RS ISO 10993-1: 2018
Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process


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

General Information

RS ISO 10993-1: 2018ADOPTED AFSEC STANDARDSHealth care technology49Fifth EditionAvailable
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