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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, labelling and information to be supplied. General requirements
User manual
EN 1041: 2008 Medical equipment manufacturers to provide information
General Requirements
for Safety
EN 60601-1: 2006 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
IEC/EN 60601-1-11: 2010 Medical electrical equipment -- Part 1-11: General requirements for basic safety and essential performance - Collateral standard:
Requirements for medical electrical equipment and medical electrical systems used in
the home healthcare environment
IEC/EN 80601-2-30:2009 Medical electrical equipment - Part 2-30: Particular requirements for the basic safety and essential performance of automated
noninvasive sphygmomanometers
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
requirements
EN 1060-1:1995+A2:2009 Non-invasive blood pressure
Part 1: General requirements
EN 1060-3:1997+A2:2009 Non-invasive blood pressure Part 3: Supplementary requirements for electromechanical blood pressure measuring system
Clinical investigation
EN 1060-4: 2004 Automatic Blood Pressure Monitor overall system Interventional accuracy of the testing process
Usability
IEC/EN 60601-1-6: 2010 Medical electrical equipment -- Part 1-6: General requirements for basic safety and essential performance - Collateral Standard:
Usability
IEC/EN 62366: 2007 Medical devices - Application of usability engineering to medical devices
Software life-cycle
processes
IEC/EN 62304:2006+AC: 2008 Medical device software
- Software life cycle processes
Complied European Standards List
EMC Guidance
1. The Blood Pressure Monitor needs special precautions regarding EMC and needs to be installed and put into service
according to the EMC information provided in the ACCOMPANYING DOCUMENTS
2. Wireless communications equipment such as wireless home network devices, mobile phones, cordless telephones and their base
stations, walkie-talkies can affect this equipment and should be kept at least a distance d = 3,3 m away from the equipment.
(Note. As indicated in Table 6 of IEC 60601-1-2:2007 for ME EQUIPMENT, a typical cell phone with a maximum output power of 2
W yields d = 3,3 m at an IMMUNITY LEVEL of 3 V/m)