ISO 10993-1:1992
Biological evaluation of medical devices; part 1: guidance on selection of tests
- Standard No.
- ISO 10993-1:1992
- Release Date
- 1992
- Published By
- International Organization for Standardization (ISO)
- Status
- Replace By
- ISO 10993-1:1992/Cor 1:1992
- Latest
- ISO 10993-1:2018
- Scope
- This part of ISO 10993 gives guidance on a) the fundamental principles governing the biological evaluation of medical devices; b) the definition of categories of devices based on the nature and duration of contact with the body; c) the selection of appropriate tests. devices that do not come into contact with the patient’s body directly or indirectly. Nor does it cover biological hazards arising from any mechanical failure. Other parts of ISO 10993 cover specific tests as indicated in the foreword. (See A.2, clause 1 Scope.)
ISO 10993-1:1992 history
- 2018 ISO 10993-1:2018 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- 2010 ISO 10993-1:2009/Cor 11:2010 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process
- 2010 ISO 10993-1:2009/cor 1:2010 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process; Technical Corrigendum 1
- 2009 ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
- 2003 ISO 10993-1:2003 Biological evaluation of medical devices - Part 1: Evaluation and testing
- 1997 ISO 10993-1:1997 Biological evaluation of medical devices - Part 1: Evaluation and testing
- 1992 ISO 10993-1:1992/Cor 1:1992 Biological evaluation of medical devices; part 1: guidance on selection of tests; technical corrigendum 1
- 1992 ISO 10993-1:1992 Biological evaluation of medical devices; part 1: guidance on selection of tests
