Getinge Maquet PowerLED II User Manual

Introduction
Standards applied
1
Maquet PowerLED II
IFU 01811 EN 10
29 / 116
1.8 Standards applied
The device complies with the safety requirements of the following standards and directives:
Reference Title
IEC 60601-1:2005 + AMD1:2012
ANSI/AAMI ES60601-1:2005/(R)2012
CAN/CSA-C22.2 No. 60601-1:14
EN 60601-1:2006/A1:2013/A12:2014
Medical electrical equipment – Part 1: General re-
quirements for basic safety and essential perform-
ance
IEC 60601-2-41:2009+AMD1:2013
EN 60601-2-41:2009/A11:2011/A1:2015
Medical electrical equipment – Part 2-41: Particular
requirements for the safety of surgical luminaires and
luminaires for diagnosis
IEC 60601-1-2:2014
EN 60601-1-2:2015
Medical electrical equipment – Part 1-2: General re-
quirements for safety – Collateral standard: Electro-
magnetic disturbances – Requirements and tests
IEC 60601-1-2:2014+AMD1:2020
EN 60601-1-2:2015/A1:2021
Medical electrical equipment – Part 1-2: General re-
quirements for safety – Collateral standard: Electro-
magnetic disturbances – Requirements and tests
IEC 60601-1-6:2010+AMD1:2013
EN 60601-1-6:2010/A1:2015
Medical electrical equipment – Part 1-6: General re-
quirements for basic safety and essential perform-
ance – Collateral standard: Usability
IEC 60601-1-9:2007+AMD1:
2013+AMD2:2020
EN 60601-1-9:2008/A1:2014/A2:2020
Medical electrical equipment – Part 1-9: General re-
quirements for basic safety and essential perform-
ance – Collateral standard: Requirements for an en-
vironmentally friendly design
IEC 62366-1:2015
EN 62366-1:2015
IEC 62366-1:2015+AMD1:2020*
EN 62366-1:2015/A1:2020*
Medical devices – Part 1: Application of usability en-
gineering to medical devices
IEC 62304:2006+AMD1:2015
EN 62304:2006/A1:2015
Medical device software – Software life cycle pro-
cesses
ISO 20417:2020
EN ISO 20417:2021
Medical devices - Information provided by manufac-
turer
ISO 15223-1:2021
EN ISO 15223-1:2021
Medical devices - Symbols to be used with informa-
tion to be provided by manufacturer - Part 1: General
requirements
EN 62471:2008 Photobiological safety of lamps and lamp systems
IEC 62311:2019
EN 62311:2020
Assessment of electronic and electrical equipment re-
lated to human exposure restrictions for electromag-
netic fields (0 Hz – 300 GHz)
IEC 60825-1:2014
EN 60825-1:2014
Safety of laser products – Part 1: Equipment classific-
ation and requirements
Ordinance 384/2020 INMETRO Certification - Compliance assessment re-
quirements for equipment under Health Surveillance
Tab.4: Compliance with product standards
*only for pre-wired 4K configurations
Quality management:

Getinge Maquet PowerLED II Specifications

General

Brand	Getinge
Model	Maquet PowerLED II
Category	Medical Equipment
Language	English