Full Description

This document specifies:

the general principles governing the biological evaluation of medical devices within a riskmanagement process;
the general categorization of medical devices based on the nature and duration of their contact withthe 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 medicaldevice;
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.

Product Details

Published:

12/16/2020

ISBN(s):

9780580948688

Number of Pages:

50

File Size:

1 file , 1.6 MB

Same As:

BS EN ISO 10993-1:2020

Product Code(s):

30344602, 30344602, 30344602

Note:

This product is restricted and cannot be purchased in the following countries Ukraine, Russia, Belarus