of NWIPs and WDs in JWG2 For a definition of the terms used above, the reader is encouraged to consult the Metrological Guidelines document produced also in the JWG2 Study Group on Metrology [ISO/TC 229 – IEC/TC113 / JWG2_NXXX], or the ISO/IEC Guide 99 ["International vocabulary of metrology – basic and general concepts and associated terms (VIM)", ISO, Geneva (2007)].

The relevant standardization activities in other technical committees (TC) are regularly reported by the liaison officers and also public available under

http://isotc.iso.org/livelink/livelink?func=ll&objId=10853020&objAction=browse&viewType=1

An example is the last report from ISO/TC 24/SC 4 “Particle Characterization” to the last TC 229 Meeting 3.-7.11.2014 in Delhi. This TC and TC 201 “Surface Chemical Analysis“ are the most relevant „vertical“, that is method relevant, committees, even if they address not explicitly “Nano” in the headline of their methods:

Internal Liaison Report to ISO/TC 229 'Nanotechnologies'

From TC (number): ISO/TC 24/SC 4 Date 10 October 2014 From TC (full name): Particle Characterization Liaison Officer: Prof. Michael Stintz (e-mail michael.stintz@tu-dresden.de) PART 1: Essential information New standards relevant to ISO/TC 229 (New = since previous NLCG meeting) Number Title Published Next

review due ISO 13099-3

Colloidal systems -- Methods for zeta potential determination -- Part 3: Acoustic methods

2014 2019

ISO 13322-1

Particle size analysis -- Image analysis methods -- Part 1: Static image analysis methods

2014 2019

ISO 9276-2

Representation of results of particle size analysis -- Part 2: Calculation of average particle sizes/diameters and moments from particle size distributions

2014 2019

Important standards under development relevant to ISO/TC 229 (NEW in italic) Project Number

Title Current stage

Expected publication

date 9276-1 Representation of results of particle size analysis – Part

1: Graphical representation Revision WD

2016

14411-1

Preparation of particulate reference materials -- Part 1: Quasi-polydisperse material based on picket fence of quasi-monodisperse spherical particles

CD 2015

17867 Particle size analysis -- Small angle X-ray scattering method

FDIS 2015

21501-4 Determination of particle size distribution – Single particle light interaction methods – Part 4: Light-scattering airborne particle counter for clean spaces

NP 2016

27891 Aerosol particle number concentration – Calibration of condensation particle counters

ISO 2014

19430 Determination of particle size distribution -- Particle tracking analysis

DIS 2015

15901-1 Pore size distribution and porosity of solid materials by mercury porosimetry and gas adsorption — Part 1: Mercury porosimetry”,

FDIS 2014

22412 Particle size analysis — Dynamic light scattering CD 2016 20998-3 Measurement and characterization of particles by CD 2016

acoustic methods — Part 3: Guidelines for non-linear theory

New Work Item Proposals relevant to ISO/TC 229

Title Ballot closes

PWI 12918 Measurement of water sorption and other vapours on solids. PWI 18748 Control of dispersibility PWI 15901-2 Pore size distribution and porosity of solid materials by mercury porosimetry and gas adsorption — Part 2: Analysis of mesopores and macropores by gas adsorption

PWI 15901-3 Pore size distribution and porosity of solid materials by mercury porosimetry and gas adsorption — Part 3: Analysis of micropores by gas adsorption

PWI …Determination of particle size distribution — SAXS method PWI …Surface area from SAXS Coordination issues (0, 1, 2 or max. 3) proposed for discussion at the next NLCG (Nanotechnologies Liaisons Coordination Group meeting). Number Brief description of the issue / question (please < 100 words/item) 1

ISO/PDTR 18196 Nanotechnologies–Measurement Technique Matrix for the Characterization of Nano-objects – Subject to heavy liaison overlap with ISO/TC 24/SC 4 – not only contributions from, but also responsibility of both TCs

2

Invitation of ISO/TC 24/SC 4 to JWG2 of ISO/TC 229 for Joint meeting at 10th of June, 2015 at AFNOR in Paris – But “first option of JWG2 2015 spring meeting is joint with IEC/TC113” (according to JWG2 Convener)

PART 2: Additional information Existing standards relevant to ISO/TC 229 Number Title Published Next

review due ISO 9276-1

Representation of results of particle size analysis – Part 1: Graphical representation, ISO 9276-1:1998/Cor 1:2004

