Active standard | Published: 29/07/2014

ISO 5841-2:2014-ed.3.0

Implants for surgery — Cardiac pacemakers — Part 2: Reporting of clinical performance of populations of pulse generators or leads
(Implants chirurgicaux — Stimulateurs cardiaques — Partie 2: Établissement d´un rapport concernant le fonctionnement clinique de populations de générateurs d´impulsions ou de fils-électrodes)

Available languages: English

Available design: electronic design (pdf), Print design

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Detail information

Designation: ISO 5841-2:2014-ed.3.0

Publication date: 29/07/2014

Pages: 26

Country: International technical standard

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Anotation

Description / Abstract: 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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