Committee Information
Preparation of Palestinian Standards projects and participation in the preparation of regional and international standards related to medical laboratories, including all types of standards such as requirements, definitions, test methods, classification, and others related to medical laboratory systems, their diagnostic medical laboratory devices, and medical laboratory tests.
An in vitro diagnostic medical device is defined as any medical device considered a reagent, reagent product, calibrator, control material, part, apparatus, software, or system, whether used alone or as part of a set, designed by its manufacturer for use in the laboratory to examine samples consisting exclusively or primarily of blood, donated tissues, or derivatives from the human body, for the purpose of providing information for one or more of the following purposes:
- Concerning a physiological or pathological process or condition.
- Concerning congenital physical or mental defects.
- Concerning the predisposition to a medical condition or disease.
- Determining safety and compatibility with potential recipients.
- Predicting treatment response or reactions.
- Identifying or monitoring therapeutic measures.
Sample containers, devices for self-testing, devices for near-patient testing, and companion diagnostics are also considered in vitro diagnostic medical devices.