Analysis of technical standards in the field of nanotechnology

Nanotechnology Law and Business

Volumn 7, Issue 3, 2010, Pages 299-307

  Violet, Franck ^a  

^a UNIVERSITÉ DE LYON   (France)

Author keywords

[No Author keywords available]

Indexed keywords

INFORMATION RELAY; INTERNATIONAL STANDARDIZATION; NEW SCIENCE; OVERLAPPING AREA; TECHNICAL STANDARDS; WORKING GROUPS;

LAWS AND LEGISLATION; STANDARDIZATION;

NANOTECHNOLOGY;

EID: 78649406300     PISSN: 15462080     EISSN: 15462080     Source Type: Journal    
DOI: None     Document Type: Article

References (28)

1. But see Daniel Bernard, La Terminologie Des Nanotechnologies Au Coeur Des Processus Normatifs" (The Jargon of Nanotechnology: At the Heart of Naming Processes), RÉALITÉS INDUSTRIELLES (INDUSTRIAL REALITIES) 48 (2010);
2. See also Franck Violet, The Intersection Between Technical Standards and Invention Patents in the Field of Nanotechnologies, NANONORMA SYMPOSIUM IN PARIS (Oct. 7, 2009).
3. See e.g., NF X 50-003 (Aug. 1997), on file with author.
4. See Int'l Org. for Standards, Under Development, ISO/NP TS 11931-2: Nanotechnologies - Nano-calcium carbonate - Part 2: Specifications in Selected Application Areas (2009), available at http://www.iso.org/iso/catalogue-detail. htm?csnumber=52826.
5. See Int'l Org. for Standards, Under Development, ISO/NP TS 11937-2: Nanotechnologies - Nano-titanium dioxide - Part 2: Specifications in Selected Application Areas (2009), available at http://www.iso.org/iso/catalogue-detail. htm?csnumber=52828.
6. See Int'l Org. for Standards, ISO/TR 11360:2010: Nanotechnologies - Methodology for the classification and categorization of nanomaterials (2009), available at http://www.iso.org/iso/catalogue-detail.htm?csnumber=55967.
7. See Int'l Org. for Standards, Home, http://ww.iso.org (last visited Sept. 26, 2010) (exhaustive and regularly updated list).
8. See e.g., Commission Particulière du Débat Public Nanotechnoogies, Home Page, http://cpdp.debatpublic.fr/cpdp-nano (last visited Sept. 26, 2010).
9. For example, Article 84 of the European Patent Court requires that an inventor state clearly expressed claims, however, this is not the present view adopted by the EPO. See e.g., Yves Verbandt, Quelle Régulation pour les Nanosciences et les Nanotechnologies ?" (What Regulations are Needed for Nanosciences and Nanotechnologies?), EPO PRESENTATION AT THE DOMAINE DU TREMBLAY Conference (2009).
10. In December 2003, China also set up a "United working group", with the objective of standardising nanomaterials. See e.g., Peter Hatto, International Standardization for Nanotechnologies, PRESENTATION AT MICHIGAN STATE UNIVERSITY (2007), available at http://sei.nnin.org/doc/resource/ Presentation-International-Standardization-for-Nanotechnologies.pdf.
11. Eur. Committee for Standardization, BT resolution C005/2004. See generally Eur. Committee for Standardization, Nanotechnologies, http://www.cen.eu/cen/Sectors/Sectors/Nanotechnologies/Pages/default.aspx (last visited Sept. 26, 2010).
12. See Int'l Org. for Standards, Home, http://ww.iso.org (last visited Sept. 26, 2010) (for details of the work progress made by this technical committee).
13. See Int'l Org. for Standards, ISO/TS 27687:2008, Nanotechnologies -Terminology and Definitions for Nano-Objects -Nanoparticle, Nanofibre and Nanoplate (2009), available at http://www.iso.org/iso/catalogue-detail?csnumber= 44278
14. In its corrected version of Feb. 1, 2009.
15. In most cases, the terms used are derived from the format used for normal objects. Only the measurement values differ, as we are considering the infinitely small. The size thus leads to the addition of the prefix "nano".
16. Atomic force close field microscopy, spectroscopy and ellipsometry can also be used.
17. See e.g., NF EN 12683, BIOTECHNOLOGIE - ORGANISMES MODIFIES DISSEMINES DANS L'ENVIRONNEMENT - GUIDE POUR LA CARACTERISATION DE L'ORGANISME GENETIQUEMENT MODIFIE PAR L'ANALYSE DE LA STABILITE MOLECULAIRE DE LA MODIFICATION GENOMIQUE, (BIOTECHNOLOGY - MODIFIED ORGANISMS DISSEMINATED IN THE ENVIRONMENT - GUIDE FOR DEFINING GENETICALLY MODIFIED ORGANISMS BY ANALYSING THE MOLECULAR STABILITY OF THE GENOMIC MODIFICATION) (Dec. 1998)
18. XP X33-017, CARACTERISATION DES BBOUES - DENOMBREMENT ET VIABILITE DES OEUFS D'HELMINTHES PARASITES - METHODE PAR UNE TECHNIQUE DE TRIPLE FLOTTATION, (DEFINING SLUDGE - COUNTING AND VIABILITY OF PARASITE HELMINTH EGGS - METHOD USING A TRIPLE FLOTATION TECHNIQUE) (July 2004).
19. This assumes the selection of an appropriate measurement unit to express the dose/effect relationship. See also Nanosm;)e: Safety in Nanomaterials, Home Page, http://www.nanosmile.org (last visited Sept. 26, 2010).
20. See ISO/TS 27687:2008, supra note 12.
21. At the present time, only OECD guidelines exist.
22. For a comprehensive approach to ISO work in this field, see the ISO Website, and especially the pages concerning TC 229. See Int'l Org. for Standards, TC 229: Nanotechnologies, http://www.iso.org/iso/iso-catalogue/ catalogue-tc/catalogue-tc-browse.htm?commid=381983 (last visited Sept. 26, 2010).
23. See EUR. COMMISSION COMMUNICATION, TOWARDS A EUROPEAN STRATEGY FOR NANOTECHNOLOGY 338, 345 (2004).
24. See Franck Violet, Articulation Entre la Norme Technique et la Règle de Droit, (Relationship Between Technical Standards and Legal Requirements), PUAM 131 (2003) (for a more precise approach to this role of the technical standard).
25. Certification may be either national or for the European Community.
26. In our view, it would also be possible to use standards relating to user manuals, technical data sheets or marking and so forth.
27. This assumption does not exclude the case in which the product, compliant with the contractually incorporated technical standard, may be defective. For example, a product that is dangerous because it contains manufactured nanoparticles, even though it may respect the limit values stipulated by the standard.
28. See Violet, supra note 22 (for a precise analysis of the legal impact of compliance with a non-mandatory technical standard).