Complied European Standards List - inventum BDP421 Instruction Manual

14

complied European standards list

Risk management
Labelling
User manual
General requirements for safety
Electromagnetic compatibility
Performance requirements
Clinical investigation
• English
46
EN ISO 14971: 2012 Medical devices - Application of risk management to medical devices
EN 980: 2008 Symbols for use in the labelling of medical devices
EN 1041: 2008 Information supplied by the manufacturer of medical devices
EN 60601-1: 2006+A1: 2013 Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance
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
EN 60601-1-2: 2007 Medical electrical equipment: Part 1-2: General requirements for basic
safety and essential performance - Collateral standard: Electromagnetic compatibility -
Requirement and tests
EN ISO 81060-1: 2012 Non-invasive sphygmomanometers - Part 1: Requirements and test
methods for non-automated measurement type
EN 1060-3: 1997+A2: 2009 Non-invasive blood pressure Part 3: Supplementary requirements
for electromechanical blood pressure measuring system
EN 1060-4: 2004 Non-invasive sphygmomanometers - Part 4: Test procedures to determine
the overall system accuracy of automated non-invasive sphygmomanometers