GB/T 16886.3-2008: Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity

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Scope

This part of GB/T 16886 specifies the following biology medical device hazard identification strategies and tests.
- Genotoxicity,
--- carcinogenicity, and
Reproductive and developmental toxicity.
This part of GB/T 16886 is suitable for the evaluation of medical devices that are considered to have potential genetic toxicity, carcinogenicity or reproductive toxicity.
Note. A guide to test selection is given in GB/T 16886.1/ISO 10993-1.

Basic Data

Standard ID	GB/T 16886.3-2008 (GB/T16886.3-2008)
Description (Translated English)	Biological evaluation of medical devices -- Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.100
Word Count Estimation	18,169
Date of Issue	2008-01-22
Date of Implementation	2008-09-01
Older Standard (superseded by this standard)	GB/T 16886.3-1997
Quoted Standard	GB/T 16886.1; GB/T 16886.2; GB/T 16886.6; GB/T 16886.12; ISO 10993-18; OECD 414; OECD 415; OECD 416; OECD 421; OECD 451; OECD 453; OECD 471; OECD 473; OECD 476
Adopted Standard	ISO 10993-3-2003, IDT
Regulation (derived from)	National Standard Approval Announcement 2008 No.2 (Total No.115)
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
Summary	This standard specifies the following aspects of the medical device biological hazard identification and testing strategies: genotoxicity, carcinogenicity, reproductive and developmental toxicity. GB/T 16886 apply to this part of the evaluation were identified as having the potential genotoxicity, carcinogens or reproductive toxicity of medical devices.