NF EN ISO 10993-18 : 2009
Withdrawn
View Superseded by
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
01-12-2013
11-09-2021
Avant-propos
Introduction
1 Domaine d'application
2 Références normatives
3 Termes et définitions
4 Symboles et termes abrégés
5 Principes généraux
6 Mode opératoire de caractérisation
7 Paramètres et méthodes de caractérisation chimique
8 Rapport relatif aux données recueillies
Annexe A (normative) - Diagramme résumant les étapes de
génération des données de caractérisation
chimique à utiliser pour l'évaluation toxicologique
des risques
Annexe B (informative) - Sources d'information pour la
caractérisation chimique
Annexe C (informative) - Principes pour juger de
l'équivalence toxicologique
Bibliographie
Specifies a framework for the identification of a material and the identification and quantification of its chemical constituents. The chemical characterization information generated can be used for a range of important applications.
| DevelopmentNote |
Indice de classement: S99-501-18. PR NF EN ISO 10993-18 April 2003. (04/2003) PR NF EN ISO 10993-18 February 2009. (02/2009)
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| DocumentType |
Standard
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| PublisherName |
Association Francaise de Normalisation
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| Status |
Withdrawn
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| SupersededBy |
| Standards | Relationship |
| ISO 10993-18:2005 | Identical |
| NBN EN ISO 10993-18 : 2009 | Identical |
| BS EN ISO 10993-18:2009 | Identical |
| NS EN ISO 10993-18 : 2009 | Identical |
| DIN EN ISO 10993-18:2009-08 | Identical |
| EN ISO 10993-18:2009 | Identical |
| I.S. EN ISO 10993-18:2009 | Identical |
| NEN EN ISO 10993-18 : 2009 | Identical |
| UNE-EN ISO 10993-18:2009 | Identical |
| 2007/47/EC : 2007 COR 1 2015 | DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE) |
| ISO 10993-17:2002 | Biological evaluation of medical devices — Part 17: Establishment of allowable limits for leachable substances |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |