eta Compact 2297 90000, Инструкция по эксплуатации

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Complied Standards List
Risk management EN ISO 14971:2012 / ISO 14971:2007 Medical devices - Application of risk
management to medical devices
Labeling 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
User manual EN 1041:2008 +A1:2013 Information supplied by the manufacturer of
medical devices
General
Requirements
for Safety
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
Electromagnetic
compatibility
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
Performance
requirements
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
Clinical investigation 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
Usability 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
Software life-cycle
processes
EN 62304:2006/AC: 2008 / IEC 62304: 2006+A1:2015 Medical device
software - Software life-cycle processes
Bio-compatibility 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
EMC GUIDANCE
The ME EQUIPMENT or ME SYSTEM is suitable for home healthcare environments
Warning
: Don’t near active HF surgical equipment and the RF shielded room of an ME
system for magnetic resonance imaging, where the intensity of EM disturbances is high.
Warning
: Use of this equipment adjacent to or stacked with other equipment should
be avoided because it could result in improper operation. If such use is necessary, this
equipment and the other equipment should be observed to verify that they are operating
normally.
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