EN 50061:1988

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• Status: Withdrawn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

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.

----------
...