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EN 50061:1988

(Main)

Safety of implantable cardiac pacemakers

Safety of implantable cardiac pacemakers

This standard specifies safety and other requirements exclusively for all types of wholly implantable cardiac Pacemakers. This standard also establishes basic terminology and definitions and includes requirements for the marking of pacemakers and their packaging. In addition, minimum requirements are specified for the ability of pacemakers to withstand environmental stress conditions. Appropriate test methods are given. This standard specifies the requirements for the reliable operation of pacemakers only insofar as they affect safety. It does not cover the antitachyarrythmia and defibrillation functions of pacemakers, nor pacemakers operated by isotopic cells

Sicherheit implantierbarer Herzschrittmacher

Sécurité des stimulateurs cardiaques implantables

Safety of implantable cardiac pacemakers

General Information

Status
Withdrawn
Publication Date
30-Apr-1988
Withdrawal Date
31-Dec-1988
Technical Committee
CLC/TC 62 - Electrical equipment in medical practice
Drafting Committee
IEC/SC 62D - IEC_SC_62D
Parallel Committee
IEC/SC 62D - IEC_SC_62D
Current Stage
9960 - Withdrawal effective - Withdrawal
Start Date
01-May-2010
Completion Date
01-May-2010
Mandate
BC/CLC/02-89 - BC/CLC/02-89
Ref Project
SIST EN 50061:1995 - Safety of implantable cardiac pacemakers

Relations

Replaced By
EN 45502-2-2:2008 - Active implantable medical devices - Part 2-2: Particular requirements for active implantable medical devices intended to treat tachyarrhythmia (includes implantable defibrillators)
Effective Date
28-Jan-2023
Replaced By
EN 45502-2-1:2003 - Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
Effective Date
07-Jun-2022
Amended By
EN 50061:1988/A1:1995 - Safety of implantable cardiac pacemakers
Effective Date
29-Jan-2023

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Standards Content (Sample)


SLOVENSKI STANDARD
01-maj-1995
Safety of implantable cardiac pacemakers
Safety of implantable cardiac pacemakers
Sicherheit implantierbarer Herzschrittmacher
Sécurité des stimulateurs cardiaques implantables
Ta slovenski standard je istoveten z: EN 50061:1988
ICS:
11.040.40 Implantanti za kirurgijo, Implants for surgery,
protetiko in ortetiko prosthetics and orthotics
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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