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DEVELOPMENT OF INTERNATIONAL STANDARDS FOR NANOTECHNOLOGIES Secondary Information Committee 1 4 July 2012 Jeremy Allan JWG1

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Page 1: DEVELOPMENT OF Secondary Information INTERNATIONAL ... · STANDARDS FOR NANOTECHNOLOGIES Secondary Information Committee 1 4 July 2012 Jeremy Allan JWG1 . ... Gold Nanoparticles (spherical)

DEVELOPMENT OF INTERNATIONAL STANDARDS FOR NANOTECHNOLOGIES

Secondary Information Committee 1

4 July 2012

Jeremy Allan JWG1

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DateXXXX 2 Copyright © 2010 Standards Australia Limited

Overview of JWG1

JWG1 Terminology and Nomenclature Published 6 Technical Specifications: ISO/TS 27687: 2008 Nano-objects - nanoparticle, nanofibre, nanoplate ISO/TS 80004-1: 2010 Core Terms ISO/TS 80004-3: 2010 Carbon nano-objects ISO/TS 80004-4: 2011 Nanostructured materials ISO/TS 80004-5: 2011 Nano/bio interface ISO/TS 80004-7: 2011 Diagnostics and Therapeutics for healthcare

Published 2 Technical Reports

ISO/TR 11360:2010 Methodology for classification and categorization of nanomaterials

ISO/TR 12802:2010 Model Taxonomic Framework for use in developing vocabularies – Core concepts

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DateXXXX 3 Copyright © 2010 Standards Australia Limited

Overview of JWG1

JWG1 Terminology and Nomenclature

Two Technical Specifications progressing to final editing stage: ISO/TS 80004-6: 2012 Nano-object characterization

ISO/TS 80004-8: 2012 Nanomanufacturing processes

One Report in final editing stage: Nano-object Nomenclature Establishing a Framework for Developing Chemical Nomenclature for Selected Nano-Objects

Task Groups: Nano-object Nomenclature Nanocrystalline Cellulose

Nanomedicine

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DateXXXX 4 Copyright © 2010 Standards Australia Limited

Overview of JWG1

JWG1 Terminology and Nomenclature

New Programs of work:

Nanotechnology and Nanoscience Indicators (Iran)

Films, Coatings and Membranes (Germany)

Quantum Phenomena in Nanotechnology (Russia)

Plain Language Guide to Nanotechnology Vocabulary (Great Britain)

Pre-work items:

Electrochemical products and systems

Photonic components and systems

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Nanomaterials Classification – Morphological Relationships

Gold Nanoparticles

(spherical)

Gold Nanoparticles (branched)

Nanostructured aggregate (multiple primary subunits of nanosilica)

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DateXXXX 6 Copyright © 2010 Standards Australia Limited

nanomaterial

nanotechnology products General terms for particles

nanostructured agglomerate

nanostructured aggregate

fluid nanodispersion

nano-suspension

nano-emulsion

nano-aerosol

collections

nanostructured powder

nanopowder

nano-objects

nanoparticle

nanofibre

nanotube

nanorod

nanowire

nanoplate

quantum dot

nanostructured material

films, coatings, membranes

solid nanofoam

nanocomposite

nanoporous material

nanocoating

particle

aggregate

agglomerate

primary particle

secondary particle

nanoscale nanofunction

material specifications performance standards

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DateXXXX 7 Copyright © 2010 Standards Australia Limited

Priorities Review of ISO/TS 27687 (becomes 80004-2)

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

Unique terms defined: agglomerate nanotube aggregate nanowire equivalent diameter particle nanofibre quantum dot nanoparticle specific surface area nanoplate mean diameter nanorod ultrafine particle

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DateXXXX 8 Copyright © 2010 Standards Australia Limited

Priorities Review of ISO/TS 27687 (becomes 80004-2)

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

“nanoscale”

“approximately”

“nano-object”

“nanomaterial”

“nano-enabled product”

“nano-enhanced product”

“nanopowder”

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“The Nanoscale”   1 to 100nm?   Submicron?   Supranano?   “Novel” effects?   Inhalable particles?

