Certifications - American Megatrends B.O.L.T Chest ECG User Manual

B.O.L.T Chest ECG User Manual

15.0 Certifications

COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices.
This device complies with the following normative documents:
 EN 301489-1:V3.2.0:2017 ElectroMagnetic Compatibility (EMC) standard for radio
equipment and services; Part 17: Specific conditions for Broadband Data Transmission
Systems; Harmonised Standard covering the essential requirements of article 3.1(b) of
Directive 2014/53/EU
 EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Tests for in
vitro cytotoxicity
 EN ISO 10993-10:2010 Biological evaluation of medical devices -- Part 10: Tests for
irritation and skin sensitization
 EN 60601-1:2012 General requirements for basic safety and essential performance
 EN 60601-1-2-2007/AC: 2010 General requirements for safety -Collateral standard:
Electromagnetic compatibility.
 EN 60601-1-6:2010 Collateral standard: Usability
 IEC 60601-1-4:1996 General requirements for safety- Collateral standard:
Programmable electrical medical systems.
 IEC 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
 IEC 60601- 2-27:2011 Medical electrical equipment ─ Part 2-27: Particular
requirements for the basic safety and essential performance of electrocardiographic
monitoring equipment
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Model No: VA 07
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