This Part of GB/T 16886 specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical devices testing in biological systems in accordance with one or more parts of the GB/T 16886 series. Specifically, this Part addresses. — test material selection; — selection of representative portions from a device; — test sample preparation; — experimental controls; — selection of and requirements for reference materials; and — preparation of extracts. The applicability of this Part to absorbable materials, materials that polymerize in situ, tissue-engineered medical products and materials of biological origin should be carefully evaluated.
Basic Data
Standard ID
GB/T 16886.12-2005 (GB/T16886.12-2005)
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
11.110
Word Count Estimation
15,141
Date of Issue
2005-03-23
Date of Implementation
2005-12-01
Older Standard (superseded by this standard)
GB/T 16886.12-2000
Quoted Standard
GB/T 16886.1; YY/T 0316
Adopted Standard
ISO 10993-12-2002; IDT
Regulation (derived from)
Announcement of Newly Approved National Standards No. 6, 2005 (No. 80 overall)
Issuing agency(ies)
General Administration of Quality Supervision, Inspection and Quarantine of the People Republic of China, China National Standardization Administration Committee
Summary
This standard specifies: medical equipment in accordance with GB/T 16886 other parts of the regulations biological systems when tested, to be followed Sample preparation and reference samples Select requirements, and gives a step by step guide.
