This part of GB/T 16886 specifies the sample preparation and reference sample selection requirements to be followed when medical devices are tested in accordance with the biological system specified in other parts of GB/T 16886, and gives a step-by-step guide. This part specifies: - selection of test materials; - selection of representative parts from the device; - preparation of test samples; - test controls; - selection requirements for reference samples; and - preparation of extracts . The applicability of this section to absorbable materials, in situ polymerized materials, tissue engineered medical products and materials of biological origin should be carefully evaluated.
GB/T 16886.12-2005 history
2023GB/T 16886.12-2023 Biological Evaluation of Medical Devices Part 12: Sample Preparation and Reference Materials
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