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

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Scope

This part of GB/T 16886 is a systematic review of the potential and observed biodegradation and biodegradation studies of medical devices.
The basic principles are provided by the calculation and implementation.
This part of GB/T 16886 does not apply to.
a) evaluation of degradation caused solely by mechanical processes; methodologies for generating such degradation products may be subject to specific product standards
Provision
Note 1. Pure mechanical degradation mainly produces particulate debris. Although not within the scope of this part of GB/T 16886, this degradation product can be cited
Biological reactions are required, so biological evaluations are required in accordance with the requirements of other parts of GB/T 16886.
b) leaching components resulting from non-degradation;
c) Medical devices or components that do not directly or indirectly contact the patient's body.
Note 2. This part of GB/T 16886 applies to the degradation of materials used in any product defined in GB/T 16886.1 “Medical Devices”, even if such
The product is different from the applicable regulations for medical devices. Such as a stent for tissue engineering medical products, or a carrier for releasing a drug or biological agent.

Basic Data

Standard ID	GB/T 16886.9-2017 (GB/T16886.9-2017)
Description (Translated English)	Biological evaluation of medical devices -- Part 9: Framework for identification and quantification of potential degradation products
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.100.20
Word Count Estimation	14,152
Date of Issue	2017-12-29
Date of Implementation	2018-07-01
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