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.