SIS SS-EN 50 061-1991
Medical electrical equipment - Safety of implantable cardiac pacemakers

Standard No.

SIS SS-EN 50 061-1991

Release Date

1991

Published By

SE-SIS

Latest

SIS SS-EN 50 061-1991

Scope

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.

SIS SS-EN 50 061-1991 history

• 1991 SIS SS-EN 50 061-1991 Medical electrical equipment - Safety of implantable cardiac pacemakers