In this article, we are going to give you the list of 2017/745 MDR Harmonized Standards and their latest updates.
First of all, we would like to give you the basic definitions about this harmonization system.
This list is going to be updated day by day but before getting started check from the official page for the latest list of harmonized standards.
Harmonized standards are the European Standards created by European Standard Organizations (CEN, CENELEC) in reaction to a order allowed by the European Commission after interview with the Member States. They are distributed within Official Journal of the European Union They take into consideration the essential requirements of mandates and controls, and they are the best degree for a manufacturer/importer to demonstrate suggested similarity of their item with the pertinent directive/regulation.
In order to ensure sterility, knowledge of the levels and types of contamination in used surgical instruments is a primary requirement. Sterility is determined by
Product Recall; It is a voluntary withdrawal or recall from the market by the manufacturer of the device for technical and medical reasons, depending on
Stress (tension) is one of two measurable engineering quantities important in understanding the durability or fatigue life of a product. Surgical power tool systems are
Errors resulting from the cleaning process of surgical power tool systems not only pose risks to the patient. Users also have losses. In this article,
Surgical Power Tool Systems are devices that complete their preparation for use by sterilising at 135 degrees due to their area of use and design.
