1. Nanotechnology Standardization, National and International
In the Name of God
Nanotechnology Standardization, National and International
Activities, Challenges Ahead
Ali Beitollahi1,2
1 Director of Nanostandardization and International Collaboration Committee, Iran Nanotechnology Initiative Council (INIC).
2Center of Excellence for Ceramics in Energy and Environment, School of Materials, Iran University of Science and Technology (IUST), Narmak, Farjam, Tehran, Iran.

2. Contents of my Talk
Nanostandardization
International Activities
Iran’s Activities
Iran Nanosafety Network, Structure and Activities.
Nano Mark Scheme.

3. Why Nanostandardization?
To support commercialisation and market development.
To provide a basis for procurement through technical requirements, and quality and environmental management.
To support voluntary governance structures and appropriate legislation and regulation.
Current Challenges
-Lack of internationally agreed terminology/definitions.
-Lack of internationally agreed protocols for toxicity testing.
-Lack of standardized protocols for evaluating environmental impact.
-Existing “methods of test” might not be suitable for nanoscale devices and nanoscale dimensions.
-Measurement techniques and instruments need to be developed and/or standardized.
-New calibration procedures and certified references materials are needed for validation of test instruments at the nanoscale.
-Multifunction nanotechnology systems and devices will need new standards.
Partial solutions
-Some existing standards are or might be applicable

4. International Activities ISO/TC 229 - Nanotechnologies
Established in June 2005
46 members – 35 “P” and 11 “O”
P members: Australia ( SA ), Austria ( ON ), Belgium ( NBN ), Brazil ( ABNT ), Bulgaria(BDS), Canada ( SCC ), China ( SAC ), Czech Republic ( UNMZ ), Denmark ( DS ), Finland ( SFS ), France ( AFNOR ), Germany ( DIN ), Greece(ELOT), India ( BIS ), Indonesia(BSN), Iran, Islamic Republic of ( ISIRI ), Irland(NSAI), Israel ( SII ), Italy ( UNI ), Japan ( JISC ), Kenya ( KEBS ), Korea, Republic of ( KATS ), Malaysia ( DSM ), Mexico ( DGN ), Netherlands ( NEN ), Norway ( SN ), Poland ( PKN ), Russian Federation ( GOST R ), Singapore ( SPRING SG ), South Africa ( SABS ), Spain ( AENOR ), Sweden ( SIS ), Switzerland ( SNV ), USA ( ANSI ), UK (BSI),
O members: Argentina ( IRAM ), Egypt ( EOS ), Estonia ( EVS ) , Hong Kong, Kazakhstan ( KAZMEMST ), Morocco (IMANOR ), Romania ( ASRO ), Serbia ( ISS ), Serilanka(SLSI), Thailand ( TISI ),
Liaisons with 16 other ISO TCs and 9 external bodies – IEC/TC 113, CEN/TCs 137 and 352, Asia Nano Forum, BIPM, EC JRC, OECD , IUPAC and VAMAS
Exploring additional external liaisons for other groups (e.g. International Alliance for Nano EHS Harmonization) and for emerging economies

6. Liaisons MATERIALS BIOMEDICAL ENERGY EXTERNAL LIAISONS RISK/HS&E
ISO/TC 107
Metallic and other inorganic coatings
ISO/TC 38
Textiles
ISO/TC 206
Fine ceramics
ISO/TC 122
Packaging
ISO/TC 119
Powder metallurgy
ISO/TC 91
Surface active agents
ISO/TC 84
Devices for administration of medical products and intravascular catheters
MATERIALS
BIOMEDICAL
ISO/TC 61
Plastics
Liaisons
ENERGY
ISO/TC 168
Prosthetics and orthotics
ISO/TC 212
Clinical laboratory testing and in vitro diagnostic test systems
ISO/TC 215
Health Informatics
ISO/TC 225
Market opinion and social research
Environmental management
ISO/TC 28
Petroleum and petroleum products
ISO/TC 180
Solar energy
ISO/TC 203
Technical energy systems
ISO/TC 184
Industrial automation systems and integration
ISO/TC 172
Optics and photonics
ISO/TC150
Implants for surgery
ISO/TC 217
Cosmetics
ISO/TC 34
Food products
ISO/TC 48
Laboratory equipment
NANO-PARTICLES
METROLOGY AND
CHARACTERIZATION
EXTERNAL LIAISONS
RISK/HS&E
BIPM
ISO/TC 142
Cleaning equipment for air and other gases
ISO/TC 59
Building construction
ISO/TC 35
Paints and varnishes
ISO/TC 45
Rubber and rubber products

