GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process

Scope

This document stipulates:
——The basic principles guiding the biological evaluation of medical devices in the risk management process;
——The basic classification of medical devices according to the nature and duration of their contact with the human body;
——The evaluation of existing relevant data from all sources;
——The identification of defects in 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 document applies to the evaluation of materials and medical devices that are expected to come into direct or indirect contact with the following:
——The patient's body during the intended use;
——The user's body, if the medical device is used for protective purposes (such as surgical gloves, masks, etc.).
This document applies to the biological evaluation of various types of medical devices, including active, passive, implantable, and non-implantable medical devices.
This document also provides guidelines for the evaluation of biological hazards (sources) caused by the following:
——The risks caused by the change of medical devices over time as part of the comprehensive biological safety evaluation;
——The damage to medical devices or their components resulting in human tissue exposure to new or innovative materials.
Other parts of GB/T 16886 contain specific content on biological evaluation and related tests. Mechanical performance tests are given in specific standards or product standards for medical devices.
This document does not apply to hazards (sources) related to bacteria, fungi, yeast, viruses, transmissible spongiform encephalopathy (TSE) factors, and other pathogens.

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