ISR/1293/Rev.1
WTO/TBT
IL Israel
  • 11 - Health care technology
  • 90 - Optical, photographic, cinematographic, measuring, checking, precision, medical or surgical instruments and apparatus; parts and accessories thereof
  • 94 - Furniture; bedding, mattresses, mattress supports, cushions and similar stuffed furnishings; lamps and lighting fittings, not elsewhere specified or included; illuminated signs, illuminated name-plates and the like; prefabricated buildings
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.