NF EN ISO 10993-9
NF EN ISO 10993-9

NF EN ISO 10993-9

January 1999
Standard Cancelled

Biological evaluation of medical devices. Part 9 : framework for identification and quantification of potential degradation products.

Le présent document fournit les principes généraux relatifs à l''évaluation systématique de la biodégradation potentielle des dispositifs médicaux.

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Main informations

Collections

National standards and national normative documents

Publication date

January 1999

Number of pages

17 p.

Reference

NF EN ISO 10993-9

ICS Codes

11.040.01   Medical equipment in general
11.100.20   Biological evaluation of medical devices

International kinship

ISO 10993-9:1999

European kinship

EN ISO 10993-9:1999
Sumary
Biological evaluation of medical devices. Part 9 : framework for identification and quantification of potential degradation products.

Le présent document fournit les principes généraux relatifs à l''évaluation systématique de la biodégradation potentielle des dispositifs médicaux.
Standard replaced by (1)
NF EN ISO 10993-9
NF EN ISO 10993-9
January 2009
Standard Cancelled
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:1999)

Le présent document fournit les principes généraux relatifs à l''évaluation de la biodégradation potentielle des dispositifs médicaux ainsi qu''à la conception et la qualité des études de biodégradation. Les normes de la série NF EN ISO 10993 sur l''évaluation biologique des dispositifs médicaux ont le statut de normes harmonisées et viennent en appui aux Directives européennes sur les dispositifs médicaux. Les Directives 93/42/CE sur les dispositifs médicaux et 90/385CE sur les dispositifs médicaux implantables actifs ayant été modifiées par la Directive 2007/47/CE une nouvelle version des annexes ZA et ZB donnant les correspondances entre les chapitres de la norme et les exigences essentielles des Directives modifiées a été élaborée. Ces nouvelles versions des annexes ZA et ZB sont intégrées dans le présent document.

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