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The draft of the Egyptian standard for "Non –Sterile Ultrasound Gel for external usage " 


Egypt
TBT
2026-06-26
2026-08-25

The draft of the Egyptian standard specifies the requirements for non-sterile ultrasound gel intended for external use only for routine, low-risk examinations, or prior to potential surgery at or within 24 hours of the examination site, provided it is applied only to intact skin.

it does not apply to sterile gel used in direct contact with mucous membranes (e.g., transrectal or transvaginal examinations), examination of internal tissues, open wounds, uninfected skin, critically ill newborns, immunocompromised patients, patients receiving immunosuppressive therapy, intensive care units, and other critical situations requiring high levels of sterility.

Worth mentioning is that this draft standard complies with DARS 2057:2026 Medical ultrasound gel — Specification.


G/TBT/N/EGY/595
原文文档   翻译文档

11.040.20 - Transfusion, infusion and injection equipment

Quality requirements (TBT)

Transfusion, infusion and injection equipment (ICS code(s): 11.040.20)

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