BS EN ISO 3630‑5:2020 pdf – Dentistry — Endodontic instruments Part 5: Shaping and cleaning instruments.
1 Scope This document specifies requirements and test methods for hand‑held and mechanically operated instruments used for shaping and cleaning root canals, and which are not specified in other parts of the ISO 3630 series. This document specifies requirements for size, marking, product designation, safety considerations, labelling and packaging. 2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 1942, Dentistry — Vocabulary ISO 3630‑1, Dentistry — Endodontic instruments — Part 1: General requirements 3? Terms? and? definitions For the purposes of this document, the terms and definitions given in ISO 1942 and ISO 3630‑1 apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses: — ISO Online browsing platform: available at https://www.iso.org/obp — IEC Electropedia: available at http://www.electropedia.org/ 4? Classification For the purposes of this document, shaping and cleaning instruments are classified into five classes, as specified in ISO 3630‑1:2019, Clause 4. 5 Requirements 5.1 Material The materials used for the working part, the shank and the handle of shaping and cleaning instruments are left to the discretion of the manufacturer but shall meet the requirements of ISO 3630‑1:2019, 5.7.
5.5 Color‑coding When color‑coding is included for size or taper, the colour shall comply with the requirements specified in ISO 3630‑1:2019, 5.2.3, 5.3.6, 5.3.7, 5.4.3, 5.5.5, and 5.6.3. 6 Sampling Test ten similar Class shaping and cleaning instruments of each size. If all ten samples pass, the product passes. If eight or fewer samples pass, the product fails. If nine samples pass, test 10 additional samples. When 10 additional samples are required to be tested, all 10 shall pass for the product to comply. 7 Measurement and test methods 7.1 General Test methods are specified in ISO 3630‑1:2019, Clause 7. 8 Resistance to reprocessing Endodontic instruments may be reusable or single use. The manufacturer shall provide a method of reprocessing for endodontic instruments not marked as single use. Test 10 instruments against this method. All 10 instruments shall be in accordance with the requirements from 5.1 through 5.5. Carry out the number of reprocessing cycles permitted in the manufacturer’s instructions. If the manufacturer makes no indication of the number of reprocessing cycles permitted, carry out 10 cycles. NOTE For the purpose of this test a reprocessing cycle includes the manufacturer’s recommended methods of cleaning, disinfection and sterilization, as appropriate. After completing the reprocessing cycles, carry out a visual inspection, as in 7.1, for signs of surface defect or corrosion. 9? Designation,? marking,? and? identification The nominal sizes of shaping and cleaning instruments shall be marked on the handle or shank. Identification symbols shall comply with the requirements specified in ISO 3630‑1:2019, Clause 8.
10 Packaging Packaging for shaping and cleaning instruments shall comply with the requirements specified in ISO 3630‑1:2019, Clause 9. 11 Instructions for use Instructions for use for shaping and cleaning instruments shall comply with the requirements specified in ISO 3630‑1:2019, Clause 10. 12 Labelling Labelling for shaping and cleaning instruments shall comply with the requirements specified in ISO 3630‑1:2019, Clause 11.