First amendment to the Mandatory Standard SI 60601 part 2.6. This amendment adopts AMD 2: 2022-09 of the International Standard IEC 60601-2- 6:2012 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.
Draft resolution 1293, 28 November 2024; (1 page(s), in Portuguese)
Medical Devices; General and Plastic Surgery Devices; Classification of Certain Solid Wound Dressings; Wound Dressings Formulated as a Gel, Creams, or Ointment; and Liquid Wound Washes; (29 page(s), in English)
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