ANSI/AAMI/ISO 5841-2:2014
Implants for surgery.Cardiac pacemakers.Part 2: Reporting of clinical performance of populations of pulse generators or leads
- Standard No.
- ANSI/AAMI/ISO 5841-2:2014
- Release Date
- 2014
- Published By
- US-AAMI
- Latest
- ANSI/AAMI/ISO 5841-2:2014
- 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 have to be market approved in one or more geographies. It includes general requirements for ail reports and supplementary requirements for reports on cumulative experience with devices and estimates of future clinical performance for devices,when appropriate.
ANSI/AAMI/ISO 5841-2:2014 history
- 2014 ANSI/AAMI/ISO 5841-2:2014 Implants for surgery.Cardiac pacemakers.Part 2: Reporting of clinical performance of populations of pulse generators or leads
