This Document specifies requirements and gives guidance on the procedures in the preparation of samples and the selection of reference materials for medical device testing primarily in biological test systems primarily in accordance with one or more parts of the ISO 10993 series. Specifically, this document addresses the following.
Basic Data
Standard ID
GB/T 16886.12-2023 (GB/T16886.12-2023)
Description (Translated English)
Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
Sector / Industry
National Standard (Recommended)
Classification of Chinese Standard
C30
Classification of International Standard
11.100.20
Word Count Estimation
23,236
Date of Issue
2023-11-27
Date of Implementation
2024-12-01
Older Standard (superseded by this standard)
GB/T 16886.12-2017
Issuing agency(ies)
State Administration for Market Regulation, China National Standardization Administration
