GB/T 16886.1-2011
AbolishedBiological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
医疗器械生物学评价 第1部分：风险管理过程中的评价与试验
Application Summary AI generated
GB/T 16886.1-2011 specifies the framework for evaluating the biological safety of medical devices within a risk management process. It is applied by manufacturers and testing laboratories to select appropriate biological tests (e.g., cytotoxicity, sensitization) based on the device's intended use, material composition, and duration of patient contact. This standard is critical for ensuring that medical devices, such as implants, surgical instruments, or diagnostic equipment, meet safety requirements before market approval in China.
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