Complied Standards - smartheart 01-509 Manual De Instrucciones

COMPLIED STANDARDS LIST
Risk management
Labeling
User manual
General
Requirements
for Safety
Electromagnetic
compatibility
Performance
requirements
Clinical
investigation
Usability
Software life-cycle
processes
Bio-compatibility
Adaptor
EN ISO 14971:2012 / ISO 14971:2007 Medical devices
Application of risk management to medical devices
EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices. Symbols to be used with medical device labels,
labelling and information to be supplied. Part 1: General requirements
EN 1041:2013 +A1:2013 Information supplied by the manufacturer of medical devices
EN 60601-1:2006+A1:2013/ IEC 60601-1:2005+A1:2012 Medical electrical equipment - Part 1: General
requirements for basic safety and essential performance
EN 60601-1-11:2015/ IEC 60601-1-11:2015 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 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic
safety and essential performance - Collateral standard: Electromagnetic disturbances - Requirements 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 sphygmomanometers - Part 3: Supplementary requirements for electro-
mechanical blood pressure measuring systems
IEC 80601-2-30:2009+A1:2013 Medical electrical equipment- Part 2-30: Particular requirements for the basic
safety and essential performance of automated non-invasive sphygmomanometers
EN 1060-4:2004 Non-invasive sphygmomanometers - Part 4: Test procedures to determine the overall system
accuracy of automated non-invasive sphygmomanometers
ISO 81060-2:2013 Non-invasive sphygmomanometers - Part 2: Clinical validation of automated measurement type
EN 60601-1-6:2010+A1:2015/IEC 60601-1-6:2010+A1:2013 Medical electrical equipment - Part 1-6: General
requirements for basic safety and essential performance - Collateral standard: Usability
IEC 62366-1:2015 Medical devices - Part 1: Application of usability engineering to medical devices
EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015
Medical device software - Software life-cycle processes
ISO 10993-1:2009 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk
management process
ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
Type: BLJ06L060100P-U
Input: 100-240V, 50-60Hz, 0.2Amax Output: 6V 10000mA
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