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“ISO 15223:2025 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements – Amendment 1: Addition of defined term for authorized representative and modified EC REP symbol to not be country or region specific” has been added to your cart. View cart
ISO 5841:2014
ISO 5841:2014 Implants for surgery – Cardiac pacemakers – Part 2: Reporting of clinical performance of populations of pulse generators or leads
CDN $233.00
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.
Edition
3
Published Date
2014-07-29
Status
PUBLISHED
Pages
26
Language
English
Format
Secure PDF
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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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