1998

ISO 9276-2

Representation … -- Part 2: Calculation of average particle sizes/diameters and moments from particle size distributions

2001

ISO 9276-3

Representation … -- Part 3: Adjustment of an experimental curve to a reference model

2008

ISO 9276-4

Representation … -- Part 4: Characterization of a classification process

2001

ISO 9276-5

Representation … -- Part 5: Methods of calculation relating to particle size analyses using logarithmic normal probability distribution

2005

ISO 9276-6

Representation … -- Part 6: Descriptive and quantitative representation of particle shape and morphology

2008

ISO 9277 Determination of the specific surface area of solids by gas adsorption -- BET method

2010

ISO/TR 13097

Guidelines for the characterization of dispersion stability 2013

ISO 13318-1

Determination of particle size distribution by centrifugal liquid sedimentation methods -- Part 1: General principles and guidelines

2001

ISO 13318-2

Determination … -- Part 2: Photocentrifuge method 2007

ISO 13318-3

Determination … -- Part 3: Centrifugal X-ray method 2004

ISO 13320 Particle size analysis -- Laser diffraction methods 2009 ISO 13321 Particle size analysis -- Photon correlation spectroscopy 1996 ISO 13322-1

Particle size analysis -- Image analysis methods -- Part 1: Static image analysis methods

2004

ISO 13322-2

Particle size analysis -- Image analysis methods -- Part 2: Dynamic image analysis methods

2006

ISO/TS 13762

Particle size analysis -- Small angle X-ray scattering method

2001

ISO 14887 Sample preparation -- Dispersing procedures for powders in liquids 2000 ISO 14888 Particulate materials -- Sampling and sample splitting for the

determination of particulate properties 2007

ISO 15900

Determination of particle size distribution -- Differential electrical mobility analysis for aerosol particles

2009

ISO 15901-1

Pore size distribution and porosity of solid materials by mercury porosimetry and gas adsorption -- Part 1: Mercury porosimetry

2005

ISO 15901-2

Pore … -- Part 2: Analysis of mesopores and macropores by gas adsorption

2006

ISO 15901-3

Pore … -- Part 3: Analysis of micropores by gas adsorption 2007

ISO 20998-1

Measurement and characterization of particles by acoustic methods –Part 1: Concepts and procedures in ultrasonic attenuation spectroscopy

2006

ISO 21501-1

Determination of particle size distribution -- Single particle light interaction methods -- Part 1: Light scattering aerosol spectrometer

2009

ISO 21501-2

Determination of particle size distribution – Single particle light interaction methods – Part 2: Light scattering liquid-borne particle counter

2007

ISO 21501-3

Determination … -- Part 3: Light extinction liquid-borne particle counter

2007

ISO 22412 Particle size analysis – Dynamic light scattering (DLS) 2008 Additional activities, publications, events, comments, issues relevant for (some of) the NLCG members (free text). Next Meeting is planned for 11/12 June 2015 in Paris at AFNOR List of Working groups

WG 1 "Representation of analysis data " WG 2 "Sedimentation, Classification" WG 3 "Pore Size distribution, porosity" WG 5 "Electrical sensing zone methods" WG 6 "Laser diffraction methods " WG 7 "Dynamic light scattering" WG 8 "Image Analysis methods„ WG 9 "Single Particle light interaction methods" WG 10 "Small angle X-ray scattering method" WG 11 "Sample preparation and reference materials " WG 12 " Electrical mobility and number concentration analysis for aerosol particles " WG 14 "Acoustic methods" WG 15 "Focussed scanning beam techniques" WG 16 “Characterisation of particle dispersion in liquids” WG 17 "Methods for zeta potential determination"

CEN/TC 352 Nanotechnologies update to ISO TC 229 JWG2 SG

(November 4, 2014, New Dehli, Jean-Marc Aublant - TC 352 chairperson)

6 Standards published

EN IS O 10801:2010 (00352003) IS O le a d

Nanotechnologies - Generation of metal nanoparticles for inhalation toxicity testing using the evaporation/condensation method

EN IS O 10808:2010 (00352004) IS O le a d

Nanotechnologies - Characterization of nanoparticles in inhalation exposure chambers for inhalation toxicity testing

