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).
EN ISO 10993-1:2009 history
2020EN ISO 10993-1:2020 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10)
2009EN ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing
2003EN ISO 10993-1:2003 Biological evaluation of medical devices Part 1: Evaluation and testing ISO 10993-1:2003
1997EN ISO 10993-1:1997 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Supersedes EN 30993-1: 1994; ISO 10993-1 : 1997