GB/T 16886.6-2015: Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation

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Scope

This Part of GB/T 16886 specifies test methods for the assessment of the local effects
after implantation of biomaterials intended for use in medical devices.
This Part applies to materials that are.
- solid and non-biodegradable;
- degradable and/or resorbable;
- non-solid, such as porous materials, liquids, pastes and particulates.
The test specimen is implanted into a site and animal species appropriate for the
evaluation of the biological safety of the material. These implantation tests are not
intended to evaluate or determine the performance of the test specimen in terms of
mechanical or functional loading. This Part of GB/T 16886 may also be applied to
medical devices that are intended to be used topically in clinical indications where the
surface or lining may have been breached, in order to evaluate local tissue responses.
The local effects are evaluated by a comparison of the tissue response caused by a
test specimen to that caused by control materials used in medical devices of which the
clinical acceptability and biocompatibility characteristics have been established. The
objective of the test methods is to characterize the history and evolution of the tissue
response after implantation of a medical device/biomaterial including final integration
or resorption/degradation of the material. In particular for degradable/resorbable
materials the degradation characteristics of the material and the resulting tissue
response should be determined.
This Part does not deal with systemic toxicity, carcinogenicity, teratogenicity or
mutagenicity. However, the long-term implantation studies intended for evaluation of
local biological effects may provide insight into some of these properties. Systemic
toxicity studies conducted by implantation may satisfy the requirements of this Part of
GB/T 16886.

Basic Data

Standard ID	GB/T 16886.6-2015 (GB/T16886.6-2015)
Description (Translated English)	Biological evaluation of medical devices -- Part 6: Tests for local effects after implantation
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.040.01
Word Count Estimation	23,216
Date of Issue	2015-12-10
Date of Implementation	2017-04-01
Older Standard (superseded by this standard)	GB/T 16886.6-1997
Regulation (derived from)	National Standard Announcement 2015 No.38
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