NF EN ISO 10993-18 : 2009
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 18: CHEMICAL CHARACTERIZATION OF MATERIALS
09-11-2021
12-01-2013
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Withdrawn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 |
| UNI EN ISO 10993-18 : 2009 | Identical |
| NBN EN ISO 10993-18 : 2009 | Identical |
| SN EN ISO 10993-18 : 2009 | Identical |
| ONORM EN ISO 10993-18 : 2009 | Identical |
| BS EN ISO 10993-18:2009 | Identical |
| UNE-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 |
| 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 |
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