BS EN ISO 3630‑5:2020 pdf download.Dentistry — Endodontic 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.
5.3.2 Stiffness
NOTE The stiffness is tested as resistance to bending.
The shaping and cleaning instrument shall not fracture and the maximum value given shall not be
exceeded, as follows:
a) for Class 1 (standard) instruments in Table 4;
b) for Class 2 (taper) instruments in Table 5;
c) for Class 3 (non‑taper) instruments in Table 4;
d) for Class 4 (non‑uniform taper) instruments in Table 5;
e) for Class 5 (shape) instruments in Table 6.
5.3.3 Handle or plastics shank security
The handle or plastics shank shall meet the requirements given in ISO 3630‑1:2019, 5.8.3.
5.4 Chemical
5.4.1 Resistance to corrosion
The shaping and cleaning instrument shall meet the requirements given in ISO 3630‑1:2019, 5.10.
5.4.2 Heat effects of sterilization
The shaping and cleaning instrument shall meet the requirements given in ISO 3630‑1:2019, 5.10.
After performing the test as specified in ISO 3630‑1:2019, 5.9, the shaping and cleaning instrument shall meet the requirements given in 5.3 above.
Shaping and cleaning instruments identified as “For single use”, and which are delivered in a sterile state, are excluded from the requirements of ISO 3630‑1:2019, 7.7.
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.BS EN ISO 3630‑5 pdf download.