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Reference to standards contd.
* EN ISO14971:2012: Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected
version 2007-10-01)
* 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 81060R2:2009 NonRinvasive sphygmomanometers – Part 2: Clinical validation of automated
measurement type
* FCC Part 15:2010, Sub part B, Class B: Electromagnetic Compatibility
* EN301489-1 v1.9.2 (2011-09)
* EN301489-3 v1.4.1 (2002-08)
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