ISO 10993-1:2003 PDF

Scope: This part of ISO 10993 describes a) the general principles governing the biological evaluation of medical devices; b) the categorization of devices based on the nature and duration of their contact with the body; c) the selection of appropriate tests. This part of ISO 10993 does not cover testing of materials and devices that do not come into direct or indirect contact with the patient's body, nor does it cover biological hazards arising from any mechanical failure. NOTE Other parts of ISO 10993 cover specific tests (see also the rationale in A.2).

ISO 10993-1:2003 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