ISR/1324
WTO/TBT
IL Israël
  • 11 - Technologies de la santé
  • 84 - Réacteurs nucléaires, chaudières, machines, appareils et engins mécaniques; parties de ces machines ou appareils
  • 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
2024-04-29
2024-03-05

Medical electrical equipment: High-frequency surgical equipment and accessories (HS code(s): 841370; 841381; 9018; 9019; 9402; 9405); (ICS code(s): 11.040.30)

SI 60601 part 2.2 - Medical electrical equipment: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories; (18 page(s), in Hebrew)

First amendment to the Mandatory Standard SI 60601 part 2.2. This amendment adopts AMD 1: 2023-02 of the International Standard IEC 60601-2-2:2017 with a few additional national deviations to the standard's Hebrew section.

Both the standard without this amendment and the amended standard will apply from the entry into force of this proposed amendment during a transition period of 4 years. During this time, products may be tested according to both editions.