Risk Management
ISO/EN 14971:2012 Medical devices
— Application of risk management to
medical devices
Labeling
ISO/EN 15223-1:2012 Medical devices.
Symbols to be used with medical device
labels, labeling and information to be
supplied. General requirements
User manual
EN 1041: 2008 Medical equipment
manufacturers to provide information
General
Requirements for
Safety
IEC 60601-1: 2005+A1:2012 Medical
electrical equipment - Part 1: General
requirements for basic safety and essential
performance
Electromagnetic
compatibility
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
Performance and
clinical requirements
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
Software life-cycle
processes
IEC/EN 62304:2006+AC: 2008 Medical
device software - Software life cycle
processes
Complied
Standards
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