I am new to compliance. We make two types of devices, one uses a stepper motor with chopper drive and operates on a 16V, 1500mA rechargeable battery. Its insulated from body. There is not wirelss. The other one is similar to a massage vibrator with wireless control, the vibratory is insulated from skin. I am trying to find out which IEC specifications do I need to comply with. Also trying to find out in general being an electrical engineer designing medical instruments, how to know which compliance rules i need to follow from legal point of view so my device does not interfere with other devices and also its not susceptible to interference from other devices. Thank you for you input.
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compliance for medical device
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