ISO 23445-2021 pdf free download – Dentistry — Tissue punches.
This document specifies requirements and their test methods for tissue punches used with a handpiecein dentistry especially for oral surgical implant procedures, such as cutting holes or notches in andremoving of gingival tissue. It also specifies the requirements for their marking and labelling.
2Normative references
The following documents are referred to in the text in such a way that some or all of their contentconstitutes requirements of this document. For dated references, only the edition cited applies. Forundated references, the latest edition of the referenced document (including any amendments) applies.ISo 1797, Dentistry — Shanks for rotary and oscillating instruments
ISO 1942, Dentistry — Vocabulary
lSO 6507-1, Metallic materials — Vickers hardness test — Part 1: Test methodlSO 6508-1, Metallic materials — Rockwell hardness test — Part 1: Test methodISO 8325:2004, Dentistry — Test methods for rotary instruments
ISO 13504,Dentistry — General requirements for instruments and related accessories used in dentalimplant placement and treatment
ISO 16443, Dentistry —Vocabulary for dental implants systems and related procedure
ISO 17664,Processing of health care products — Information to be provided by the medical devicemanufacturer for the processing of medical devices
lSO 21850-1, Dentistry — Materials for dental instruments — Part 1: Stainless steel
3Terms and definitions
For the purposes of this document, the terms and definitions given in IS0 1797,IS0 1942,IS0 16443and the following apply.
ISO and lEC maintain terminological databases for use in standardization at the following addresses:-lSo online browsing platform: available at https://www.iso.org/obp
一IEC Electropedia: available at http://www.electropedia.org/
3.1
tissue punch
instrument for removal of a disk of soft tissue[SOURCE: ISO 16443:2014,3.3.8]
6 Requirements6.1Selection of metals
The metals of the tissue punch shall be in accordance with ISO 21850-1.6.2Surface finish
Surface treatment shall be left to the discretion of the manufacturer. The surfaces of the tissue punchshall be free of visible surface defects when tested in accordance with 7.1.
6.3 Dimensions
6.3.1 Diameter of the working part and centre-guide
Inner diameter of the working part (D2) shall be specified, and shall be within ±0,1 mm of themanufacturer’s stated value when measured in accordance with 7.2.
For type 2, the diameter of centre-guide shall be specified, and shall be within ±0,1 mm of themanufacturer’s stated value when measured in accordance with 7.2.
6.3.2 Length of the working part
The length of the working part shall be within ±0,5 mm of the manufacturer’s stated value whenmeasured in accordance with 7.2.
6.3.3overall length
The maximum overall length shall be left to the discretion of the manufacturers.6.3.4 Dimensions of the shank
The dimensions of the shank shall be in accordance with lS0 1797 when measured in accordance with 7.2.
6.4Resistance to reprocessing
There shall be no signs of deterioration in performance or corrosion when tested in accordance with 7.3.6.5Hardness
The hardness of the tissue punch shall be equal or greater than 400 HV2 or 41HRC when tested with 7.4.6.6Run-out
The total indicated run-out shall not exceed 0,1 mm, when tested in accordance of 7.5.
7Measurement and test methods
7.1Visual inspection
Perform visual examination with normal visual acuity without any magnification.7.2Dimensions
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, asappropriate. 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.
7.3Resistance to reprocessing
Carry out 100 reprocessing cycles as specified in the manufacturer’s instructions. The reprocessingcycle shall include the manufacturer’s recommended methods for cleaning,disinfection and sterilizationin accordance with ISO 17664.
lf the manufacturer defines the maximum number of reprocessing cycles less than 100, this numbershall be used.
Assess visually for any signs of deterioration of the surface,e.g. signs of rust, pitting or any other surfacedefects, including marking. Repeat the tests for 6.5 and 6.6.
Inspect the surfaces in accordance with 7.1.ISO 23445 pdf download.