User's Manual

Rev.1.0 Page 135 of 151 VW40-152-009
VIVIX-S 1012N User Manual
U.S.A / Canada
Item
IEC 60601
-1(ed.2 am1+ am2+ co1)
Medical electrical equipment
- Part1: General requirements for safety
UL 60601
-1(ed.2)
-
CSA
-C22.2 No. 601-1-M90 (R2006)
Medical electrical equipment
– Part 1: General
requirements for safety
(adopted amendment 2:1995
to IEC60601-1)
IEC 60601
-1-2: 2007 (ed.3)
Medical electrical equipment
-Part 1-2: Collateral standard:
Electromagnetic compatibility
IEC 60601
-1-4: 2000 (ed.1.1)
Medical electrical equipment
- Part 1-4: Collateral Standard:
Programmable electrical medical systems
IEC 62304:2006
Medical device software
-software life cycle processes
ISO 14971:2012
Medical Device
- Application of risk management to medical devices
European Union
Item
MDD
(Medical Device Directive)
93/42/EEC
as amended by 2007/47/EC
EN ISO 13485:
2012
Medical devices
– Quality Management systems – Requirements for
regulatory purposes
EN 60601
-1: 2007(ed.3)
Medical electrical equipment
- Part1: General requirements for safety
IEC 60601
-1-2: 2007(ed.3)
Medical electrical equipment
-Part 1-2: Collateral Standard :
Electromagnetic compatibility
-Requirements and tests
IEC 60601
-1-4: 2000(ed.1.1)
Medical electrical equipment
- Part 1-4: Collateral Standard :
Programmable electrical medical systems
IEC 62304:2006
Medical device software
-Software life cycle processes
ISO 14971: 2012
Medical device
– Application of risk management to medical devices.