This part of ISO 10993 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological systems in accordance with one or more parts of ISO 10993. Specifically@ this part of ISO 10993 addresses the following: -test sample selection; -selection of representative portions from a device; -test sample preparation; -experimental controls; -selection of@ and requirements@ for reference materials; - preparation of extracts. This part of ISO 10993 is not applicable to live cells@ but can be relevant to the material or device components of combination products containing live cells.
EN ISO 10993-12:2012 history
2021EN ISO 10993-12:2021 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials (ISO 10993-12:2021)
2012EN ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
2009EN ISO 10993-12:2009 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
2007EN ISO 10993-12:2007 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
2004EN ISO 10993-12:2004 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials
1996EN ISO 10993-12:1996 Biological Evaluation of Medical Devices - Part 12: Sample Preparation and Reference Materials ISO 10993-12 : 1996