Itamar Medical Ltd.
Endo
PAT
TM
x Device
5
Operation Manual
STANDARD
#
2.
Medical electrical equipment – Part 1-2: General requirements
for basic safety and essential performance - Collateral
standard: Electromagnetic compatibility - Requirements and
tests
EN 60601-1-2:2015
[the product was
developed according to:
IEC 60601-1-2: 2014
(Ed.4)]
3.
Medical Device Software – Software Life Cycle Processes
EN 62304:2006
[the product was
developed according to:
IEC 62304: 2006 +
AMD1:2015]
4.
Biological evaluation of medical devices – Part 1: Evaluation
and testing within a risk management process
EN ISO 10993-1: 2009
5.
Medical devices. Quality management systems. Requirements
for regulatory purposes
EN ISO 13485:2016
6.
Medical devices. Application of risk management to medical
devices
EN ISO 14971: 2012
7.
Medical devices. Symbols to be used with medical device
labels, labelling and information to be supplied. General
requirements
EN ISO 15223-1:2016
[the product was
developed according to:
ISO 15223-1: 2016]
8.
Graphical symbols for electrical equipment in medical
practice
IEC/TR 60878: 2015
9.
Graphical symbols -- Safety colours and safety signs --
Registered safety signs; refer to instruction manual/ booklet
ISO 7010:2019 -M002
10.
Information supplied by the manufacture with medical devices EN 1041: 2008 +
A1:2013
11.
Medical Device Directive
MDD 93/42 EEC:1993
MDD 2007/47/EC:2007
12.
FDA Quality Systems Regulation (QSR)
21 CFR part 820
