GB/T 16886.9-2017 Replaced National standards

GB/T 16886.9-2017 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products

GB/T 16886.9-2017 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products

Publish Date: 2017-12-29 Implement Date: 2018-07-01 For services related to genuine standard inquiry, procurement, translation, and other related services in China, please Contact Us

Basic Information

Standard Code: GB/T 16886.9-2017

Standard Type: National standards

Standard Status: Replaced

is_force_gb: no

CCS Name: Medical devices

ICS Name: Medical equipment

Publish Date: 2017-12-29

Implement Date: 2018-07-01

Pages: 13 pages

Scope

This part of GB/T 16886 provides basic principles for the systematic evaluation of potential and observed biodegradation of medical devices, as well as the design and implementation of biodegradation studies. This part of GB/T 16886 does not apply to: a) the evaluation of degradation caused solely by mechanical processes; the methodology for generating such degradation products may be specified in specific product standards as appropriate.

Development Information

Word Count: 22 Thousand words Pages: 13 pages

Same series standard

GB/T 16886.5-2017 Biological evaluation of medical devices—Part 5:Tests for in vitro cytotoxicity GB/T 16886.10-2017 Biological evaluation of medical devices—Part 10:Tests for irritation and skin sensitization GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.13-2017 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices

Replace the following standards

GB/T 16886.9-2001 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products

Superseded by the following standards

GB/T 16886.9-2022 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products

Referenced Standards

ISO 10993-1 ISO 10993-2 ISO 10993-12 ISO 10993-13 ISO 10993-14 ISO 10993-15 ISO 10993-16 ISO 10993-17 ISO 10993-18 ISO/TS 10993-19

Adopt standards

ISO 10993-9:2009

Related Standards

GB 9706.8-1995 Replaced

GB 9706.8-1995 Medical electrical equipment—Part 2:Particular requirements for the safety of cardiac defibrillators and cardiac defibrillator-monitors

Publish Date: 1995-06-02

GB 11235-1997 Replaced

GB 11235-1997 VCu intra-uterine device

Publish Date: 1997-07-24

GB/T 17257.1-1998 Replaced

GB/T 17257.1-1998 Urine collection bags—Part 1:Vocabulary

Publish Date: 1998-03-18

GB/T 17257.2-1998 Replaced

GB/T 17257.2-1998 Urine collection bags—Part 2:Determination of dimensions

Publish Date: 1998-03-18

GB/T 17257.3-1998 Replaced

GB/T 17257.3-1998 Urine collection bags—Part 3:Verification of rated volume

Publish Date: 1998-03-18

GB/T 17257.4-1998 Replaced

GB/T 17257.4-1998 Urine collection bags—Part 4:Determination of freedom form leakage

Publish Date: 1998-03-18