BS ISO 18340:2020 Endoscopes — Trocar pins, trocar sleeves and endotherapy devices for use with trocar sleeves

BS ISO 18340:2020 Endoscopes — Trocar pins, trocar sleeves and endotherapy devices for use with trocar sleeves. 1 Scope This document specifies the design, testing and labelling of trocar sleeves and trocar pins that are universally interchangeable and reusable. It also specifies the design, testing and labelling of endotherapy devices which are inserted through these trocar sleeves and are also universally interchangeable and reuseable. This document specifies the minimum requirements for the production of the products mentioned. 2 Normative references The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. IS086004, Endoscope.s — Medical endo.scopes and endotherapy devices — Pare 1: Genera! requirements ISO 8600-6. Optics and pho tonics — Medical endoscopes and endotherapy devices — Part 6: Vocabulary 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 8600-6 and the following apply. 3.1 trocar endotherapy device consisting of two elements: trocar pin and trocar sleeve to gain internal access and perform endoscopy 3.2 trocar pin endoscopic element with a sharp pyramidal or conical point, typically assembled and used together with a compatible trocar sleeve filling its lumen which allow the introduction of this assembly, used to puncture body cavities 3.3 trocar sleeve endoscopic element used together with a trocar pin to create an artificial orifice for puncturing body cavities 3.4 puncture point tip of a trocar pin Note ito entry: It may have various designs: conical or pyramidal, sharp or blunt or spiral shape driven. 3.5 distal part different kind of movable jaw parts at the end of an endoscope or an endotherapy device 4.4 Endotherapy device with spring handle for use through a trocar sleeve There are also devices (forceps etc.) with “spring handle” available. These devices have branches without joint, see Figure 7. In this case the inner part has to be moved forward within the sheath to open the branches, or the sheath has to be moved backwards for opening. This means, the user has to take care of the relative movement of the distal part. Another issue is the maximum opening of the branches, which is smaller compared to the branches with joint. The length of closed branches L bc is shorter than the length...