Using Surge Testers for Design Verification and Production Testing

Not only are medical devices expected to function as intended, they must meet ergonomic, safety, FDA and functional requirements. They must be designed to function in adverse environments; sometimes in the operating room; sometimes in an emergency vehicle for example. If a device is patient connected, it is also expected to function within proscribed parameters in the presence of a defibrillation pulse. These parameters differ depending on the type of device. All devices must pass an isolation test designed to ensure that the pulse will not affect the device’s signal input part/signal output part (SIP/SOP) ports; and effective with the Third Edition of IEC 60601-1, they must demonstrate that they absorb less than 10 percent of the defibrillation pulse. ECG monitoring equipment either for hospital (IEC 60601-2-27) or emergency use (IEC 60601-2-25) is additionally subject to performance requirements after a defibrillation pulse is applied.