ISR/1293/Rev.1
WTO/TBT
IL Israël
  • 11 - Technologies de la santé
  • 90 - Instruments et appareils d'optique, de photographie ou de cinématographie, de mesure, de contrôle ou de précision; instruments et appareils médico-chirurgicaux; parties et accessoires de ces instruments ou appareils
  • 94 - Meubles; mobilier médico-chirurgical; articles de literie et similaires; appareils d'éclairage non dénommés ni compris ailleurs; lampes-réclames, enseignes lumineuses, plaques indicatrices lumineuses et articles similaires; constructions préfabriquées
2024-07-21
2024-06-03

Medical electrical equipment (HS code(s): 9018; 9019; 9405); (ICS code(s): 11.040)

SI 60601 part 1 – Medical electrical equipment: General requirements for basic safety and essential performance; (860 page(s), in English), (11 page(s), in Hebrew)

Revision of the Mandatory Standard SI 60601 part 1, dealing with medical electrical equipment. This draft standard revision adopts the International Standard IEC 60601-1 – Edition 3.2: 2020-08 with a few changes in the normative references that appear in the standard's Hebrew section.

The major differences between the old version and this new revised draft standard are an outcome of adopting Amendment 2 to the International Standard. Both the old standard and the new proposed standard will apply from the entry into force of this revision for a transition period of 1 year. During this time, medical electrical equipment may be tested according to any of these standards.