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Idiomas disponibles
Idiomas disponibles
-- Reorient or relocate the receiving antenna.
-- Increase the separation between the equipment
and receiver.
-- Connect the equipment into an outlet on a circuit
different from that to which the receiver is connected.
-- Consult the dealer or an experienced radio/TV
technician for help.
FCC Radiation Exposure Statement:
This equipment complies with FCC radiation exposure
limits set forth for an uncontrolled environment. This
transmitter must not be co-located or operating in
conjunction with any other antenna or transmitter.
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COMPLIED STANDARDS LIST
EN ISO 14971:2012 / ISO 14971:2007 Medical devices – Application
Risk Management
of risk management to medical devices
ISO 15223-1:2016 Medical devices. Symbols to be used with
Labeling
medical device labels, labelling and information to be supplied.
Part 1: General requirements
EN 1041:2008 Information supplied by the manufacturer of
User's Manual
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-
General
1-11:2015 Medical electrical equipment - Part 1-11: General
Requirements
requirements for basic safety and essential performance –
for Safety
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
Electromagnetic
equipment - Part 1-2: General requirements for basic safety and
Compatibility
essential performance - Collateral standard: Electromagnetic
compatibility – 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
Performance
sphygmomanometers – Part 3: Supplementary requirements for
Requirements
electro-mechanical blood pressure measuring systems IEC 80601-
2-30:2013 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
Clinical Investigation
automated non-invasive sphygmomanometers ISO 81060-2:2013
Non-invasive sphygmomanometers - Part 2: Clinical validation of
automated measurement type
EN 60601-1-6:2010/IEC 60601-1-6:2010+A1:2013 Medical electrical
equipment - Part 1-6: General requirements for basic safety
Usability
and essential performance - Collateral standard: Usability EN
62366:2008/ IEC 62366-1:2015 Medical devices - Application of
usability engineering to medical devices
Software Life-Cycle
EN 62304:2006/AC: 2008 / IEC 62304:2006 Medical device
Processes
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 –
Bio-Compatibility
Part 5: Tests for in vitro cytotoxicity ISO 10993-10:2010 Biological
evaluation of medical devices – Part 10: Tests for irritation and
skin sensitization
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