CalHealth md-100 User Manual - Reference to Standards
MDMouse User Manual Model MD-100
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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 reg-
ulatory 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 re-
quirements 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 - Ra-
dio-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