In 1946, delegates from 25 countries met in London and decided to create a new international organization, of which the object would be "to

Transcription

1 ISO TC 229 Nanotechnologies World L.-S. Nieh, Ph.D. U.S. Forest Service

2 History of the International Organization for Standardization di ti (ISO) In 1946, delegates from 25 countries met in London and decided to create a new international organization, of which the object would be "to facilitate the international coordination and unification of industrial standards". The new organization, ISO, officially began operations on 23 February 1947, in Geneva, Switzerland 6/9/2011 Nanocellulose Standards Workshop 2

3 ISO TC 229 Profile ISO TC229 was created in Current Chair: Dr. Peter Hatto (UK), until Current Secretariat: British Standards Institute (BSI). Participating i countries: 34 Observing countries: 11 6/9/2011 Nanocellulose Standards Workshop 3

4 ISO TC 229 Nanotechnologies Chairman Advisory Group Advisory body to the Technical Committee Chair Task Group 2 Task Group 3 Consumer and societal dimensions of nanotechnologies Nanotechnologies and sustainability Nanocellulose Task Group* Discuss nanocellulose international standards development within the ISO organization *To be proposed by U.S., Canada, Finland, Japan, RSA 6/9/2011 Nanocellulose Standards Workshop 4

5 Function and Tasks of the Proposed Task Group Bring existing and future discussion of nanocellulose international standards development into the ISO TC229 structure. Develop strategies to ensure efficient development of a suite of internationals standards for nanocellulose through proposals of new work items. Identify and reach out to other ISO TC s (TC 6, Paper, Board and Pulps for example) that will have an interest in ISO standards development in nanocellulose or its application. Identify and reach out to experts, industries, delegations and other standards-developing developing organizations such as CEN and OECD to join the nanocellulose standards developing activities. (ISO has agreements to work with CEN, OECD.) 6/9/2011 Nanocellulose Standards Workshop 5

6 Status of the Nanocellulose Task Group Proposal The draft was reviewed by stakeholders in U.S., Canada, Norway, Finland, RSA, Japan, and others. The proposal is currently in the U.S. TAG for discussion to propose to ISO TC 229. The proposal may be co-sponsored by U.S., Canada, Finland, Japan, RSA. 6/9/2011 Nanocellulose Standards Workshop 6

7 Stages and Associated Documents in ISO Standards Development Preliminary Work Item PRELIIMINARY (PWI) New Work Item PROPOSAL (NP) Working Draft PREPARATORY (WD) Committee Draft COMMITTEE (CD) Draft International Standard ENQUIRY (DIS) Final Draft International Standard APPROVAL (FDIS) International Standard PUBLICATION (IS)

8 Who Can Propose New Work Items? Proposals can come from many sources, both within and outside ISO National body member (participating on the respective TC or SC) TC/SC Secretariat Another TC/SC Liaison Organizations TMB or Advisory Group CEO 6/9/2011 Nanocellulose Standards Workshop 8

9 Key Documents in the ISO Process New work item proposal p Can be proposed by a national body, secretariat of TC, other TC, liaison organization, oga ato TMB or the ec CEO The originator shall make every effort to provide a first working draft (or outline of a working draft), nominate a project leader, propose date of publication Approval by simple majority of P- members in TC or SC voting Project leader and experts to develop a working draft PRELIIMINARY (PWI) PROPOSAL (NP) PREPARATORY (WD) COMMITTEE (CD) ENQUIRY (DIS) APPROVAL (FDIS) PUBLICATION (IS) 6/9/2011 Nanocellulose Standards Workshop 9

10 Key Documents in the ISO Process Committee Draft CD s are circulated to P- and O- members for comment, resolve technical ca issues, consensus. sus "consensus::...absence of sustained opposition to substantial issues... and by a process that involves seeking to take into account the views of all parties concerned and to reconcile any conflicting arguments. NOTE: Consensus need not imply unanimity. When in doubt 2/3 of P- members in TC or SC voting PRELIIMINARY (PWI) PROPOSAL (NP) PREPARATORY (WD) COMMITTEE (CD) ENQUIRY (DIS) APPROVAL (FDIS) PUBLICATION (IS) 6/9/2011 Nanocellulose Standards Workshop 10

