1. Nano–biotechnology PL 2012
NANOTECHNOLOGIES ─ STANDARDISATION ISSUES
Maria Zielecka
Instytut Chemii Przemysłowej im. prof. Ignacego Mościckiego
17-18 September, Warsaw

2. OUTLINE Introduction Technical Committees Terminology
Standards/documents published and under development
5. Concluding remarks

3. INTRODUCTION
As many authorities predict the applications of nanotechnologies will change all areas of life and will enable dramatic advances to be realized in all areas of communication, health, manufacturing, materials and knowledge-based technologies.
Due to these facts there is an obvious need to provide industry and research the suitable tools to aid the development and application of those technologies.
Moreover, the reliable measurement systems and evaluation protocols supported by well-founded and robust standards are needed for regulator and health and environmental protection agencies

4. Technical committees focused on
standards concerning nanotechnology - international
The answer on the development of nanotechnology was the establishment of the following technical Commitees:
Technical Committee ISO/TC 229 Nanotechnology — the International Organisation for Standardization ISO
Technical Committee TC113 — International Electrotechnical Commission
Technical Committee CEN/TC 352 — European Committe for Standardisation
These TC’s are working closely according to the Vienna Agreement.

5. Technical committee focused on
standards concerning nanotechnology – in Poland
In Poland the normalisation in the area of nanotechnology until 30 December 2011, dealt with two technical committees:
TC 207- Material Removal and Accretion Machining Processes and Surface Layer Characteristic
KT 60 - Semiconductor Power Converters
Increasing need of standardization in the field of nanotechnology in Technical Committee 207 justified the launch of the establishment of the technical committee especially focused on nanotechnologies.
As a result of these actions, on 30 December 2011, Technical Committee 314 Nanotechnology was appointed, which took over responsibility for the standardization work carried out in the Technical Committee 207 in the field of nanotechnology.

6. The scope of Technical Committee 314
TC 314 scope includes issues relating to the matter and processes at the nanoscale, typically, but not exclusively, of dimension less than 100 nm in one or more directions, where the properties depend on the dimensions enable new applications, use the properties of materials at the nanoscale to produce:
improved materials, equipment and systems using these new features,
terminology and nomenclature,
metrology and instrumentation, including specifications for reference materials,
research methodologies,
modelling and simulation,
health safety and environmental protection

7. Terminology in nano area
ISO/TC 27687:2008
Nanotechnologies ─ terminology and definitions for nanobjects
Nanoparticle, nanofibire, nanoplate

8. Hierarchy of terms releted to nanobjects
ISO/TC 27687:2008
Nanotechnologies ─ terminology and definitions for nanobjects
Nanoparticle, nanofibire, nanoplate

9. IEC/TS 80004- 1-10 IEC/TS 80004 was prepared by Technical Committee
ISO/TC 229 and IEC/TC 113 , Nanotechnology standardization for electrical and electronics products and systems in a Joint Working Group JWG 1
IEC/TS consists of the following parts under the general title: Nanotechnologies – Vocabulary:

10. Number of published standards/documents
and standards/documents under development

11. Nanotechnologies: Terminology and Nomenclature
ISO/TS : 2010
Nanotechnologies – Vocabulary – Part 1: core terms
Published 2010
ISO/TS 27687:2008 will be ISO/TS
Terminology and definitions for nano-objects – Nanoparticle, nanofibre and nanplate. Vocabulary – Part 2 in next edition
Published 2008
New edition In Progress
ISO/TS : 2010
Nanotechnologies – Vocabulary – Part 3: Carbon Nano-objects
ISO/TS : 2010
Nanotechnologies – Vocabulary – Part 4: Nanostructured materials
Published 2011
ISO/TS : 2010
Nanotechnologies – Vocabulary – Part 5: Nano/bio interface
ISO/TS : 2010
Nanotechnologies – Vocabulary – Part 6: Nanoscale measurments and instrumentation
Work in progress
ISO/TS : 2010
Nanotechnologies – Vocabulary – Part 7: Diagnostics and therapeutics for healthcare
ISO/NP TS : 2010
Nanotechnologies – Vocabulary – Part 8: Nanomanufacturing processes
ISO/TR 11360: 2010
Methodology for classification and categorization of nanomaterials
ISO/TR 12802: 2010
Model taxonomic framework for use in developing vocabularies
ISO/NP TR
Nanotechnologies-Framework for identifying vocabulary development for nanotechnology applications in human healthcare

