Implants for surgery. Cardiac pacemakers - Reporting of clinical performance of populations of pulse generators or leads Ingestion-build-89079 Directive 2006/95/EC of the European

Directive 2006/95/EC of the European Parliament

or installed equipment to measure photon radiation about

Alkali content is defined as the content of sodium oxide (Na2O) and potassium oxide (K2O) in cement

Precision values for all test methods were revised

access to work station

Implants for surgery. Cardiac pacemakers - Reporting of clinical performance of populations of pulse generators or leads Ingestion-build-89079 Directive 2006/95/EC of the European1 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