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ISO 5841-2:2014

Current Revision

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

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ISO 5841-2:2014 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. 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.


SDO ISO: International Organization for Standardization
Document Number ISO 5841
Publication Date Not Available
Language en - English
Page Count
Revision Level
Supercedes
Committee ISO/TC 150/SC 6
Publish Date Document Id Type View
Not Available ISO 5841-2:2014 Revision