This standard specifies the requirements for sample preparation of medical devices in accordance with the biological system tests specified in other parts of GB/T 16886, and provides guidance for the steps to be followed. Including: a) selection of test materials; b) selection of a representative part from the device; c) preparation of test samples; d) selection of references to demonstrate the suitability of the test system and/or to allow relative comparison of the biological activity of the test samples Sample; e) Extraction solution preparation.
GB/T 16886.12-2000 history
2017GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials
2005GB/T 16886.12-2005 Biological evaluation of medical devices-Part 12:Sample preparation and reference materials
2000GB/T 16886.12-2000 Biological evaluation of medical devices--Part 12: Sample preparation and reference materials