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ISO 5841-2:2014
Implants for surgery — Cardiac pacemakers — Part 2: Reporting of clinical performance of populations of pulse generators or leadsMore info
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.
| Author | ISO/TC 150/SC 6 Active implants |
|---|---|
| Editor | ISO |
| Document type | Standard |
| Format | Paper |
| Edition | 3 |
| ICS | 11.040.40 : Implants for surgery, prosthetics and orthotics |
| Number of pages | 26 |
| Replace | ISO 5841-2:2000 |
| Weight(kg.) | 0.1442 |
| Year | 2014 |
| Country | Switzerland |