ISO 23445:2021 pdf download – Dentistry — Tissue punches.
6.4 Resistance to reprocessing There shall be no signs of deterioration in performance or corrosion when tested in accordance with 7.3. 6.5 Hardness The hardness of the tissue punch shall be equal or greater than 400 HV2 or 41 HRC when tested with 7.4. 6.6 Run-out The total indicated run-out shall not exceed 0,1 mm, when tested in accordance of 7.5. 7 Measurement and test methods 7.1 Visual inspection Perform visual examination with normal visual acuity without any magnification. 7.2 Dimensions Measure the dimensions in accordance with ISO 8325:2004, 4.1 to 4.3, and 5.1, 5.2, 5.4, 5.5 and 5.6, as appropriate. The manufacturer shall validate that the accuracy of the measuring device is applicable. The accuracy of measurement device shall be 1/10 of the required tolerance. 7.3 Resistance to reprocessing Carry out 100 reprocessing cycles as specified in the manufacturer’s instructions. The reprocessing cycle shall include the manufacturer’s recommended methods for cleaning, disinfection and sterilization in accordance with ISO 17664. If the manufacturer defines the maximum number of reprocessing cycles less than 100, this number shall be used. Assess visually for any signs of deterioration of the surface, e.g. signs of rust, pitting or any other surface defects, including marking. Repeat the tests for 6.5 and 6.6. Inspect the surfaces in accordance with 7.1. 7.4 Hardness Test the hardness in accordance with either ISO 6507-1 or ISO 6508-1. 7.5 Run-out Determine the run-out by guiding the shank of the instrument, placing a comparator at 1 mm from the tip of the working part and rotating it over 360°. The shank shall be supported at least by 10 mm. Record the minimum and maximum value. The difference of both extrema is defined as the runout.
8 Marking, labelling and instructions for use 8.1 Marking on the tissue punch Marking on the tissue punch shall be in accordance with ISO 13504 with following additional requirements. a) The value of inner diameter (reference diameter) of the working part shall be placed onto the tissue punch. The markings of the diameter shall be marked onto either the working part or the shank in such a way that it is legible without magnification. The process of marking is left to the discretion of the manufacturer, but it shall be permanent. b) The marking with further information, such as length of working part or shank, may be added at the discretion of the manufacturer. It shall be marked on the surface of the instrument in such way that it is legible without magnification and permanent. 8.2 Labelling on the package Labelling on the package shall be in accordance with ISO 13504 with additional requirements of diameter of the tissue punches. The manufacturer shall give information about the recommended and the maximum speed, if not stated in instructions for use. 8.3 Instructions for use Instructions for use shall be in accordance with ISO 13504 with following additional requirements. a) The description shall include the reprocessing method containing cleaning, disinfection and sterilization of the device. b) The manufacturer shall give information about the recommended and the maximum speed.