Complied Standards - Veridian Healthcare 01-508 Serie Manual De Instrucciones

COMPLIED STANDARDS

Risk Management
ISO 14971:2007 Medical Devices — Application of risk management to medical devices
Labeling
EN 980:2008 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 Medical electrical equipment – Part 1: General requirements for basic safety
and essential performance
Electromagnetic compatibility
IEC 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
ANSI/AAMI SP10:2002/A2:2008 Manual, electronic, or automated sphygmomanometers
Software life-cycle processes
IEC 62304:2006+AC: 2008 Medical device software- Software life cycle processes
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