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Homepage>ISO Standards>ISO 5841-2:2014-Implants for surgery — Cardiac pacemakers-Part 2: Reporting of clinical performance of populations of pulse generators or leads
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download between 0-24 hoursReleased: 2014
ISO 5841-2:2014-Implants for surgery — Cardiac pacemakers-Part 2: Reporting of clinical performance of populations of pulse generators or leads

ISO 5841-2:2014

ISO 5841-2:2014-Implants for surgery — Cardiac pacemakers-Part 2: Reporting of clinical performance of populations of pulse generators or leads

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Standard´s number:ISO 5841-2:2014
Pages:26
Edition:3
Released:2014
Language:English
DESCRIPTION

ISO 5841-2:2014


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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