B.O.L.T BT4 User Manual page 45

B.O.L.T User Manual
Systems; Harmonised Standard covering the essential requirements of article 3.1(b) of
Directive 2014/53/EU.
 EN 62304:2006/AC: 2008 Medical device software - Software life-cycle processes.

EN ISO 10993-1:2009/AC: 2010 Biological evaluation of medical devices- Part1:
Evaluation and Testing within a risk management process.
 EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in
vitro cytotoxicity.
 EN ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for
irritation and skin sensitization.
© Copyright 2019, All Rights Reserved. AmZetta Technologies Private Ltd.
2AFV6-AMI-BU-2
45