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EVS-EN ISO 10993-3:2014

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:2014)

General information

Valid from 07.11.2014
Base Documents
ISO 10993-3:2014; EN ISO 10993-3:2014
ICS Groups
11.100.20 Biological evaluation of medical devices
Directives or regulations
90/385/EEC Active implantable medical devices 93/42/EEC Medical devices (MDD)

Standard history

Status
Date
Type
Name
07.11.2014
Main
EVS-EN ISO 10993-3:2014
07.08.2009
Main
EVS-EN ISO 10993-3:2009
This part of ISO 10993 specifies strategies for risk estimation, selection of hazard identification tests
and risk management, with respect to the possibility of the following potentially irreversible biological
effects arising as a result of exposure to medical devices:
genotoxicity;
carcinogenicity;
reproductive and developmental toxicity.
This part of ISO 10993 is applicable when the need to evaluate a medical device for potential genotoxicity,
carcinogenicity, or reproductive toxicity has been established.
NOTE Guidance on selection of tests is provided in ISO 10993-1.

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Standard monitoring
English (PDF 226 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