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SIST

SIST EN 50061:1995

(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Withdrawn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-1995
Withdrawal Date
19-Apr-2016
ICS
11.040.40 - Implants for surgery, prosthetics and orthotics
Technical Committee
IEMO - Electrical equipment in medical practice
Current Stage
9900 - Withdrawal (Adopted Project)
Start Date
19-Apr-2016
Due Date
12-May-2016
Completion Date
20-Apr-2016
Mandate
BC/CLC/02-89 - BC/CLC/02-89
Ref Project
EN 50061:1988 - Safety of implantable cardiac pacemakers

Relations

Replaced By
SIST 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
01-Dec-2015
Replaced By
SIST EN 45502-2-1:2004 - Active implantable medical devices - Part 2-1: Particular requirements for active implantable medical devices intended to treat bradyarrhythmia (cardiac pacemakers)
Effective Date
01-Dec-2015
Replaced By
SIST 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
Amended By
SIST EN 50061:1995/A1:1998 - Safety of implantable cardiac pacemakers
Effective Date
29-Jan-2023
Amended By
SIST EN 50061:1995/A1:1998 - Safety of implantable cardiac pacemakers
Effective Date
07-Jun-2022
Replaced By
SIST 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
07-Jun-2022
Replaced By
SIST EN 45502-2-1:2004 - 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
SIST EN 50061:1995/A1:1998 - Safety of implantable cardiac pacemakers
Effective Date
01-Sep-1998

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Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 50061:1995
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
SIST EN 50061:1995 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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