GB/T 16886.13-2001
Biological evaluation of medical devices--Part 13:Identification and quantification of degradation products from polymeric medical devices (English Version)

Standard No.: GB/T 16886.13-2001
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 16886.13-2017
Latest: GB/T 16886.13-2017

Scope: This part of GB/T 16886 provides guidance on the design of qualitative and quantitative tests for degradation products of finished polymeric medical devices intended for clinical use. This part of GB/T 16886 describes two test methods for the formation of degradation products, one is the accelerated degradation test as a screening method, and the other is the actual time degradation test. For materials that polymerize upon use, the cured polymer is used in the test. The data obtained from the experiment were used for the biological evaluation of the polymer. This part of GB/T 16886 only deals with the degradation products of finished polymer devices due to chemical changes, and does not involve the degradation of polymer devices caused by mechanical stress, friction or electromagnetic radiation. This part of GB/T16886 does not involve the biological activity of fragments and soluble degradation products, and it is recommended to evaluate it according to the principles in GB/T16886.1 and ISO10993-17. Due to the wide range of polymeric materials used in medical devices, no specific analytical technique is specified or specified. This part of GB/T 16886 does not specify specific requirements for acceptable levels of degradation products.

GB/T 16886.13-2001 history

2017 GB/T 16886.13-2017 Biological evaluation of medical devices—Part 13: Identification and quantification of degradation products from polymeric medical devices
2001 GB/T 16886.13-2001 Biological evaluation of medical devices--Part 13:Identification and quantification of degradation products from polymeric medical devices