11 Key Documents in the ISO Process For a CD to be accepted as an ISO International Standard, it must be approved by at least two-thirds thirds of the ISO national members that participated in its development and not be disapproved by more than a quarter of all ISO members who vote on it. PRELIIMINARY (PWI) PROPOSAL (NP) PREPARATORY (WD) COMMITTEE (CD) ENQUIRY (DIS) APPROVAL (FDIS) PUBLICATION (IS) 6/9/2011 Nanocellulose Standards Workshop 11

12 ISO Standards Development Time limit Technical Committee or Subcommittee decide target dates of completion but ISO guidance time limits are: Working draft: 6 month Committee draft: 12 month Enquiry draft: 24 month Approval draft: 33 month Publish standard: 36 month ISO TMB will terminate a project after 5 years 6/9/2011 Nanocellulose Standards Workshop 12

13 ISO Products ISO products, Besides ISO Standards Technical Specifications... subject... still under development or... there is the future but not immediate possibility of an agreement to publish an International Standard Require 2/3 majority of P-members voting in TC or SC Reviewed in 3 years to convert to standards Publicly Available Specifications (PAS) A PAS may be an intermediate specification, published prior to the development of a full International Standard Simple majority of P-members voting in TC or SC Convert to normative document in 3 years Technical Reports Data normally different from standards, simple majority of P- members voting in TC or SC

14 Nanocellulose is New for ISO TC229 Organizing around a single material is new for ISO TC229. Creating a Task Group to organize a single material is new for ISO TC229. There will be opportunities to partner with other ISO TC s, organizations. 6/9/2011 Nanocellulose Standards Workshop 14

15 Please Let Us Know The state of development of nanocellulose and its target application in your country. Commercialization and marketing outlook. Based on the state of development and commercialization outlook,,p please present your opinion on what are the international standards needed in order to facilitate nanocellulose l R&D and commercialization. i 6/9/2011 Nanocellulose Standards Workshop 15

16 Goals and Products of the Workshop kh Roadmap for nanocellulose international standards development. Designate leads to develop new work item proposals to be formally proposed to ISO TC229 at the Johannesburg RSA meeting in Nov Keep workshop participants i t together th as steering group for nanocellulose international ti standards d development. 6/9/2011 Nanocellulose Standards Workshop 16

17 We need volunteers to help us write the report. If you are interested, please join the discussion leads, scribes and organizing chairs at 3:00 pm to discuss report writing and assignments. TAPPI will make the presentations available. Please send your presentation to Colleen Walker. 6/9/2011 Nanocellulose Standards Workshop 17

18 ISO TC229 Published Products WG1 Terminology and Nomenclature Nanotechnologies Model taxonomic framework for use in developing vocabularies Core concepts (ISO/TR 12802:2010) Nanotechnologies -- Terminology and definitions for nano- objects -- Nanoparticle, nanofibre and nanoplate (ISO/TS 27687:2008 ) Nanotechnologies -- Vocabulary -- Part 3: Carbon nano-objects objects ( ISO/TS :2010) Nanotechnologies -- Methodology for the classification and categorization of nanomaterials (ISO/TR 11360:2010) Nanotechnologies Vocabulary Part 1: Core terms (ISO/TS :2010)

19 ISO TC229 Published Products WG2 Characterization and Metrology Nanotechnologies -- Characterization of single-wall carbon nanotubes using near infrared photoluminescence spectroscopy (ISO/TS 10867:2010) Nanotechnologies Characterization of volatile components in single wall carbon nanotube samples using evolved gas analysis/gas chromatograph-mass mass spectrometry t (ISO/TS 11251:2010) 2010) 6/9/2011 Nanocellulose Standards Workshop 19

20 ISO TC229 Published Products WG3 Environment, Health and Safety Nanotechnologies - Health and safety practices in occupational settings relevant to nanotechnologies (ISO/TR 12885:2008) Nanotechnologies - Nanomaterial risk evaluation (ISO/TR 13121:2011) Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test (ISO 29701:2010) Nanotechnologies -- Characterization of nanoparticles in inhalation exposure chambers for inhalation toxicity testing (ISO 10808:2010) Nanotechnologies -- Generation of metal nanoparticles for inhalation toxicity testing using the evaporation /condensation method (ISO 10801:2010) 6/9/2011 Nanocellulose Standards Workshop 20

