GB/T 16886.18-2011 Biological evaluation of medical devices—Part 18:Chemical characterization of materials

Scope

This part of GB/T 16886 describes the framework for material identification and the qualitative and quantitative analysis of their chemical composition. The chemical characterization information obtained can be used in several important applications, such as:
——As part of the overall biocompatibility evaluation of medical devices (ISO 10993-1 and ISO 14971).
——By measuring the leachable substance levels of medical devices to evaluate whether they comply with the allowable limits of the substance determined based on health risk assessment (ISO 10993-17).
——Determining the equivalence of proposed materials with clinically established materials.
——Determining the equivalence of final devices with prototype devices and checking the relevance of the prototype device data used to support the evaluation of final devices.
——Screening new materials suitable for the intended clinical applications of medical devices.
This part of GB/T 16886 does not involve the qualitative and quantitative analysis of degradation products. For this aspect, see ISO 10993-9, ISO 10993-13, ISO 10993-14, and ISO 10993-15.
The GB/T 16886 standard applies to materials or devices that come into direct or indirect contact with the human body. (See ISO 10993-1:2003, 4.2.1)
This part of GB/T 16886 is intended to be applied by material suppliers and medical device manufacturers during biocompatibility evaluations.

Development Information

Same series standard

Superseded by the following standards

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