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AAMI/ISO 5841-2:2014
Implants for surgery - Cardiac pacemakers - Part 2: Reporting of clinical performance of populations of pulse generators or leadsMore info
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. 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 | ANSI/AAMI/ISO |
|---|---|
| Editor | AAMI |
| Document type | Standard |
| Format | File |
| Confirmation date | 2014-07-21 |
| ICS | 11.040.40 : Implants for surgery, prosthetics and orthotics |
| Cross references | ISO 5841-2 (2014-08), IDT |
| Year | 2014 |
| Document history | |
| Country | USA |
| Keyword | ANSI 5841;ANSI/AAMI/ISO 5841;5841;ANSI/AAMI/ISO 5841-2-2014 |