Reference to Standards
This device complies with the following normative documents:
COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices as amended by
Directive 2007/47/EC
• EN ISO 13485:2003 /AC: 2009:Medical devices - Quality management systems – Requirements
for regulatory purposes (ISO 13485:2003) Reference to standards contd.
• EN ISO14971:2012: Medical devices - Application of risk management to medical devices (ISO
14971:2007, Corrected version 2007-10-01)
• IEC60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007); EN 60601-1:2006+AC (2010) : Medical
electrical equipment - Part 1:General requirements for basic safety and essential Performance
• EN1060-3:1997+A1:2005+A2:2009: Non-invasive sphygmomanometers, Part 3: Supplementary
requirements for electromechanical blood pressure measuring systems
• EN1060-4: 2004 Non-invasive sphygmomanometers. Test procedures to determine the overall
system accuracy of automated non-invasive sphygmomanometers.
• IEC/EN 60601-1-11 : 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 80601-2-30: 2009 (First Edition) for use in conjunction with IEC 60601-1:2005
• EN 80601-2-30: 2010/ ANSI/AAMI 80601-2-30: 2009 : Particular requirements for the basic
safety and essential performance of automated non-invasive sphygmomanometers
• EN60601-1-2: 2007 /AC 2010: Medical electrical equipment: Part 1‐2: General requirements for
basic safety and essential performance-collateral standard electromagnetic compatibility
• EN 55011Group 1 Class B: 2009+A1:2010 : Industrial, scientific and medical equipment - Radio-
frequency disturbance characteristics - Limits and methods of measurement
• FCC 47CFR PART 15B AND ANSI C63.4 (2003)
• EN ISO 10993-1:2009 Biological evaluation of medical devices-Part 1: Evaluation and testing
within a risk management process (ISO 10993-1:2009)
• ANSI/AAMI SP10: 2002/A1 2003(R) 2008: Manual, electronic or automated
sphygmomanometers
• ANSI/AAMI/ISO 81060-1:2007,ANSI/AAMI/IEC 80601-2-30:2009, ANSI/AAMI/ISO 81060‐2:2009
Non‐invasive sphygmomanometers Part 2: Clinical validation of automated measurement type
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