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SSH EN ISO 10993-18:2007

Vlerësimi biologjik i pajisjeve mjekësore - Pjesa 18: Karakterizimi kimik i materialeve

Biological evaluation of medical devices - Part 18: Chemical characterization of materials (ISO 10993-18:2005)
1 jan 2007
95.99 Withdrawal of Standard   17 qer 2009

General information

95.99     17 qer 2009

DPS

DPS/KT 206

European Norm

11.100  

anglisht  

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Scope

This document describes a framework for the identification and, where necessary, quantification of the chemical constituents of a material to provide information required for inclusion in an assessment of the biological safety of medical devices. This part of ISO 10993 does not address the identification or quantification of degradation products, which are covered in ISO 10993 part 9, 13, 14 and 15. ISO 10993-18 is intended for suppliers of materials and manufacturers of medical devices, when carrying out a biological safety assessment.

Related directives

Directives related to this standards.

90/385/EEC

Pajisjet mjekësore aktive transplatuese

Të harmonizuara
93/42/EEC

Pajisje Mjekësore

Life cycle

PREVIOUSLY

PUBLISHED
SSH EN ISO 10993-18:2009

NOW

WITHDRAWN
SSH EN ISO 10993-18:2007
95.99 Withdrawal of Standard
17 qer 2009

Related project

Adopted from EN ISO 10993-18:2005