Medical electrical equipment - Cardiac defibrillators; (HS: 9018; 9402); (ICS: 11.040.10)

SI 60601 part 2.4 - Medical electrical equipment: Particular requirements for the basic safety and essential performance of cardiac defibrillators (95 page(s), in English; 7 page(s), in Hebrew)

Revision of the Mandatory Standard SI 60601 part 2.4 dealing with cardiac defibrillators. This draft standard revision adopts the International Standard IEC 60601-2-4 - Edition 3.0: 2010-12 and Amendment 1: 2018-02. The major changes included in this revision are due to the adoption of the new amendment to the international standard. Both the old standard and the new revised standard will apply from entry into force of this revision for a period of 3 years. During this time devices may be tested either according to the old or the new revised standard.