BS ISO 18340:2020 pdf free.Endoscopes – Trocar pins, trocar sleeves and endotherapy devices for use with trocar sleeves.
BS ISO 18340 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. ISO 8600-1, Endoscopes – – Medical endoscopes and endotherapy devices一Part 1: General requirements ISO 8600-6, Optics and photonics一Medical endoscopes and endotherapy devices一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 s leeve 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 1 to 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.Due to design of endotherapy devices moving parts may protrude. Sheath length shall not cover them. See Figure 6. The maximum insertion portion width OD of the device shall fit to the minimum inner diameter of the trocar sleeve IDts, min To ensure the compatibility to a trocar sleeve the maximum insertion portion width shall not be larger than the nominal diameter.BS ISO 18340 pdf download.