TBT BSN | Notification

Notification Detail :: G/TBT/N/ISR/1324

Notification No.

Notification Type

Notifying Member

Date of Notification

Final Date for Comments

Days to Final Date

Title

SI 60601 part 2.2 - Medical electrical equipment: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

Objective

Harmonization (TBT); Reducing trade barriers and facilitating trade (TBT); Protection of human health or safety (TBT)

Product Covered

Medical electrical equipment: High-frequency surgical equipment and accessories (HS code(s): 841370; 841381; 9018; 9019; 9402; 9405); (ICS code(s): 11.040.30)

Document Notification

Link to ePing

HSCODE

841370 - Centrifugal pumps, power-driven (excl. those of subheading 8413.11 and 8413.19, fuel, lubricating or cooling medium pumps for internal combustion piston engine and concrete pumps); 841381 - Pumps for liquids, power-driven (excl. those of subheading 8413.11 and 8413.19, fuel, lubricating or cooling medium pumps for internal combustion piston engine, concrete pumps, general reciprocating or rotary positive displacement pumps and centrifugal pumps of all kinds); 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; 9402 - Medical, surgical, dental or veterinary furniture, e.g. operating tables, examination tables, hospital beds with mechanical fittings and dentists' chairs; barbers' chairs and similar chairs having rotating as well as both reclining and elevating movement; parts thereof; 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.

ICSCODE

11.040.30 - Surgical instruments and materials

Keywords

Specific Regions

Description

First amendment to the Mandatory Standard SI 60601 part 2.2. This amendment adopts AMD 1: 2023-02 of the International Standard IEC 60601-2-2:2017 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.

Notified Document

1:File here

Link to Notification

EN:File here

ES:File here

Status Active

No	#	Comment By	Title	Comment Date	File

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Notification Detail :: G/TBT/N/ISR/1324

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