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. Appropiate 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.