EN 50061:1988 pdf download,Safety of implantable cardiac pacemakers.
This standard EN 50061:1988 specifies safety and other requirementsexclusively for all types of wholly implantable cardiac PACEMAKERS.
This standard EN 50061:1988 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.Appropriatetest methods are given.This standard EN 50061:1988 specifies the requirements for the reliable operation of PACEMAKERS onlyinsofar as they affect safety.
It does not cover the antitachyarrythmia and defibrillationfunctions of PACEMAKERS,nor PACEMAKERS operatedby isotopic cells.

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