ISO 5841-2:2014

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

Publication date:   Jul 29, 2014

General information

90.93 Standard confirmed   Dec 12, 2019

ISO

ISO/TC 150/SC 6 Active implants

International Standard

11.040.40   Implants for surgery, prosthetics and orthotics

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Scope

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.

Life cycle

PREVIOUSLY

Revises
ISO 5841-2:2000

NOW

PUBLISHED
ISO 5841-2:2014
90.93 Standard confirmed
Dec 12, 2019