7. TC 229 – Structure/working areas
Material Specifications (WG4)
(Convened by China)
Terminology and Nomenclature (JWG 1)
“what you call it” - Convened by Canada
Measurement and Characterization (JWG 2)
“How you measure/test it” – Convened by Japan
Health, Safety and Environment (WG 3)
“what effect it might have on health and the environment”
– Convened by USA

8. ISO/TC 229 JWG1: Current Work Programme
Framework and core terms
Base
Definitions
Terminology for the bio-nano interface
Nomenclature model
Nano-processes
Nanomaterials
Terminology and definitions for nano-objects – nanoparticle, nanofibre and nanoplate – published August 2008
Nanotechnologies
Terminology for carbon nanostructures
Nano-production
Terminology for nanostructured materials
Terminology - nanofabrication
Nanomaterials classification
Devices and applications
Nanomeasurement
Terminology for medical, health and personal care applications of nanotechnologies
Terminology for nanoscale measurement and instrumentation

9. ISO/TC 229 JWG1: Some of the published standards
Base definitions:
ISO/TR 12802:2010 Nanotechnologies -- Model taxonomic framework for use in developing vocabularies -- Core concepts
ISO/TS :2010 Nanotechnologies -- Vocabulary -- Part 1: Core terms
Nanomaterials:
ISO/TS 27687:2008 Nanotechnologies -- Terminology and definitions for nano-objects -- Nanoparticle, nanofibre and nanoplate
ISO/TS :2010 Nanotechnologies -- Vocabulary -- Part 3: Carbon nano-objects
ISO/TS :2011 Nanotechnologies -- Vocabulary -- Part 4: Nanostructured materials
ISO/TR 11360:2010 Nanotechnologies -- Methodology for the classification and categorization of nanomaterials

10. ISO/TC 229 JWG2: Draft Roadmap
Carbon Nano-Materials
Basic Character set
Purity Geometrical property
Morphology Dispersability Tube type
Advanced Character set
Electrical, Magnetic, Mechanical , Optical properties
Engineered
nanoparticles
Basic Character set
Purity Composition, Geometrical property, Sampling method.
Advanced Character set
Elemental structure, Chemical functionality,
Electrical, Magnetic, Mechanical , Optical properties
Coatings/
Nanostructured materials
Basic Character set
Geometrical property, Composition, Density
Advanced Character set
Electrical, Magnetic, Mechanical , Optical properties
Basic Metrology
Length, Depth, Force, Traceability, Definition of Measurand, Uncertainty
Interoperability
Support for WG3 activities

11. JWG2 : Some of the published Standards
ISO/TS 10797:2012 Nanotechnologies -- Characterization of single-wall carbon nanotubes using transmission electron microscopy
ISO/TS 10798:2011 Nanotechnologies -- Characterization of single-wall carbon nanotubes using scanning electron microscopy and energy dispersive X-ray spectrometry analysis
ISO/TS 11308:2011 Nanotechnologies -- Characterization of single-wall carbon nanotubes using thermogravimetric analysis
ISO/TS 10867:2010 Nanotechnologies -- Characterization of single-wall carbon nanotubes using
near infrared photoluminescence spectroscopy
ISO/TS 10868:2011 Nanotechnologies -- Characterization of single-wall carbon nanotubes using ultraviolet-visible-near infrared (UV-Vis-NIR) absorption spectroscopy

