ISO 5841-2:2000, Implants for surgery — Cardiac pacemakers — Part 2: Reporting of clinical performance of populations of pulse generators or leads

ISO 5841-2:2000, Implants for surgery -- Cardiac pacemakers -- Part 2: Reporting of clinical performance of populations of pulse generators or leads

This part of ISO 5841 specifies requirements for reports on the clinical performance in humans of population samples of pulse generators or leads, intended for long-term implantation as cardiac pacemakers, hereinafter referred to as devices. It includes general requirements for all reports and supplementary requirements for reports on cumulative experience with devices and estimates of future clinical performance for devices, when appropriate.Annex A provides requirements for categorizing device

List Price: $ 109.00

Price: $ 109.00

Filed Under: Lead Generator

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