Implants for surgery. Cardiac pacemakers - Reporting of clinical performance of populations of pulse generators or leads not-for-sale These electrical test methods include

These electrical test methods include all those previously contained in HD 21 and HD 22

in particular with Section 8

Sink and float

— defines smoking parameters and specifies the standard conditions to be provided for the routine analytical machine smoking of cigarettes

Guided three-jaw industrial chuck

Implants for surgery. Cardiac pacemakers - Reporting of clinical performance of populations of pulse generators or leads not-for-sale These electrical test methods include1 Scope This part of ISO 5841 specifies requirements for reports on the clinical performance in humans of population samples of cardiac pulse generators or leads, intended for long term implantation, hereinafter referred to as devices. Devices to be reported has to be market approved in one or more geographies. It includes general requirements for all reports and supplementary requirements for reports on cumulative experience with devices and