GSO 2628:2021

Gulf Standard   Current Edition
· Approved on 01 July 2021 · Edition 1

Medical devices and supplies classification criteria

GSO 2628:2021 Files

Arabic 12 Pages
Current Edition
12.0 OMR
English 8 Pages
Current Edition Reference Language
9.0 OMR

GSO 2628:2021 Scope

This standard is related to the classification of medical devices, by setting a Classification rules to decide whether the product is a medical device or not .Where there exists a difficulty in the uniform application of the classification rules; examples highlighted in the annexure of this standard can facilitate the decision of implementing the classification rules of medical devices which may assist in creating a consistency in the classification method and decisions. This standards does not cover borderline products or combination products.

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