ISO-5841-2 › Implants for surgery - Cardiac pacemakers - Part 2: Reporting of clinical performance of populations of pulse generators or leads

ISO-5841-2 - 3RD EDITION - CURRENT
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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.

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11.040.40 (Implants for surgery, prosthetics and orthotics Including pacemakers Ophthalmic implants, see 11.040.70)

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Document Number

ISO 5841-2:2014

Revision Level

3RD EDITION

Status

Current

Publication Date

Aug. 1, 2014

Committee Number

ISO/TC 150/SC 6