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According to RKI there are five classifications that apply to dentistry:
Non-critical medical devices that only come into contact with intact skin, e.g. extraoral parts of the facebow, callipers, mixing spatulas.
Semicritical A: Medical devices that come into contact with mucous membranes or pathologically changed skin. Without special reprocessing requirements: Hand instruments for general, preventative, restorative or orthodontic (non-invasive) measures. Additional devices without leakage of liquids and/or air or particles, e.g. mouth mirrors, forceps, filling instruments, impression plates.
Semicritical B: Medical devices that come into contact with mucous membranes or pathologically modified skin. With increased reprocessing requirements: rotating or oscillating instruments, transfer instruments for general, preventative, restorative or orthodontic treatment. Auxiliary equipment with liquid and/or air or particle leakage, e.g. handpieces and contra-angles, turbines, diamond and rose drills.
Critical A: Medical devices which penetrate the skin or mucous membrane and come into contact with blood, internal tissue or organs and medical devices for the administration of blood, blood products and other sterile medicinal products. Without special requirements for reprocessing: Instruments and aids for surgical, periodontological or endodontic (invasive) measures, e.g. mouth mirrors, forceps, scalpels, retractors, root elevators.
Critical B: Medical devices which penetrate the skin or mucous membrane and come into contact with blood, internal tissue or organs and medical devices for the administration of blood, blood products and other sterile medicinal products. With increased requirements for reprocessing: rotating or oscillating instruments, transfer instruments for surgical, periodontological or endodontic measures, e.g. (surgical) handpieces and contra-angles, surgical instruments for the treatment of root canals. drills, suction cannulas.
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Guideline issued by the DGKH, DGSV and AKI for the validation and routine monitoring of machine cleaning and disinfection processes also covers the dental field and provides concrete guidelines for validation based on the EN ISO 15883 standard. In principle, the authors of the guideline consider performance testing to be indispensable. Only with validation documents can the requirement of the MD Operator Ordinance for the use of validated procedures of cleaning and disinfection if necessary be met. For the periodicity of the renewed performance test, the guideline recommends that it should be carried out annually.