CEN IS O/TR 11811:2012 (00352006) CEN le a d

Nanotechnologies - Guidance on methods for nano and microtribology measurements

CEN IS O/TS 13830 : 2013 (00352007) IS O le a d

Nanotechnologies - Guidance on voluntary labelling for consumer products containing manufactured nano-objects

CEN IS O/TS 27687:2009 (00352008) IS O le a d

Nanotechnologies – Terminology and definitions for nano-objects - Nanoparticle, nanofibre and nanoplate

EN IS O 29701:2010 (00352002) IS O le a d

Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test

14 drafts (5 mandated, 2 PWI, 7 ISO/TS to be transposed as CEN ISO TS)

CEN/TS PWI 00352012 S A 2012/06.3

Nanotechnologies – Guidance on detection and identification of nano-objects in complex matrices

CEN/TS PWI 00352013 S A 2012/06.4

Nanotechnologies – Guidelines for determining protocols for the explosivity and flammability of powders containing nano-objects (for transport, handling and storage)

CEN/TS PWI 00352014 SA 2012/06.5

Nanotechnologies – Guidelines for the management and disposal of waste from the manufacturing and processing of manufactured nano-objects

CEN/TS PWI 00352010 S A 2012/06.1

Nanotechnologies - Guidance on measurands for characterising nano-objects and materials that contain them

CEN/TS PWI 00352011 S A 2012/06.2

Nanotechnologies – Guidelines for aspects of Life Cycle Assessment specific to nanomaterial

CEN/TS PWI 00352015

Nanotechnologies - Determination of hydrochemical reactivity of nano-objects for toxiticity studies

CEN/TS PWI 00352009

Nano-responsible development - Integration of risk and benefit assessment in the production, marketing and use of nanotechnologies, nanomaterials and/or products incorporating nanomaterials

DECISION 19/2014 taken by CEN/TC 352 on 2014-10-16

Subject: CEN/TC 352 – Document from ISO/TC 229 (ISO/TC 229 N 1198)

CEN/TC 352 decided to develop the 5 mandated WIs under M 461 (Guidance on measurands for characterizing nano-objects and materials that contain them; Guidelines for aspects of Life Cycle Assessment specific to nanomaterials; Guidance on detection and identification of nano-objects in complex matrices; Guidelines for determining protocols for the explosivity and flammability of powders containing nano-objects (for transport, handling and storage); Guidelines for the management and disposal of waste from the manufacturing and processing of manufactured nano-objects) without the parallel approval of the Vienna Agreement, but invited ISO/TC 229 members to the CEN mandated work if interested in as observers.

Once published, these 5 CEN/TSs could be forwarded or proposed to ISO/TC 229 if requested.

CEN/TC 352 and CEN/CENELEC/ETSI M461

●Based on a "living document“ : The M461 Roadmap

●Master list of 37 potential topics covering the Mandate areas

●14 Technical Committees are involved in the Mandate (7 CEN/TCs, 6 ISO/TCs, 1 IEC/TC):

- CEN/TC 352 has been listed for 10 topics (5 TS under SA2012/06)

- ISO/TC 229 has been listed for 10 other topics (No official position of ISO/TC 229)

- CEN/TC 137 "Assessment of workplace exposure to chemical and biological agents“ has been listed for 5 other topics (9 EN under SA 2012/06)

- CEN/TC 195 "Air filters for general air cleaning" has been listed for 1 other topic (1 EN and 1 TS under SA 2012/06

European conference on standardization for nanotechnologies and nanomaterials: opportunities and challenges

Brussels, December 16, 2014 Open meeting on Standardization for Nanotechnologies and nanomaterials

To a ll participants of CEN/TCs, ISO/TCs and IEC/TC involved in the mandate M/461 + European Technology Platforms, FP7 projects, EU initiatives, European Commission and EU agencies, OECD, etc.

To promote the ongoing a ctivitie s unde r this Ma nda te :

- increase awareness on the topic of nanotechnologies;

- disseminate the results of CEN/TC 352 "Nanotechnologies", CEN/TC 137 "Assessment of workplace exposure to chemical and biological agents", CEN/TC 195 "Air filters for general air cleaning activities", their practices and theirs studies;

- increase and facilitate the exchange of information between the relevant TCs;

- get feedback from external stakeholders (on standardization activities; Research and Technology Development activities; regulation; …)

P ro g ra m a n d we b site : http://international-events.afnor.org/20141216_openmeeting/