TBT BSN | Notification

Notification Detail :: G/TBT/N/ISR/1293/Rev.1

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

SI 60601 part 1 – Medical electrical equipment:  General requirements for basic safety and essential performance

Objective

Protection of human health or safety (TBT); Harmonization (TBT)

Product Covered

Medical electrical equipment (HS code(s): 9018; 9019; 9405); (ICS code(s): 11.040)

Document Notification

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HSCODE

9018 - Instruments and appliances used in medical, surgical, dental or veterinary sciences, incl. scintigraphic apparatus, other electro-medical apparatus and sight-testing instruments, n.e.s.; 9019 - Mechano-therapy appliances; massage apparatus; psychological aptitude-testing apparatus; ozone therapy, oxygen therapy, aerosol therapy, artificial respiration or other therapeutic respiration apparatus; 9405 - Luminaires and lighting fittings, incl. searchlights and spotlights, and parts thereof, n.e.s; illuminated signs, illuminated nameplates and the like having a permanently fixed light source, and parts thereof, n.e.s.; 901910 - Mechano-therapy appliances; massage apparatus; psychological aptitude-testing apparatus

ICSCODE

11.040 - Medical equipment

Keywords

Specific Regions

Description

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.

Notified Document

1:File here

Link to Notification

EN:File here

FR:File here

ES:File here

Status Active

No	#	Comment By	Title	Comment Date	File

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Notification Detail :: G/TBT/N/ISR/1293/Rev.1

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