GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process

Scope

This part of GB/T 16886 describes:
——The basic principles guiding the biological evaluation of medical devices within the risk management framework for medical devices;
——A general classification of medical devices according to the nature and duration of their contact with the human body;
——The evaluation of relevant data from all sources;
——The identification of defects in the available data sets based on risk analysis;
——The identification of other data sets required for the biological safety analysis of medical devices;
——The evaluation of the biological safety of medical devices.
This part does not include tests on materials and devices that do not directly or indirectly come into contact with patients' bodies, nor does it include biological hazards caused by mechanical failures. The specific tests included in other parts of GB/T 16886 are given in the preface.

Development Information

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