scope:

Scope and field of application

This part of ISO 5841 establishes basic terminology and definitions, and specifies requirements for marking implantable cardiac pacemakers and their packaging.

Minimum requirements for the ability of pacemaker pulse generators to withstand environmental stress conditions are also specified along with appropriate test methods.

Annex A explains the coding system for identifying the mode of operation of pulse generators. Test methods to assess the basic electrical parameters for conformance with claims are included in annex B; annex C describes the estimation and expression of the nominal service life of a pulse generator; annex D provides an example of a technical information sheet; annex E provides a rationale for certain of the provisions of this part of ISO 5841 and annex F provides optional symbols to be used in place of written words.

This part of ISO 5841 applies to all types of wholly implantable cardiac pacemakers; it does not cover antitachyrrythmia and defibrillation functions of pacemakers, nor pacemakers powered by isotopic cells (nuclear-powered pacemakers).