GB/T 16886.9-2001
Biological evaluation of medical devices-Part 9:Framework for identification and quantification of potential degradation product (English Version)

Standard No.

GB/T 16886.9-2001

Language

Chinese, Available in English version

Release Date

2001

Published By

General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China

Status

Be replaced 2018-07

Replace By

GB/T 16886.9-2017

Latest

GB/T 16886.9-2022

Scope

This part of GB/T 16886 provides general principles for the systematic evaluation of potential and observed biodegradation of medical devices, and provides general principles for the design and conduct of biodegradation studies. This part of GB/T 16886 does not apply to the following situations: A) engineered living tissue products; b) methodologies for evaluating or studying degradation products generated by mechanical processes. The method of generating such degradation products may be specified in specific product standards as the case may be; c) Leachable components of non-degradation products. When the qualitative and quantitative methods of degradation products applicable to a certain product are provided in the product standards, these standards take precedence over this part of GB/T 16886.

GB/T 16886.9-2001 history

• 2022 GB/T 16886.9-2022 Biological Evaluation of Medical Devices Part 9: Qualitative and Quantitative Framework for Potential Degradation Products
• 2017 GB/T 16886.9-2017 Biological evaluation of medical devices—Part 9: Framework for identification and quantification of potential degradation products
• 2001 GB/T 16886.9-2001 Biological evaluation of medical devices-Part 9:Framework for identification and quantification of potential degradation product

GB/T 16886.9-2001 -All Parts