GB/T 16886.12-2023 Active National standards

GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials

Publish Date: 2023-11-27 Implement Date: 2024-12-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

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Basic Information

Standard Code: GB/T 16886.12-2023

Standard Type: National standards

Standard Status: Active

is_force_gb: no

CCS Name: Medical devices

ICS Name: -

Publish Date: 2023-11-27

Implement Date: 2024-12-01

Pages: 24 pages

Scope

This document specifies the requirements for sample preparation and reference material selection when testing medical devices in biological systems primarily in accordance with one or more sections of ISO 10993 (all parts), and provides procedural guidance. This document applies to: -- selection of test samples; -- selection of representative parts of medical devices; -- preparation of test samples; -- test controls; -- selection and requirements of reference materials; -- preparation of extracts. This document does not apply to living cells, but it can be applied to materials or components of combination products containing living cells. Extraction for chemical characterization is covered in ISO 1099318. Chapters 7, 8, 9, and 10 (except for 10.3.5 and 10.3.11 b)) and Chapter 11 of this document apply to extraction for chemical characterization, and the information given in Appendix C, C.1 to C.4, may also be relevant.