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REFERENCE TO STANDARDS
* COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices as amended by Directive 2007/47/EC
* IEC60601-1: 2005 + CORR. 1 (2006) + CORR. 2 (2007); EN 60601-1:2006+AC2010 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
* EN55022: 2006 + A2: 2010, Class B: Information technology equipment-Radio disturbance characteristics -Limits and
methods of measurement
* EN60601-1-2: 2007 CISPR: 2011: Medical electrical equipment: Part 12: General requirements for basic safety and
essential performance-collateral standard electromagnetic compatibility
* EN1060-4: 2004 Non-invasive sphygmomanometers. Test procedures to determine the overall system accuracy of
automated non-invasive sphygmomanometers.
* EN ISO 13485:2003 /AC: 2009:Medical devices - Quality management systems – Requirements for regulatory purposes
(ISO 13485:2003)
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