GB/T 16886.12-2017
AbolishedBiological evaluation of medical devices—Part 12:Sample preparation and reference materials
医疗器械生物学评价 第12部分：样品制备与参照材料
Application Summary AI generated
This standard specifies methods for preparing samples and selecting reference materials used in biological evaluation tests of medical devices. It is applied in the medical device industry to ensure consistent and reproducible testing conditions for assessing biocompatibility, such as cytotoxicity, sensitization, or implantation studies. The standard guides manufacturers and testing laboratories in proper sample handling, extraction procedures, and control material selection to meet regulatory requirements.
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Transparency note: The application summary and key sentences on this page were automatically generated by AI from the standard's original text. This content has not been human-verified and should not be used for compliance or regulatory purposes. Always refer to the official standard document from the issuing authority.