GB/T 16886.13-2017: Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices

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Scope

This part of GB/T 16886 is a qualitative and quantitative test for the degradation products of the simulated polymer medical device simulation environment prepared for clinical use.
The design provides general requirements.
This section describes two test methods for the formation of degradation products, one for accelerated degradation testing as a screening method and the other for simulation.
Real-time degradation testing of the environment. For materials that are polymerized in situ during use, the cured polymer is used in the test. Test data were used
Biological evaluation of polymers. This section applies only to non-absorbent polymers, and similar but suitably adjusted test procedures may also apply.
For absorbable polymers.
This section only applies to degradation products produced by chemical changes in finished polymer devices, not applicable to the intended use of the device.
Mechanical stress, wear, electromagnetic radiation or degradation of the device caused by biological factors such as enzymes, other proteins and cellular activities.
Note. This section presents an informative text discussing polymer environmental stress cracking (ESC), which is helpful for degradation research design (see Appendix B).
This section does not cover the biological activity of debris and soluble degradation products, which should be in accordance with GB/T 16886.1, GB/T 16886.16 and
The principle of GB/T 16886.17 was evaluated.
Due to the wide range of polymeric materials used in medical devices, no specific analytical techniques have been specified or specified. This section is not degraded
The acceptable level of product specifies specific requirements.

Basic Data

Standard ID	GB/T 16886.13-2017 (GB/T16886.13-2017)
Description (Translated English)	Biological evaluation of medical devices -- Part 13: Identification and quantification of degradation products from polymeric medical devices
Sector / Industry	National Standard (Recommended)
Classification of Chinese Standard	C30
Classification of International Standard	11.100.20
Word Count Estimation	18,123
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