ISO 5841-2:2014
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ISO 5841-2:2014
60541

Abstract  Preview

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.


General information 

  •  :  Published
     : 2014-08
  •  : 3
     : 26
  •  : ISO/TC 150/SC 6 Active implants
  •  :
    11.040.40 Implants for surgery, prosthetics and orthotics

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal:

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