BS EN ISO 10993-1:2020 PDF

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.

All current amendments available at time of purchase are included with the purchase of this document.

File Size :	1 file , 1.6 MB
ISBN(s) :	9780580948688
Note :	This product is unavailable in Ukraine, Russia, Belarus
Number of Pages :	50
Product Code(s) :	30344602, 30344602, 30344602
Published :	12/16/2020
Same As :	BS EN ISO 10993-1:2020