12. TC 229/WG3: Some of the published standards
ISO 10801:2010 Nanotechnologies -- Generation of metal nanoparticles for inhalation toxicity testing using the evaporation/condensation method
ISO 10808:2010 Nanotechnologies -- Characterization of nanoparticles in inhalation exposure chambers for inhalation toxicity testing
ISO/TR 12885:2008 Nanotechnologies -- Health and safety practices in occupational settings relevant to nanotechnologies
ISO/TR 13014:2012 Nanotechnologies -- Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment
ISO/TR 13121:2011 Nanotechnologies -- Nanomaterial risk evaluation
ISO 29701:2010 Nanotechnologies -- Endotoxin test on nanomaterial samples for in vitro systems -- Limulus amebocyte lysate (LAL) test

13. TC 229/WG3: Some of the Published Standards.
ISO/NP TR Nanotechnologies - Guidance on toxicological screening methods for manufactured nanomaterial
ISO/TS :2012 Nanotechnologies -- Occupational risk management applied to engineered nanomaterials -- Part 1: Principles and approaches
ISO/NP TS Nanotechnologies - Occupational risk management applied to engineered nanomaterials -- Part 2: Use of the control banding approach
ISO/TS Guidance on the labeling of manufactured nano-objects and products containing manufactured nano-objects
ISO/TR 13329:2012 Nanomaterials -- Preparation of material safety data sheet (MSDS)

14. TC 229/WG4: Some of the published standards
ISO/TS 12805:2011 Nanotechnologies -- Materials specifications -- Guidance on specifying nano-objects
ISO/TS Nanotechnologies -- Nano-calcium carbonate -- Part 1: Characteristics and measurement methods
ISO/TS Nanotechnologies -- Nano-titanium dioxide -- Part 1: Characteristics and measurement methods
ISO/TS Nanotechnology -- Nanoparticles in powder form -- Characteristics and measurements

15. International Electrotechnical Commission committee IEC/TC – “Nanotechnology standardization for electrical and electronic products and systems
Established June 2006 with US chair and German secretariat
29 members - 15 “P” and 14 “O”
Agreed to establish two Joint Working Groups with ISO TC/229:
JWG 1 – Terminology and nomenclature
JWG2 – Measurement and characterization
Together with a third Working Group:
WG3 – Performance assessment
Work Item: There are 17 underdevelopment projects in this committee which are related to electrical and electronic products and systems

16. European Committee for Standardization committee CEN/TC 352 - Nanotechnologies
Established November 2005 following a recommendation from CEN/BTWG 166
All 30 members of CEN are notionally members
Works closely with ISO/TC 229 using the ‘Vienna Agreement’ for cooperative working.
Developing a work programme to include areas of specific interest to Europe and areas that will be relevant to European legislation.

17. IEEE Nanotechnology Council
A multi-disciplinary group whose purpose is to advance and coordinate work in the field of Nanotechnology carried out throughout the IEEE in scientific, literary and educational areas. The Council supports the theory, design, and development of nanotechnology and its scientific, engineering, and industrial applications such as:
Aerospace & Electronic System Society (AES)
Antennas & Propagation Society (AP)
Circuits & Systems Society CAS)
Communications Society (COM)
Components, Packaging, & Manufacturing Technology Society (CPMT)
Computational Intelligence Society (CI) [Formerly Neural Networks (NN) Society]
Computer Society (C)
Control Systems Society (CS)
Electron Devices Society (ED

18. ASTM E56 Committee Formed in 2005.
This Committee addresses issues related to standards and guidance materials for nanotechnology & nanomaterials, as well as the coordination of existing ASTM standardization related to nanotechnology needs.
Published Standards by the Committee:
E Standard terminology Relating to Nanotechnology
E Standard Test Method for Analysis of Hemolytic Properties of Nanoparticles.
E Standard Test Method for Evaluation of the Effect of Nanoparticulate Materials on the Formation of Mouse Granulocyte- Macrophage Colonies.

19. Iran’s activities in nanostandardization
ISIRI/TC 229 mirror committee was established by INIC with cooperation of ISIRI (Institute of Standard & Industrial Research of Iran) in December 2006 comprised of 3 mirror working groups .
50 experts are member of the committee who are from various Universities, industry, research centers, ministry of health, ministry of agriculture and ISIRI.