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4 Nanocomposite adhesive 5 x stronger cf pure adhesive Multichannel nanofibres

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DateXXXX 10 Copyright © 2010 Standards Australia Limited

Nanoscale “nanoscale: size range approximately 1 to 100nm” •  many phenomena are unique to materials within this range •  most quantum effects

  De Broglie waves   Coulomb blockade   Tunnel effect

•  some size-dependent physicochemical properties   optical (colour, transparency), hardness, reactivity, magnetism   “non-linear”, “step-change”, “non-Newtonian”

Some sectors consider “nano” to be well beyond 100nm •  some size-dependent physicochemical properties •  nanobiotechnology (viruses up to 300nm; dendrimers) •  toxicological relevance of particulates up to 15,000nm •  “intrinsic” versus “extrinsic” properties •  definition revised to address these concerns

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DateXXXX 11 Copyright © 2010 Standards Australia Limited

Nanoscale “nanoscale: size range approximately 1 to 100nm”

NOTE 1: Properties that are not extrapolations from a larger size will typically, but not exclusively; be exhibited in this size range. For such properties the size limits are considered approximate.

NOTE 2: The lower limit in this definition (approximately 1 nm) is introduced to avoid single and small groups of atoms from being designated as nano-objects or elements of nanostructures, which might be implied by the absence of a lower limit.

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DateXXXX 12 Copyright © 2010 Standards Australia Limited

Nanoscale “nanoscale: size range approximately 1 to 100nm”

NOTE 1: Physical properties and phenomena that are not extrapolations from a larger size will typically, but not exclusively, be exhibited in this size range.

NOTE 2: Fullerenes and graphene are exceptions by derogation

NOTE 3: Biological and EHS issues may require a different size range above the nanoscale

Additional, new term proposed: Bulk Material material of sufficiently large dimensions to have properties independent of size

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Copyright © 2010 Standards Australia Limited

Nano-object “nano-object: material with one, two or three external dimensions in the nanoscale”

nanoparticle nanofibre nanoplate

Nano-object

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Copyright © 2010 Standards Australia Limited

Nano-object “nano-object: discrete material with one, two or three external dimensions in the nanoscale”

nanoparticle nanofibre nanoplate

Nano-object

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DateXXXX 15 Copyright © 2010 Standards Australia Limited

Nano-object “nano-object: discrete material with one, two or three external dimensions in the nanoscale”

Challenges:

•  assigning quantitative thresholds for distinguishing among nano-objects which extend well beyond the nanoscale

•  determining the point at which nanoparticle should be termed a nanofibre or nanoplate

•  describing the “essential structure” e.g. coiled or nested structures which resemble nanoparticle or nanofibre

•  definitions for collections (e.g. nanopowder, NOAA)

•  use of numerical thresholds requires close attention; some means of justification

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DateXXXX 16 Copyright © 2010 Standards Australia Limited

Nano-object “nano-object: discrete material with one, two or three external dimensions in the nanoscale”

Results from recent NSW Nanotechnology Survey illustrate the great diversity of nano-objects and nano-object complexes which are currently being used in research and manufacturing

nanospheres, nanocomposites with polymer matrix, nanopowders, nanotubes, nanofilms, nanosuspensions, nanocomposites with ceramic matrix, fluid nanodispersions, nano-emulsions, nanorods, nanoporous

materials, quantum dots, nanomembranes, nanowires, graphene, nanocomposites with metal matrix, nanosheets, nanostructured capsules,

nanobioconjugates, carbon black, fullerenes, nanoribbons, graphite, nanocarriers, nanocapsules, nano-onions, nanoplatelets, nanodiamonds, nanodots, nanocubes, nano-aerosols, viruses, nanoneedles, nano-arrays,

nanopore sensors, stealth nano-objects, zeolites, nanoclusters, polyoxometallates

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DateXXXX 17 Copyright © 2010 Standards Australia Limited

Core Terms ISO/TS 80004-1:2010 – Executive Summary Nanotechnologies – Vocabulary – Part 1: Core Terms

