1 BY ONE TMB-1585-BS Manual Del Usuario página 19

COMPLIED STANDARDS LIST
EN ISO 14971:2012 / ISO 14971:2007 Medical devices
Risk management
EN
Application of risk management to medical devices
EN ISO 15223-1:2016 / ISO 15223-1:2016 Medical devices. Symbols to be used
Labeling with medical device labels, labelling and information to be supplied. Part 1:
DE
General requirements
EN 1041:2008+A1:2013 Information supplied by the manufacturer of medical
User manual
devices
FR
EN 60601-1:2006+A1:2013+A12:2014/ IEC 60601-1:2005+A1:2012 Medical
electrical equipment - Part 1: General requirements for basic safety and
ES General essential performance
Requirements for EN 60601-1-11:2015/ IEC 60601-1-11:2015 Medical electrical equipment -
Safety Part 1-11: General requirements for basic safety and essential performance -
Collateral standard: Requirements for medical electrical equipment and medical
IT
electrical systems used in the home healthcare environment
EN 60601-1-2:2015/ IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2:
Electromagnetic
General requirements for basic safety and essential performance - Collateral
compatibility
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:
Performance Supplementary requirements for electro-mechanical blood pressure measuring
requirements 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 automated non-invasive
Clinical
sphygmomanometers
investigation
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
Usability 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+A1:2015 Medical device software -
processes 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
Bio-compatibility
vitro cytotoxicity
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for
irritation and skin sensitization
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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.
Warning: Use of accessories, transducers and cables other than those speci ed or provided by the
manufacturer of this equipment could result in increased electromagnetic emissions or decreased
electromagnetic immunity of this equipment and result in improper operation."
Warning：Portable RF communications equipment (including peripherals such as antenna cables and
external antennas) should be used no closer than 30 cm (12 inches) to any part of the equipment ,
including cables speci ed by the manufacturer. Otherwise, degradation of the performance of this
equipment could result.
Technical description：
1，all necessary instructions for maintaining BASIC SAFETY and ESSENTIAL PERFORMANCE with regard
to electromagnetic disturbances for the excepted service life.
2，Guidance and manufacturer's declaration -electromagnetic emissions and Immunity
Table 1
Guidance and manufacturer's declaration - electromagnetic emissions
Emissions test
RF emissions
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
EMC GUIDANCE
Compliance
Group 1
Class B
Not applicable
Not applicable
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IT