21 Ongoing Projects - WG 1 Terminology and Nomenclature Terminology and definitions - Part.4: Nanostructured materials Terminology and definitions - Part 5: Bio/nano interface Terminology and definitions - Part. 6: Nanoscale measurement and instrumentation Terminology and definitions - Part 7: Medical, health and personal care applications Terminology and definitions - Part 10: Nanomanufacturing processes Framework for nomenclature models for nano-objects

22 Ongoing Projects - WG 2 Measurement & Characterization ti Characterization of SWCNTs using TEM Characterization of SWCNTs using SEM/EDXA Characterization of SWCNTs using UV-Vis-NIR absorption spectroscopy Measurement methods for the char. MWCNTs Characterization of SWCNTs using TGA Determination of mesoscopic shape factors of MWCNTS General framework for determining i nanoparticle content t in nanomaterials by generation of aerosols Artificial gratings used in nanotechnology -- Description & measurement of dimensional quality parameters Determination of metal impurities in CNTs using ICP-MS Generic requirements for reference materials for development of methods for characteristic testing, performance testing and safety testing of nanoparticle and nano-fiber powders

23 Ongoing Projects - WG 3 EH&S Guidance on phy.-chem. char. MNOs submitted for toxicological testing Guide to safe handling & disposal MNMS Guidelines for occupational risk management applied to ENMs based on a "control banding approach" Preparation of safety data sheets (SDS) for nanomaterials Detection of surface bound molecules to gold nanoparticles using FT-IR spectroscopy Guidance on Toxicological Screening Methods for MNMs Guidance on Sample Prep. Methods & Dosimetry Considerations for MNMS Muramic Acid as a Biomarker for Silver Nanoparticles Activity

24 Ongoing Projects - WG 4 Materials Specifications Nano-calcium carbonate -- Part 1: Characteristics and measurement methods Nano-titanium dioxide Part 1: Characteristics and measurement methods Nanomaterials - Guidance on specifying i nanomaterials Nanotechnology - nano particles in powder form - characteristics and measurements

25 Thank You! World Nieh U.S. Forest Service National Headquarters Program Lead Forest Products and Wood Utilization f 6/9/2011 Nanocellulose Standards Workshop 25

26 ISO Is Democratic - Full member has the right to take part in the development of any standard. Each member has one vote. Voluntary ISO is a non-government organization. ISO standards are voluntary. Market-driven - ISO only develops standards for which there is a market requirement. Consensus-based - ISO standards are based on international consensus among the experts in the field. Globally relevant - are designed to be globally relevant, useful everywhere in the world. 6/9/2011 Nanocellulose Standards Workshop 26

27 Terminology and Definitions for Nano-objects objects (TS) Core Terms Nanoscale: size range from approximately 1 nm to 100 nm. Nano-object: object: material with one, two or three external dimensions in the nanoscale. ISO/TS Nanotechnologies Terminology and definitions for nano- objects Nanoparticle, nanofibre and nanoplate 6/9/2011 Nanocellulose Standards Workshop 27

28 Terminology and Definitions for Nano-objects objects (TS) Nanoparticle: all three external dimensions in the nanoscale Nanoplate: one external dimension in the nanoscale and two others external dimensions significantly larger Nanofiber: two similar external dimensions in the nanoscale and the third dimension significantly larger ISO/TS Nanotechnologies Terminology and definitions for nano- objects Nanoparticle, nanofibre and nanoplate 6/9/2011 Nanocellulose Standards Workshop 28

29 Needs for Standards in Nanotechnology To support commercialization and market development To provide a basis for procurement through technical requirements, and quality and environmental management To support voluntary governance structures and appropriate p legislation and regulation 6/9/2011 Nanocellulose Standards Workshop 29

30 ISO TC 229 Nanotechnologies Working Group 1 Working Group 2 Terminology and Nomenclature Metrology and Characterization Convened by Canada Define and develop unambiguous and uniform terminology and nomenclature in the field of nanotechnologies to facilitate communication and to promote common understanding. Convened by Japan The development of standards for measure- ment, characterization ti and test t methods for nanotechnologies, taking into consideration needs for metrology and reference materials. Working Group 3 Working Group 4 Health, Safety and Environment Material Specifications Convened by U.S.A. The development of science-based standards in the areas of health, safety, and environmental aspects of nanotechnologies. Convened by China Develop standards for specifying nano-materials 6/9/2011 Nanocellulose Standards Workshop 30