Unique terms defined: engineered nanomaterial nanoscale phenomenon incidental nanomaterial nanoscale property manufactured nanomaterial nanoscience nanomanufacturing nanostructure nanomanufacturing process nanostructured material nanomaterial nanotechnology nano-object nanoscale

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DateXXXX 18 Copyright © 2010 Standards Australia Limited

“Nanomaterial” Examination of many proposed and working regulatory definitions

EU Cosmetic Products Regulation EU Recast of the Novel Foods Regulation EU Recommended Definition

French Decree

Health Canada

NICNAS

USA FDA

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DateXXXX 19 Copyright © 2010 Standards Australia Limited

“Nanomaterial”

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DateXXXX 20 Copyright © 2010 Standards Australia Limited

“Nanomaterial” Examination of many proposed and working regulatory definitions

EU Cosmetic Products Regulation EU Recast of the Novel Foods Regulation EU Recommended Definition – “VSSA”, “natural”

French Decree – “nanoparticle state”

Health Canada – “properties distinguishable from bulk”

NICNAS – “industrial nanomaterial”

USA FDA – likely size range up to 1000nm

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DateXXXX 21 Copyright © 2010 Standards Australia Limited

“Nanomaterial” Examination of many proposed and working regulatory definitions

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DateXXXX 22 Copyright © 2010 Standards Australia Limited

“Nanomaterial” ISO/TS 80004-1:2010

material with any external dimension in the nanoscale or having internal structure or surface structure in the nanoscale

Importance of performance standards

Nano-enabled product

Nano-enhanced product

Are current performance standards, specification standards and testing methods sufficient?

Compliance standards

Conformance standards

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DateXXXX 25 Copyright © 2010 Standards Australia Limited

Nomenclature for Nano-objects

Current Status, Aims and Objectives

1.  Official liaison established between ISO and IUPAC

2.  Prioritisation of Nano-object classes

3.  Aim is to facilitate communication between researchers, industry, regulators

4.  Internationally harmonised

5.  Chemical nomenclature, but relies on classification system for physical structure

6.  A nomenclature system for nano-objects be able to differentiate among morphologies

7.  PG11 Technical Report “Framework for chemical nomenclature for selected nano-objects”

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DateXXXX 26 Copyright © 2010 Standards Australia Limited

Nomenclature for Nano-objects

90-nm wide ZnO nanocubes aminoalkane cap"2-90H(6)-(Zn,O)-[(Amn,Alk)]-O"

50-nm diameter ZnO elongated nanorod trefoil barbing, no cap"

2-50RA(3)L-(Zn,O)-0-W"

Zinc Oxide"

Zinc Oxide"

Nano-objects with same core chemistry may have an infinite range of physical morphologies, with vastly different properties.

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DateXXXX 27 Copyright © 2010 Standards Australia Limited

Nomenclature for Nano-objects

Engagement of nomenclature experts required for high priority nano-object classes

Challenges: •  Use of trade names •  Entrenched naming conventions •  Obtaining consensus among experts •  Timeframes for development

PARTITIONED STACKED NANOCONES

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DateXXXX 28 Copyright © 2010 Standards Australia Limited

Innovation Indicators

Nanotechnology Indicators

Numerous metrics and forecasting models established surrounding commerce and industry sectors   “GDP”   medical informatics   computer science   environmental accounting   sustainable development

Measure sectoral performance   international benchmarking   strategic choices

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DateXXXX 29 Copyright © 2010 Standards Australia Limited

Innovation Indicators

(Lux Research, 2005)

Terminology Framework is required for Indicators related to Nanotechnology

•  Over 5 years, the number of consumer nanoproducts increased 521% to over 1,317 products (WWICS, March 2011)

  “Global sales revenues for nanoproducts”

  “Global value of goods incorporating nanotechnology”

  Requires standardised terminology

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DateXXXX 30 Copyright © 2010 Standards Australia Limited

Innovation Indicators

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  Carbon Nano-objects •  CNTs – 300 to more than 1000 t/yr (Van Noorden, 2011; Plata, 2009; Sonderer, 2009)

