GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials

Scope

This part of GB/T 16886 specifies the requirements for sample preparation and reference material selection when medical devices are tested according to the biological systems stipulated in other parts of GB/T 16886, and provides procedural guidelines. This part specifically proposes: -- selection of test samples; -- selection of representative parts from the device; -- preparation of test samples; -- preparation of test controls; -- selection and requirements of reference materials; -- preparation of extracts. This part is not applicable to living cells, but it can be applied to materials or device components in combination products containing living cells.

Development Information

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Superseded by the following standards

Referenced Standards

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