Standard

NS-EN ISO 10993-5:2009

Sept 2009 Published

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Standard

NS-EN ISO 10993-5:2009
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:2009)

Sept 2009 Published
Standard

NS-EN ISO 10993-5:1999
Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity (ISO 10993-5:1999)

Sept 1999 Withdrawn

Abstract

ISO 10993-5:2009 describes test methods to assess the in vitro cytotoxicity of medical devices.These methods specify the incubation of cultured cells in contact with a device and/or extracts of a device either directly or through diffusion.These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.

Document information

Standard from SN
Published: 1 September 2009
Edition: 2009-06
Version: 1
Document type: NAT
ISBN:

ICS 11.100.20
National Committee SN/K 115

Legal references

EU law: 93/42/EEC, 90/385/EEC, 2007/47/EC

Product Relations

Referred by: NS-EN ISO 4074:2015
Replaces: NS-EN ISO 10993-5:1999
Adopted from: EN ISO 10993-5:2009 , 0

Product life cycle

Previous product

Withdrawn

NS-EN ISO 10993-5:1999
Current product

Published

NS-EN ISO 10993-5:2009

Amendments

Published

NS-EN ISO 10993-5:2009/A11:2025

NS-EN ISO 10993-5:2009

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