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EVS-EN ISO 10993-5:1999

Biological evaluation of medical devices - Part 5: Tests for cytotoxicity - in vitro methods

General information

Withdrawn from 07.08.2009
Base Documents
ISO 10993-5:1999; EN ISO 10993-5:1999
ICS Groups
11.100 Laboratory medicine
Directives or regulations
None

Standard history

Status
Date
Type
Name
07.08.2009
Main
EVS-EN ISO 10993-5:2009
Main
EVS-EN ISO 10993-5:1999
This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices.  These methods specify the incubation of cultured cells either directly or trough diffusion  a) with extracts of a device , and/or b) in contact with a device.  These methods are designed to determine the biological response of mammalian cells in vitro using appropriate biological parameters.

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Standard monitoring
English (PDF 196 KB)

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English