ISO 10993-3:2003
Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

Standard No.

ISO 10993-3:2003

Release Date

2003

Published By

International Organization for Standardization (ISO)

Status

Withdraw

Replace By

ISO 10993-3:2014

Latest

ISO 10993-3:2014

Scope

This part of ISO 10993 specifies strategies for hazard identification and tests on medical devices for the following biological aspects: — genotoxicity, — carcinogenicity, and — reproductive and developmental toxicity. This part of ISO 10993 is applicable for evaluation of a medical device whose potential for genotoxicity, carcinogenicity or reproductive toxicity has been identified. NOTE Guidance on selection of tests is provided in ISO 10993-1.

ISO 10993-3:2003 Referenced Document

• ISO 10993-12:2002 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
• ISO 10993-1:1997 Biological evaluation of medical devices - Part 1: Evaluation and testing
• ISO 10993-2:1992 Biological evaluation of medical devices; part 2: animal welfare requirements
• ISO 10993-6:1994 Biological evaluation of medical devices - Part 6: Tests for local effects after implantation

ISO 10993-3:2003 history

• 2014 ISO 10993-3:2014 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
• 2003 ISO 10993-3:2003 Biological evaluation of medical devices - Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
• 1992 ISO 10993-3:1992 Biological evaluation of medical devices — Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity