Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process

2Scope / Description

This document defines:
　——General principles for the biological assessment of medical devices during risk management;
　——A general classification of medical devices based on the nature and duration of contact with the body;
　——An assessment of existing relevant data from all sources;
　——Identification of gaps in available datasets based on risk analysis;
　——Identification of additional datasets required for analyzing the biological safety of medical devices;
　——Assessment of the biological safety of medical devices. This document applies to the assessment of medical devices made of materials intended for direct or indirect contact with:
　——the patient's body for the intended use;
　——the user's body if the medical device is used for protection (e.g., surgical gloves, masks, etc.). This document applies to the biological assessment of all types of medical devices, including active, passive, implantable, and non-implantable medical devices. This document also provides guidance on assessing biological hazards from:
　——risks such as those of the medical device that change over time, as part of an overall biological safety assessment;
　——the rupture of the medical device or a component thereof, resulting in tissue exposure to new or novel materials. This document excludes hazards associated with bacteria, molds, yeasts, viruses, infectious spongiform encephalopathy (TSE) agents, and other pathogens.