BS EN ISO 7492:2019 pdf – Dentistry – Dental explorer.
1 Scope This document specifies the dimensions and performance requirements for dental explorers. This document is not applicable to endodontic explorers. 2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements 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 6507-1, Metallic materials — Vickers hardness test — Part 1: Test method ISO 6508-1, Metallic materials — Rockwell hardness test — Part 1: Test method ISO 7153-1, Surgical instruments — Materials — Part 1: Metals ISO 17664, Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices 3? Terms? and? definitions For the purposes of this document, the terms and definitions given in ISO 1942 and the following 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/ 3.1.1 dental explorer handheld dental instrument with a pointed tip designed for tactile examination of tooth surfaces Note 1 to entry: See Figure 1. Note 2 to entry: Dental explorer is used to examine teeth for decay (caries), calculus, furcations, or other abnormalities.
3.1.2 datum point section point between the centreline of the handle, at right angle to the centreline, and the working tip Note 1 to entry: The datum point is where h 1 and h 2 meet. 3.1.3 handle area used for holding the dental explorer (3.1.1) during tactile exploration 3.1.4 shank part of the dental explorer (3.1.1) that connects the working end to the handle 3.1.5 working end part of the dental explorer (3.1.1) after the first bend of the shank including the working tip Note 1 to entry: The working end is the combination of h 1 and h 2 directly on the explorer. 3.1.6 working tip active part of the working end which will be first to contact the tooth surface 3.2 Symbols and abbreviated terms For the purposes of this document, the following symbols and abbreviated terms apply, and are shown in Figure 1 to Figure 9. b length of working tip (only used in Figure 5) h 1 working end height h 2 shank height r working end radius
4 Requirements 4.1 Materials 4.1.1 Material of the working end The working end of a dental explorer shall be made of metallic materials in accordance with ISO 7153-1. 4.1.2 Material of the handle The material of the handle, selected at the discretion of the manufacturer, shall meet the requirements of 4.5, 4.6, and 4.7. 4.2 Location of measurement points The location of the points of measurement for dental explorers shall be as shown in Figure 1 and in Table 1.
4.3 Shape and dimensions The dental explorer shall have one of the forms shown in Figure 2 to Figure 9. Commonly used dimensions are shown in Table 2. The column is arranged according to the increase in the dimension h 1 . The dimensions shall be measured in accordance with Table 1 and Figure 1. The working tip shall be pointed but the exact shape and design of the working end is left to the discretion of the manufacturer. The maximum length of a dental explorer shall be at the manufacturer’s discretion, but it should be noted that overall lengths in excess of 173 mm can cause difficulty in containment within a sterilization cassette.