1
Introduction
Standards applied
24 / 106
VOLISTA
IFU 01781 EN 19
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 per-
formance
IEC 60601-2-41:2009+AMD1:2013
EN 60601-2-41:2009/A11:2011/A1:2015
Medical electrical equipment – Part 2-41: Particu-
lar requirements for the safety of surgical lumin-
aires and luminaires for diagnosis
IEC 60601-1-2:2014
EN 60601-1-2:2015
Medical electrical equipment – Part 1-2: General
requirements for safety – Collateral standard:
Electromagnetic disturbances – Requirements
and tests
IEC
60601-1-6:2010+AMD1:2013+AMD2:2020
EN 60601-1-6:2010/A1:2015/A2:2021
Medical electrical equipment – Part 1-6: General
requirements for basic safety and essential per-
formance – 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
requirements for basic safety and essential per-
formance – Collateral standard: Requirements for
an environmentally friendly design
IEC 62366-1:2015+AMD1:2020
EN 62366-1:2015/A1:2020
Medical devices – Part 1: Application of usability
engineering 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 manu-
facturer
ISO 15223-1:2021
EN ISO 15223-1:2021
Medical devices - Symbols to be used with in-
formation to be provided by manufacturer - Part
1: General requirements
EN 62471:2008 Photobiological safety of lamps and lamp sys-
tems
IEC 62311:2019
EN 62311:2020
Assessment of electronic and electrical equip-
ment related to human exposure restrictions for
electromagnetic fields (0 Hz – 300 GHz)
Ordinance 384/2020 INMETRO Certification - Compliance assessment
requirements for equipment under Health Surveil-
lance
Tab.3: Compliance with product standards
To Next Page
Loading...
