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
11.5 BHD
English
8 Pages
Current Edition
Reference Language
9.0 BHD
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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