ISR/721/Rev.1
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
2018-04-19
2018-02-21

Medical electrical equipment (HS: 9018, 9019, 9402, 9405, 841370, 841381). (ICS: 11.040.60).

SI 60601 part 2.3 - Medical electrical equipment: Particular requirements for the basic safety and essential performance of short-wave therapy equipment (29 page(s), in English; 6 page(s), in Hebrew)

The draft revision of SI 60601 part 2.3 that was due to replace SI 1011 part 2.3, announced in G/TBT/N/ISR/721 (dated 3 December 2013), was not yet published in Israel Official Gazette and the Standards Institution of Israel (SII) has announced a new draft revision. This new draft revision (December 2016) will replace the old draft after its entry into force. These revision will be published and enter into force as follows:

·         The 2013 draft of SI 60601 part 2.3 will enter into force 90 days after publication in Israel Official Gazette;

·         The 2016 draft of SI 60601 part 2.3 will enter into force 90 days after publication in Israel Official Gazette;

·         These 2 standards will apply from the date of entry into force until 3 June 2019. During this period appliances could be tested according to the 2013 edition or the 2016 edition and comply with either.

·         After 3 June 2019 only the 2016 edition will apply. The 2016 draft revision adopts the International Standard IEC 60601-2-3 - Edition 3.0: 2012-04 and Amendment 1: 2016-04 with a few changes that appear in the standard's Hebrew section.