MEDICAL EQUIPMENT, SURGICAL IMPLANTS, PACEMAKERS, DEFINITIONS, MARKING, TESTS,PERFORMANCE TESTS
被代替标准
2001-01-01
适用范围
This National Standard of Canada is equivalent to International Standard ISO 5841-1:1989. 1 Scope and field of application 1.1 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
comformance 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. 1.2 This part of ISO 5841 applies to all types of wholly implantable cardiac
pacemakers; it does not cover anti-tachyarrythmia and defibrillation functions
of pacemakers, nor pacemakers powered by isotopic cells (nuclear-powered
pacemakers).