GB/T 16886.9-2022
Biological Evaluation of Medical Devices Part 9: Qualitative and Quantitative Framework for Potential Degradation Products (English Version)

Standard No.: GB/T 16886.9-2022
Language: Chinese, Available in English version
Release Date: 2022
Published By: General Administration of Quality Supervision, Inspection and Quarantine of the People‘s Republic of China
Latest: GB/T 16886.9-2022
Replace: GB/T 16886.9-2017

Scope: This document specifies the basic principles for the systematic evaluation of potential and observed degradation of medical devices through the design and conduct of in vitro degradation studies. The information obtained from these studies can be used for the biological evaluation described in the GB/T(Z)16886 series of standards. This document applies to materials that are expected to degrade in vivo as well as materials that do not degrade. This document does not apply to: a) Evaluation of degradation produced by purely mechanical processes; see specific product standards (if any) for the methodology for producing such degradation products; Note: Purely mechanical degradation mainly produces particulate matter. Although not included in the scope of this document, such degradation products can cause biological reactions, and biological evaluation can be carried out according to the methods described in other parts of GB/T(Z)16886. b) leachable components that are not degradation products; c) medical devices or components that do not directly or indirectly contact patients.

GB/T 16886.9-2022 Referenced Document

ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-2 Biological evaluation of medical devices — Part 2: Animal welfare requirements

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