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

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Scope

This part of GB/T 16886 specifies that medical devices are tested in accordance with the biological systems specified in other parts of GB/T 16886.
The sample preparation and reference material selection requirements to be followed are given, and a program guide is given.
This section specifically proposes.
---Test sample selection;
--- Select a representative part from the device;
---Test sample preparation;
---Test control;
---Selection and requirements for reference materials;
--- Preparation of extract.
This section does not apply to living cells, but can be applied to materials or instrument components in a combination product containing living cells.

Basic Data

Standard ID	GB/T 16886.12-2017 (GB/T16886.12-2017)
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	22,289
Date of Issue	2017-12-29
Date of Implementation	2018-07-01
Older Standard (superseded by this standard)	GB/T 16886.12-2005
Regulation (derived from)	National Standards Bulletin 2017 No. 32
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine of the People's Republic of China, Standardization Administration of the People's Republic of China