Standard

NS-EN ISO 10993-18:2005

Nov 2005 Withdrawn

Note: This standard has a new edition: NS-EN ISO 10993-18:2020

Corrigendums and amendments are bought separately.

Language English

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Abstract

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.

Document information

Standard from SN
Published: 1 November 2005
Withdrawn: 1 July 2009
Edition: 2005-07
Version: 1
Document type: NAT
ISBN:

ICS 11.100
ICS 11.100.20
National Committee SN/K 115

Legal references

EU law: 90/385/EEC, 93/42/EEC

Product Relations

Replaced by: NS-EN ISO 10993-18:2009
Adopted from: EN ISO 10993-18:2005 , 0

Product life cycle

Current product

Withdrawn

NS-EN ISO 10993-18:2005
Replaced by

Withdrawn

NS-EN ISO 10993-18:2009

NS-EN ISO 10993-18:2005

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NS-EN ISO 10993-18:2020

NS-EN ISO 10993-18:2009