1882089

ISO 5841-2:2014

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

standard by International Organization for Standardization , 08/01/2014

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Full Description

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.

 

Product Details

Published:
08/01/2014
Number of Pages:
34
File Size:
1 file , 910 KB
Same As:
AAMI/ISO 5841-2:2014, BS ISO 5841-2:2014
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This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. ISO 5841-2:2014

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

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  2. ISO 5841-2:2000


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

    • Historical Version