SS-EN ISO 10993-1:2009现行
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2009)
出版：Standardiserings-Kommissionen I Sverige
专家解读视频
This part of ISO 10993 describes:? - the general principles governing the biological evaluation of medical devices within a risk management process;? - the general categorization of 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.
EN ISO 10993-1 : 2009 - Identical
ISO 10993-1 : 2009 - Identical
ISO 10993-1 : 2009 - Identical
