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EVS-EN 50061:2002

Safety of implantable cardiac pacemakers

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Kehtetu alates 09.09.2004
Alusdokumendid
EN 50061:1988+A1:1995
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Standardi ajalugu

Staatus
Kuupäev
Tüüp
Nimetus
08.05.2008
Põhitekst
09.09.2004
Põhitekst
Põhitekst
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.
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