GB/T 16886.12-2005
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:样品制备与参照样品
Application Summary AI generated
This standard specifies the procedures for preparing samples and selecting reference materials used in the biological evaluation of medical devices. It is applied by manufacturers and testing laboratories to ensure consistent and comparable test results when assessing the biocompatibility of materials that contact the human body, such as implants, surgical instruments, or wound dressings. The standard is critical for standardizing extraction methods and control materials in preclinical safety testing within the medical device industry.
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