20. Iran’s activities in nanostandardization
Published 15 national standards in the field of nanotechnology:
1- ISIRI 12963: Nanotechnologies-Analysis of hemolytic properties of nanoparticles.
2- ISIRI 12325: Nanotechnologies: Health and Safety in nano occupational setting-code of practice.
3- ISIRI 13566: Nanotechnologies- Evaluation of the effect of nanoparticulate materials on the formation of mouse granulocyte macrophage colonies-test method.

21. Iran’s activities in nanostandardization
4- ISIRI 14095: Nanotechnologies -- Characterization of single-wall carbon nanotubes using scanning electron microscopy and energy dispersive X-ray spectrometry analysis 5- ISIRI 14152Nanotechnologies -- Generation of metal nanoparticles for inhalation toxicity testing using the evaporation/condensation method
6-ISIRI Nanotechnologies -- Endotoxin test on nanomaterial samples for in vitro systems -- Limulus amebocyte lysate (LAL) test

22. Iran’s activities in nanostandardization
7- ISIRI 13731:Nanotechnologies -- Characterization of single-wall carbon nanotubes using near infrared photoluminescence spectroscopy
8- ISIRI 12098: Nanotechnologies- Vocabulary and main definitions
9- ISIRI 14564:Nanotechnologies -Characterization of single- wall carbon nanotubes using thermo gravimetric analysis
10- ISIRI 13736: Nanotechnologies-Safe packaging and transport of nanomaterials-code of practice

23. Iran’s activities in nanostandardization
11- Nanotechnologies -- Characterization of single-wall carbon nanotubes using ultraviolet-visible-near infrared (UV-Vis- NIR) absorption spectroscopy
12-Nanotechnologies-Methodogies for classification and categorization of nanomaterials
13- Guide to scanner and tip related artifacts in scanning tunneling microscopy and atomic force microscopy
14- nanotechnologies- Materials specification- Guidance on specifying nano-objects
15- Nanotechnologies – Characterization of multiwall carbon nanotubes– Mesoscopic shape factor

24. Iran’s activities in nanostandardization (Published 2 in ISO/TC229)
Iran acted as project leader of 3 international standard:
1-Nanotechnologies –Methodology for the Classification and
Categorization of Nanomaterials (ISO/TR 11360) .
2- Nanotechnologies- Determination of muramic acid as a biomarker for silver nanoparticles activity (In Publish Process)
3-Nanotechnologies: Vocabularies for Science, Technology and Innovation indicators (Under progress).

25. Aims/Activities: Established in 2012
Networking researchers, experts, research institutes and industrial units which are active in the field of EHS-related issues of nanotech .
Defining national priorities in direction with mission of nanosafety network with cooperation of other related national organization and centers.
Drafting national and international standards, Guidelines and Regulation in the filed of nano EHS.
Supporting the necessary hardware and software of the active member centers.
Supporting workshops, conferences in the relevant areas of activities.

26. Iran Nanotechnology Initiative Council
INSN Structure
INSN
Chairman of INSN
secretariat
Strategic committee
Occupational safety WG
Human Health WG
Environmental Safety WG
Nanoethics WG

27. Strategic committee
Strategic committee includes: 7 experts who are representatives from INIC, ministry of health, ministry of agriculture, ISIRI and universities,
Main tasks:
Compiling strategic program and developing policies for INSN.
Devising internal regulations
Supervising WGs activities
Reviewing proposals of WGs

28. Human Health WG: 12 experts, university professors and representatives from ministry of health Occupational safety WG: 7 experts from universities and research institutes active in the field of occupational health. Environment Safety: 12 experts who are representative from Department of Environment, ministry of Agriculture and from universities and research institutes in the filed of environmental-related aspects of nanotechnology. Nanoethics WG: 5 experts in the field of ethics and law and socio economic aspect on emerging technologies.

29. Some of the INSN Activities
Surveying national and international activities in the field of nanosafety, and other similar networks.
Capacity Building Activities: training and holding workshops and congress
Held the first national seminar “ safety and standardization in nanotechnology” on June 2012
Held a workshop on the safety of nanomaterial in human health and environment workshop. Aug
Supported 2 workshops held on “Nano safety issues in agriculture” Dec
Held training workshops: “Health and safety practices in laboratories working in the field of nanotech” Oct. 2013

30. Nano Mark Scheme To foster consumer trust and confidence.
Aims:
To foster consumer trust and confidence.
To boost market development.
To Facilitate marketing and trade.

