Committee Information
Preparation of Palestinian Standards projects and participation in the preparation of regional and international standards related to medical devices and supplies that fall under the following definition, including all types of standards such as requirements, definitions, test methods, classification, and others:
Medical device: Any instrument, apparatus, appliance, software, implant, reagent, material, or any other article prepared by its manufacturer to be used for humans—whether used alone or in combination—for one or more of the following specified medical purposes:
- Diagnosis of a disease, prevention, monitoring, prediction, prognosis, treatment, or alleviation of it.
- Diagnosis, monitoring, treatment, or alleviation of any injury or disability that may occur, or compensation for any of them.
- Investigation of anatomical structure or physiological or pathological condition, or replacement or modification of any of them.
- Providing information through laboratory examination of samples derived from the human body, including organ, blood, and tissue donation, which do not achieve their primary intended action in or on the human body by pharmacological, immunological, or metabolic means, but these means can be considered as assisting in their function.
The following products should also be considered medical devices:
- Devices for regulating or enhancing pregnancy.
- Products specifically intended for cleaning, disinfecting, or sterilizing the devices referred to in the definition of a medical device.