GB/T 16886.12-2023 regulates sample preparation and reference materials in the biological evaluation of medical apparatus. It details the preparatory process of collection, pretreatment, extraction and other medical apparatus samples to ensure that the samples can truly reflect the characteristics of the product. For different types of medical apparatus, such as implants and contacts, specific preparatory methods are given. At the same time, the selection and use of reference materials are clarified to ensure the accuracy of the evaluation as a comparison benchmark. Through this standard, samples and reference materials that meet the requirements can be obtained, providing a reliable basis for the biological safety evaluation of medical apparatus, helping to ensure the safety of patients and promote the healthy development of the medical apparatus industry.
| Status | Active |
|---|---|
| CCS | C 30 | ICS | 11.100.20 |
| Release Date | 2023-11-27 00:00:00 | Implementation Date | 2024-12-01 00:00:00 |