The follow is a brief overview of applicable standards, along with device settings:
EN45502-1:2015
•Implants for surgery. Active implantable medical devices. General requirements for safety, marking and for information to be provided by the manufacturer, cl. 20.2 Test 1, Figures 1, 2, and 3
•Test settings
•Damped sinus, Vp = 140+7-0V, Tp = 1.5 to 2.5mS, T50 = 3 to 5.5mS
•Source impedance <10 Ohms, output through 300Ohm resistor
•3+ pulse @ 20s, wait 60s, 3-pulse @20s
•Note that "source impedance" is (typically) the ratio of Vo/Io, and is different than RL + RG. Appendix A has additional information (informative) and also includes Fig A1, where component values are specified
ISO 14117:2012
•Active implantable medical devices -- Electromagnetic compatibility -- EMC test protocols for implantable cardiac pacemakers, implantable cardioverter defibrillators and cardiac resynchronization devices, cl. 6.2.2, Test 1, Fig 45 and 46
•Test settings
•Damped sinus, Vp = 380+5-0%, Tp = 1.5 to 2.5mS, T50 = 3 to 5.5mS.
•3+ pulse @ 20s, wait 60s, 3-pulse @20s
•Component values are included as an example, but there is a discrepancy in the output inpedance: 12 Ohms vs. 15 Ohms. Points A and B must be brought to the front panel for Vtest
ISO 14708-1:2014
•Implants for surgery -- Active implantable medical devices -- Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
•Test settings
•Damped sinus, Vp = 140+7-0V, Tp = 1.5 to 2.5mS, T50 = 3 to 5.5mS
•Source impedance <10 Ohms, output through 300Ohm resistor
•3+ pulse @ 20s, wait 60s, 3-pulse @20s
•Note that "source impedance" is (typically) the ratio of Vo/Io
EN 45502-2-2:2008
•Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators), clause 20.2
•Test settings
•Damped sinus, Vp = 380+5-0%, Tp = 1.5 to 2.5mS, T50 = 3 to 5.5mS.
•Component values are included as an example.
•3+ pulse @ 20s, wait 60s, 3-pulse @20s through a resistor network (Fig. 110)
EN 45502-2-1:2003
•Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
•Test settings
•Set for 140 volts
•This standard refers back to EN45502-1:2015 for cl 20.2
EN 45502-2-3:2010
•Active implantable medical devices - Part 2-3: Particular requirements for cochlear and auditory brainstem implant systems
•Test settings
•Set for 140 volts
•This standard refers back to EN45502-1:2015 for cl 20.2
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