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CARDIO MEDICAL DEVICE PACKAGE

     

ANSI/AAMI/ISO 81060-2, ANSI/AAMI/IEC 60601-2-47, ANSI/AAMI EC53, ANSI/AAMI EC12, ANSI/AAMI EC57, ANSI/AAMI EC11, ANSI/AAMI BP22, ANSI/AAMI/IEC 60601-2-4...

This Cardiovascular Medical Device Package includes the safety, monitoring and performance requirements for the more frequently used cardio medical devices. The package consists of standards that envelope cardiac monitors, sphygmomanometers, electrocardiographs, ECG cables / lead wires / electrodes, blood pressure transducers and defibrillator devices. This 10 standard Cardiovascular Medical Device package is essential. This collection contains the following AAMI documents:

  • ANSI/AAMI/IEC 60601-2-4:2010 (R2015)
  • ANSI/AAMI/IEC 60601-2-27:2011
  • ANSI/AAMI/IEC 60601-2-47:2012
  • ANSI/AAMI/ISO 81060-2:2013
  • ANSI/AAMI EC53:2013 (ANSI/AAMI EC 53:2013)
  • ANSI/AAMI EC57:2012 (ANSI/AAMI EC 57:2012)
  • ANSI/AAMI EC12:2000 (R2015)
  • ANSI/AAMI EC11:1991/(R)2001 (Historical Standard)
  • ANSI/AAMI BP22:1994 (R2011) (ANSI/AAMI BP 22:1994 (R2011))
  • ANSI/AAMI EC71:2001(R2013) (ANSI/AAMI EC 71:2001(R2013))

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