Greater Goods Balance 0600, Operation Manual

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Risk management
Labeling
User manual
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
General
Requirements
For Safety
Electromagnetic
compatibility