•  Expected to double each year; already > 1000 t/yr for SWCNT (Klaine, 2008) •  Fullerenes – about 10 t/yr (Sonderer, 2009)

•  90% used in consumer electronics (Sonderer, 2009)

  nAg •  300 to over 500 t/yr (O'Brien, 2010; Sonderer, 2009)

•  Up to 15% of total silver content in European water (Blaser, 2008)

•  Over 950 t/yr (+ 10,000 t/yr CO2) in USA from socks alone (Meyer 2010)

•  nTiO2 •  10,000 t/yr (2011 – 2014) increasing to 2,500,000 t/yr by 2025 •  56 t/yr entering tropical reefs alone from sunscreens (Botta, 2011)

•  nZnO •  20 – 10,000 t/yr (Sonderer, 2009)

•  328% increase in US agricultural soil (from sludge) 30

Building basic data sets demands enormous effort. Modelling studies have huge uncertainty.

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DateXXXX 31 Copyright © 2010 Standards Australia Limited

Innovation Indicators

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  Currently no nano-specific classification of occupations, industry sectors, or administrative processes associated with nanomaterials or nanoproducts

  Classification of research and commercial entities will need considerable examination

–  research organisations with a commercial focus –  commercial entities with an R & D division –  occupations involving the direct handling of nanomaterials –  occupations classified as management units –  ABS reviewing ANZSIC and Occupational Codes in 2015

•  How to define a “skilled” nanotechnology workforce?

•  Nanometrological and nanotoxicological infrastructure capabilities and requirements for industry and research sector

31

Main challenges associated with developing terms and definitions for nanotechnology indicators

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DateXXXX 32 Copyright © 2010 Standards Australia Limited

Nanomedicine Development of Terminology Framework for nanotechnology applications in human healthcare

Four domains established:

1) Prediction / prevention

2) Diagnosis

3) Treatment - pharmaceutical, surgical, implants - stem cell; regenerative

4) Monitoring

Integrates with work on Nano/bio Interface (TS80004-5)

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DateXXXX 33 Copyright © 2010 Standards Australia Limited

Nanocellulose Development of Terminology Framework for Crystalline Nanocellulose

Convened by Canada

•  Canada, Finland and USA most active

•  Transformative development for multiple industries, particularly forestry/agriculture, pulp and paper sectors

•  Opportunities for Australia to contribute to the standardisation process for this sector

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DateXXXX 34 Copyright © 2010 Standards Australia Limited

Nanomanufacturing Processes

Nanomanufacturing Processes

Convened by USA

•  Over 100 terms and definitions

•  Scope currently excludes biological nanomanufacturing processes (or bioprocesses).

•  "processing of biomaterials" or "bioprocessing of materials".

•  Detailed work on many terms is still required

•  Require input to address these broader aspects of nanomanufacturing e.g. supply/value chain relationships, relative efficiency

•  Looking for industrial experts to contribute to the final drafting process.

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DateXXXX 36 Copyright © 2010 Standards Australia Limited

Films, Coatings and Membranes

New Work Item Proposal on Films, Coatings and Membranes

  Currently being developed by Germany

  Relevant to multiple industry sectors

  Challenging scope - Integrates with work on definitions related to nano-objects

  Consideration given to jointly convened Task Group

  Need to consider relevant industry sectors

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DateXXXX 37 Copyright © 2010 Standards Australia Limited

Films, Coatings and Membranes

New Work Item Proposal on Films, Coatings and Membranes

Cena LG and Peters TM (2011) Characterization and Control of Airborne Particles Emitted During Production of Epoxy/Carbon Nanotube Nanocomposites, Journal of Occupational and

Environmental Hygiene, 8: 86–92

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DateXXXX 38 Copyright © 2010 Standards Australia Limited

Other Sectors, Applications and Domains

Member bodies are encouraged to develop and submit New Work Item Proposals

  Industry sectors relevant to Australia which involve nanotechnology

–  energy –  agriculture –  food –  water –  mineral resources –  manufacturing –  research –  information technology –  sport, leisure and entertainment –  retail and banking –  medical

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