BS EN ISO 3630-5:2020 pdf free.Dentistry – Endodontic instruments.Shaping and cleaning instruments.
BS EN ISO 3630-5 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一Vocabulary ISO 3630-1, Dentistry一Endodontic instruments一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.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.BS EN ISO 3630-5 pdf downlaod.