31. Advantages Supporting sustainable growth of nano market.
Improvement of the quality of the products
Preventing frauds and misleading consumers.
Detecting local nanoproduct manufacturers and importers..
Implementing labeling regulations.

32. Nanomark system Standard Institute Iran Nanosafety Network
Property/Specifications assessment
Standard Institute
Iran Nanosafety
Network
Nanolab network
Nanoscale Audit
Nanomark
Ministry of
Agriculture
Tech-Market service corridor
INIC Standard Committee
Department of
Environment
Custom Duty
Ministry of Health

33. Acceptance Criteria: Nanomaterials/nanoproducts:
Size range of nanometers
Showing improvement of properties
Reproducibility
Note 1: Naturally occurring nano materials are not certified as nano products.
Note 2: Currently “Nano Mark” does not deal with environmental, health and safety (EHS) issues.

34. Assessment Body
Currently, department of inspection and examination of nano materials and nanoproducts unit is currently in charge of the entire assessment procedures and issuance of Nano Mark. Annual review and inspection is also carried out for the re-issue of the certificate. In 2014, this scheme is expected to be formally approved as a nationwide standard Mark.
Mandatory Aspects
The scheme is currently voluntary based. However, all of the start-ups, SMEs and large-scale manufacturers active in the field of nanotechnology to take advantage of various incentives, supports and services of INIC should apply for Nano Mark.
Costs
At the moment, INIC supports all of the related charges regarding the issue of Nano Mark.

35. Total No. of applications: 268 Total No. of approved products: 78

36. Future Plans
1- Implementing safety issues in Nano Mark subject to the development of the necessary standards.
2- Further development of a comprehensive labeling strategy in harmony with internationally agreed standards.
3- Fostering international collaboration to develop bilateral/multilateral joint Nano Mark scheme to boost mutual trade in our region and worldwide.
4- Planning for legal aspects of the Nano Mark.

37. Thank You for your Attention

38. ISO/TC 229 JWG1: Current Work Programme
Base Definitions
Nanomaterials
Devices and applications
Nanotechnologies
Nanoprocesses
Nanomanufacturing
Nanomeasurement

39. Standards for nanotechnologies
Further development of nanotechnology and commercializsation in an open, safe and responsible manner by supporting:
safety testing, legislation and regulation
worker, public and environmental safety
commercialisation and procurement
patenting and IPR
communication about the benefits, opportunities and potential problems associated with nanotechnologies
This will be possible by agreed ways of:
Naming, describing and specifying things
Measuring and testing things
Protocols for health and environmental safety testing, risk assessment and risk management

40. TC 229 published standards JWG2 (SWCNT work)
SEM + EDXA
TEM
UV-Vis-NIR absorption spectroscopy
NIR-PL
Spectroscopy
TGA
EGA-GCMS

41. JWG2 – published standards in MWCNT
Electrical characterization of Carbon Nanotubes (CNTs) Using 4-Probe Measurement (TS)
Measurement Methods for the Characterization
of Multi-Walled Carbon Nanotubes (TS)
Determination of meso-scopic shape factors of multiwalled carbon nanotubes (TS)

42. Dept. of Inspection (Nanoscale Audit Unit) .
INIC
Iran Nano FDA Committee
ISIRI/TC229
Dept. of Inspection
(Nanoscale Audit Unit) .
Iran Nanolab Network
Custom Duty
Nano Standardization Committee, Ministry of Agriculture

43. History: Nano Tech Promotion in Iran : 2001
Approval of National Plan: 2005
Establishment of Nanostandardization Committee: 2006
Establishment of Department of Inspection and Examination of Nano Materials and Nano Products: 2007

44. Standards Types of standards:
Metrological standards
Written standards
Written Standards provide agreed ways of:
Naming, describing and specifying things
Measuring and testing things
Managing things e.g. quality and environmental management: ISO 9001 and ISO 14000
To:
Support commercialisation, market development and established markets
Provide a basis for procurement
Support appropriate legislation/regulation
NORMATIVE, defining what MUST be done in e.g. a specific test
method, or INFORMATIVE, providing information only.
Standards are VOLUNTARY unless called in a contract or regulation.
Standards are based on CONSENSUS not necessarily unanimity