12. Nanotechnologies: Measurement and Characterization
ISO/PRF TS 10797
Nanotechnologies – Charcterization of single-wall carbon nanotubes using TEM
Soon to publish 2012
ISO/TS 10798:2011
Nanotechnologies – Charcterization of single-wall carbon nanotubes using SEM and EDS
Published 2011
ISO/TS 10867:2010
Nanotechnologies – Charcterization of single-wall carbon nanotubes usingnear IR photoluminescence spectroscopy
Published 2010
ISO/TS 10868:2011
Nanotechnologies – Charcterization of single-wall carbon nanotubes using UV-Vis-NIR absorption spectroscopy
ISO/TR 10929:2012
Nanotechnologies – Charcterization of single-wall carbon nanotube samples
Published 2012
ISO/TS 11251:2010
Nanotechnologies – Charcterization of volatile components in single-wall carbon nanotubes usingevolved gas analysis/gas chromatograph-mass spec.
ISO/TS 11308:2011
Nanotechnologies – Charcterization of single-wall carbon nanotubes usingthermogravimetric analysis
ISO/TS 11888:2011
Nanotechnologies – Charcterization of multiwall carbon nanotubes - Mesoscopic shape factors
ISO/TS 13278:2011
Nanotechnologies – Determination of elemental impurities in samples of carbon nanotubes using inductively coupled plasma mass spectrometry
ISO/DIS 12025
Nanotechnologies – Quantification of nano-objects release from powders by generation of aerosols

13. Nanotechnologies: Health, Safety and Environment
ISO 29701: 2010
Nanotechnologies – Endotoxin test on nanomaterial samples for in vitro systems – Limulus amebocyte lysate test
Published 2010
ISO 10801: 2010
Nanotechnologies – Generation of metal nanoparticles for inhalation toxicity testing using the evaporation /condensation method
ISO 10808: 2010
Nanotechnologies – Characterisation of nanoparticles in inhalation exposure chambers for inhalation toxicity testing
ISO/TR :2018
Nanotechnologies – Health and safety practices in occupational settings relevant to nanotechnologies
Published 2008
ISO/DTS
Nanotechnologies – Guidlines for occupational risk management applied to engineered nanomaterials-Part 1: Principles and approaches + Part 2: Use of the control banding approach
Soon to publish 2013
ISO/TR 13014:
2012
Nanotechnologies – Guidance on physico-chemical characterization of engineered nanoscale materials for toxological assessement
Published 2012
ISO/TR 13121:
2010
Nanotechnologies – Nanomaterials risk evaluation
Published 2011

14. Nanotechnologies: Material Specification
ISO/DTS
Nanotechnologies - Nano–calcium carbonate –Part 1: Characterisation and measurement methods
Soon to publish
2012
ISO/DTS
Nanotechnologies – Nano-titanium dioxide –Part 1: Characterisation and measurement methods
ISO/TS 12805:
2011
Nanotechnologies – Materials specifications _ Guidance on specifying nano-objects
Published 2011

15. CEN/TC 352 – Published standards
CEN ISO/TS 27687:2009
Nanotechnologies - Terminology and definitions for nano-objects - Nanoparticle, nanofibre and nanoplate (ISO/TS 27687:2008)
EN ISO 10801:2010
Nanotechnologies - Generation of metal nanoparticles for inhalation toxicity testing using the evaporation/condensation method (ISO 10801:2010)
EN ISO 10808:2010
Nanotechnologies - Characterization of nanoparticles in inhalation exposure chambers for inhalation toxicity testing (ISO 10808:2010)
EN ISO 29701:2010
Nanotechnologies - Endotoxin test on nanomaterial samples for in vitro systems - Limulus amebocyte lysate (LAL) test (ISO 29701:2010)

16. Concluding remarks
The need for standardization still exists in various fields of nanotechnology in order to support commercialization and market development, provide a basis for procurement, and support appropriate legislation/regulation.
The effort should be focused on:
internationally agreed terminology/definitions for nanotechnology
internationally agreed protocols for toxicity testing of nanoparticles
standardized protocols for evaluating environmental impact of nanoparticles
standardized measurement techniques and instruments no standardized calibration procedures and certified references materials

17. Thank you for attention