GB/T 16886.5-2003: Biological evaluation of medical devices -- Part 5: Test for in vitro cytotoxicity

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Scope

This part of GB/T 16886 describes test methods to assess the in vitro cytotoxicity of
medical devices.
These methods specify the incubation of cultured cells either directly or through diffusion.
a) with extracts of a device, and/or
b) in contact with a device.
These methods are designed to determine the biological response of mammalian cells in
vitro using appropriate biological parameters.

Basic Data

Standard ID	GB/T 16886.5-2003 (GB/T16886.5-2003)
Description (Translated English)	Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.040.01
Word Count Estimation	11,150
Date of Issue	2003-03-05
Date of Implementation	2003-08-01
Older Standard (superseded by this standard)	GB/T 16886.5-1997
Quoted Standard	GB/T 16886.1; GB/T 16886.12-2000
Adopted Standard	ISO 10993-5-1999; IDT
Issuing agency(ies)	General Administration of Quality Supervision, Inspection and Quarantine of the People Republic of China
Summary	This standard specifies: in vitro cytotoxicity evaluation of medical devices Test method. The method provides for the following test directly or by diffusion way contact and cultured cells were incubated: a, using instruments extracts, and/or, b, contact with the instrument. These methods are used accordingly biological parameters measured in mammalian cells in vitro biological reactions.