ISO 10993-1:2018 | 合法醫療器材資訊網

ISO10993-1:2018.Biologicalevaluationofmedicaldevices—Part1:Evaluationandtestingwithinariskmanagementprocess ...

This document specifies:

— the general principles governing the biological evaluation of medical devices within a risk management process;

— the general categorization of medical devices based on the nature and duration of their contact with the body;

— the evaluation of existing relevant data from all sources;

— the identification of gaps in the available data set on the basis of a risk analysis;

— the identification of additional data sets necessary to analyse the biological safety of the medical device;

— the assessment of the biological safety of the medical device.

This document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with:

— the patients body during intended use;

— the users body, if the medical device is intended for pr...