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ISO Technical Committee for Specifications of Anaesthetic and Respiratory Equipment Endorses SFDA Proposals

2022-07-24

International Organization for Standardization (ISO) Technical Committee for Specifications of anaesthetic and respiratory equipment approved several proposals submitted by the Saudi Food and Drug Authority (SFDA), during the committee’s meetings held from July 11 to 15 in St. Johns, Canada.
The committee’s endorsement of the Kingdom of Saudi Arabia’s proposals was made following scientific and technical discussion. The proposals included the inclusion of requirements for conducting clinical studies in the pre- and post-marketing stages of medical supply systems, modification of the nomenclature and method of testing the internal pressure and non-rupture resistance of anesthesia bags, and taking into account medical dictionaries and terminologies in determining the elements of identifying information and medical terms used in display screens for artificial respiration devices, anesthesia, and resuscitation equipment.
The meetings witnessed the participation of representatives of the member states of the International Technical Committee from the US, Britain, France, Germany, Canada, Australia, New Zealand, and other countries.
SFDA represents Saudi Arabia in the meetings of (16) international technical committees in the International Standardization Organization (ISO) and the International Electrotechnical Commission (IEC), as these committees are concerned with the standard specifications for medical equipment and supplies.

Medical Devices