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Risk management
Labeling
User manual
General Requirements for
Safety
Electromagnetic
compatibility
Performance
requirements and Clinical
Investigation
Software life-cycle
processes
ISO/EN 14971:2012 Medical devices — Application of risk
management to medical devices
ISO/EN 15223-1:2012 Medical devices. Symbols to
be used with medical device labels, labelling and
information to be supplied. General requirements
EN 1041: 2008 Medical equipment manufacturers to
provide information
IEC 60601-1: 2005+A1; 2012 Medical electrical
equipment - Part 1: General requirements for basic
safety and essential performance
IEC/EN 60601-1-2:2007 Medical electrical
equipment - Part 1-2: General requirements
for basic safety and essential performance -
Collateral standard:Electromagnetic compatibility
- Requirements and tests
IEC 80601-2-30:2009 Medical electrical
equipment- Part 2-30: Particular requirements
for the basic safety and essential performance of
automated non-invasive sphygmomanometers
ANSI/AAMI SP10:2002/A2: 2008 Manual, electronic, or
automated sphygmomanometers
IEC/EN 62304:2006+AC: 2008 Medical device
software - Software life cycle processes
AUTHORIZED COMPONENT
Use the Vive® authorized adaptor. (Not Included)
Adaptor
Type: UE08WCP-060100SPA
Input: 100~240V, 50~60Hz,400mA
Output: 6V 1A
(Conforms to UL certificate)
COMPILED STANDARDS LIST
FCC STATEMENT
This device complies with Part 15 of the FCC Rules. Operation is subject to the
following two conditions: (1) this device may not cause harmful interference,
and (2) this device must accept any interference received, including
interference that may cause undesired operation.
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