45. Standardization Standards can be:
FORMAL – developed by independent experts working under the auspices of a National, Regional or International standards body
AFNOR, BSI, DIN, JIS, ………………… (NSBs)
CEN, CENELEC, ETSI…..
ISO, IEC & ITU
INFORMAL – developed by a SDO (Standards Development Organisation)
ASTM, IEEE, SAE, SEMI, VDI
PRIVATE – developed by a company or trade association
FORMAL standards are:
PROPOSED, DEVELOPED AND APPROVED by the members of the standards body (or an accredited organisation)
Based on CONSENSUS (i.e. no sustained opposition), not necessarily unanimity.

46. Human Health WG priorities and main programs Scope of this WG includes: safety and health of naoproducts in the filed of foods, cosmetics, drugs, healthcare , medical devices and instruments. Main programs: In vivo and in vitro researches for evaluating the effects of nanomaterials in human and body response to these materials Characterization and measurement of nanomaterials in biological media. Studying the relation between physico-chemical properties of nanomaterials and some factors such as absorption, metabolism, distribution and excretion in human body. Studying the relation between physico-chemical properties of nanomaterials and diffusion of naomaterials to tissue and organs in the human body. How the human body responses to namaterials in molecular scale Studying the effects of nanomaterials on human health in different life stages.

47. Occupational safety priorities and programs
Scope of this WG includes: Human resources training, compiling standards and providing infrastructures in the field of occupational safety for laboratories and companies which are active in nanotechnology
Main program and activities:
Identifying groups who can be exposed to nanomaterials
Studying the effects of exposure on human with different types of nanomaterials.
Surveying risk and hazard evaluation, exposure assessment and designing new model and methods for risk assessment of nanomaterials.
Identifying and control the level of exposure with nanomaterials in deferent groups and media.

48. Environmental Health WG priorities and programs:
Scope of this WG includes: compiling standards, regulation and guidelines for environment and agriculture in the filed of nanotechnology:
Main programs:
life cycle analysis of nanomaterials.
Fate of nanmoaterials in environment.
Determining the factors which affect in transfer of nanomaterial to environment.
Risk management and developing new working framework
Effects of nanomaterials on ecosystems.

49. Nano Ethics WG
Scope of this WG includes: legitimating regulation and law, social acceptance of nanotechnology, ethics

50. Tech-Market Services Corridor
Nanoscale
Nanoscale Audit
Nanoscale
Global Marketing
Global Marketing
Technology level
Technology level
Technology level
Legal Advisory
Legal Advisory
Documentation
Documentation
Documentation
Local Marketing
Local Marketing
Patenting
Patenting
Patenting
Financing
Financing
Financing
Technology Monitoring
Technology Monitoring
Production Advisory
Technology Monitoring
Production Advisory
Production Advisory
Technology Transfer
Technology Transfer
Technology Transfer
Venture Capital
Venture Capital
Venture Capital
Technology Guaranty Fund
Technology Guaranty Fund
Standards & Certificates
Standards & Certificates
Technology Guaranty Fund
Standards & Certificates
Market Requirement
& Monitoring
Market Requirement
& Monitoring
Market Requirement
& Monitoring
Business Planning
Business Planning
Business Planning

51. Inspection of Nano Materials and Products Transparency of the Market
Higher Quality
Consumers’ Trust
Market Expansion
Transparency of the Market

52. Technical Evaluation Unit Referees and consultants
Structure of Department of Inspection
INIC
Steering Committee
Technical Manager
Technical Committee
Documentation Unit
Analysis and Inspection Unit
Technical Evaluation Unit
Referees and consultants

54. Other Activities:
Cooperation and close contacts with authoritative organizations involved in other areas such as healthcare (Iran Nano FDA) and agriculture.
Implementing quality management standard: ISO 9001.
Offering supportive services to certificate holders.
Preparing instructions for examining some nanoproducts for collaborating labs.
Offering the list of approved laboratories to manufacturers.