7
ANSI/AAMI ST55:2016 Tabletop steam sterilizers
IEC 61010-1 3.1 Edition, January 2017 Safety Requirements for electrical
equipment for measurement control and laboratory use.
EN 61010-2-40: 2015 Safety requirements for sterilizers and washer-
disinfectors used to treat medical materials.
EN ISO 15223-1: 2016 Symbols for use in the labeling of medical devices.
EN 1041: 2008 + A1:2014 Information to be supplied by the manufacturer
of medical devices
EN 60529:1992 + A2:2013 Degrees of protection provided by enclosures
(IP Code)
EN 61326-1: 2013 for EMC Requirements for Electrical Equipment.
IEC 62304:2014 + A1: 2015
– Medical Device Software – Software life
cycle processes.
EN 62304:2006/AC:2008
– Medical Device Software – Software life cycle
processes.
IEC 62366-1: 2015
– Part1: Application of Usability Engineering to Medical
Devices
EN 62366:2008 - Application of Usability Engineering to Medical Devices
ANSI/AAMI ST55:2016
1.2.1
And in consideration with:
FDA QSR 21 CFR part 820 & part 11
