Hi, dental burs ( for endodontic treatment non vital teeth, no surgery treatment, odonto treatment) are critical or semicritical devices , in the light of MDR.
Dental burs( novital teeth, nosurgery, odontotreatment) must be "sterile" at time of use or it is ok to be only " sterilizated" and keep in a apropriate dental burs holder? Every dental bur ( for nonvital, nosurgery, odontoterapy)must be pack individual with an integrator type 5? Or in a dental burs holder after autoclaving? Thank you very much!
MDR does not have the term critical or semi-critical. All medical devices must be in one of the classes as described in Annex 8 - Classification rules. If I understand your device correctly, it is a reusable medical device, therefore class Ir. According to the definition, a reusable surgical instrument means an instrument intended for surgical use in cutting, drilling, sawing, scratching, scraping, clamping, retracting, clipping, or similar procedures, without a connection to an active device and which is intended by the manufacturer to be reused after appropriate procedures such as cleaning, disinfection, and sterilization have been carried out.
Rule 6 is the rule that covers reusable medical devices, which states that all surgically invasive devices intended for transient use are classified as class IIa unless they are reusable surgical instruments, in which case they are classified as class I.
Reusable devices must be sterile before use. It must be sterilized, and it can be kept in the holder for a certain amount of time. How much time depends on the type of sterilization, disinfection used, a method for preparing the sterilization, and so on. Usually, this time that is allowed for instruments to be stored after the sterilization is defined by the sterilization validation process.
Instruments can be packed individually or for example a set for a certain procedure.