Implants for surgery. Cardiac pacemakers - Reporting of clinical performance of populations of pulse generators or leads Ingestion-build-86103 BS ISO 4254-9:2008 Agricultural machinery

BS ISO 4254-9:2008 Agricultural machinery

The statements made in this document apply to the development and manufacture for MEMS resonators

As the newest in ISO’s important stable of management standards

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Implants for surgery. Cardiac pacemakers - Reporting of clinical performance of populations of pulse generators or leads Ingestion-build-86103 BS ISO 4254-9:2008 Agricultural machineryPart two 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.