EN 30993-3:1993

Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity (ISO 10993-3:1992)

Publication date:   Oct 23, 2003

General information

99.60 Withdrawal effective   Oct 15, 2003

CEN

CEN/TC 206 Biological and clinical evaluation of medical devices

European Norm

11.040.01   Medical equipment in general | 11.060.10   Dental materials | 11.120.01   Pharmaceutics in general

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Scope

This part of ISO 10993 specifies tests for the following biological aspects: - genotoxicity, - carcinogenicity; and - reproductive and developmental toxicity. These are relevant in the biological evaluation of some categories of medical and dental materials and devices (see note). Guidance on selection of tests is provided in ISO 10993-1. Where the need for the evaluation of the potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified, they should be evaluated in accordance with this part of ISO 10993. Most tests included in this part of the International Standard refer to the OECD guidelines for testing of chemicals. Reference to these tests is made by the term 'OECD guideline(s)' followed by the appropriate test number(s). At the time of testing, these tests are to be performed according to current OECD guidelines. Note: The term 'devices' corresponds to the definition given in ISO 10993-1 and covers materials, as well as dental materials and devices. The definition is in accordance with the CEN standard document.

Related legislation

Legislation related to this standard

90/385/EEC

Active implantable medical devices

Harmonized/Supporting
93/42/EEC

Medical devices

Harmonized/Supporting

Life cycle

NOW

WITHDRAWN
EN 30993-3:1993
99.60 Withdrawal effective
Oct 15, 2003

REVISED BY

WITHDRAWN
EN ISO 10993-3:2003

Relations

Adopted from ISO 10993-3:1992 IDENTICAL