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

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

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

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.

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.

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

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

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

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 80004 consists of the following parts under the general title: Nanotechnologies – Vocabulary:

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

Nanotechnologies: Terminology and Nomenclature ISO/TS 8004-1: 2010 Nanotechnologies – Vocabulary – Part 1: core terms Published 2010 ISO/TS 27687:2008 will be ISO/TS 8004-2 Terminology and definitions for nano-objects – Nanoparticle, nanofibre and nanplate. Vocabulary – Part 2 in next edition Published 2008 New edition In Progress ISO/TS 8004-3: 2010 Nanotechnologies – Vocabulary – Part 3: Carbon Nano-objects ISO/TS 8004-4: 2010 Nanotechnologies – Vocabulary – Part 4: Nanostructured materials Published 2011 ISO/TS 8004-5: 2010 Nanotechnologies – Vocabulary – Part 5: Nano/bio interface ISO/TS 8004-6: 2010 Nanotechnologies – Vocabulary – Part 6: Nanoscale measurments and instrumentation Work in progress ISO/TS 8004-7: 2010 Nanotechnologies – Vocabulary – Part 7: Diagnostics and therapeutics for healthcare ISO/NP TS 8004-8: 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 17302 2010 Nanotechnologies-Framework for identifying vocabulary development for nanotechnology applications in human healthcare

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

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 12885 :2018 Nanotechnologies – Health and safety practices in occupational settings relevant to nanotechnologies Published 2008 ISO/DTS 12901-1 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

Nanotechnologies: Material Specification ISO/DTS 11931-1 Nanotechnologies - Nano–calcium carbonate –Part 1: Characterisation and measurement methods Soon to publish 2012 ISO/DTS 11937-1 Nanotechnologies – Nano-titanium dioxide –Part 1: Characterisation and measurement methods ISO/TS 12805: 2011 Nanotechnologies – Materials specifications _ Guidance on specifying nano-objects Published 2011

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)

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

Thank you for attention