ISO 18340:2020 PDF
Endoscopes — Trocar pins, trocar sleeves and endotherapy devices for use with trocar sleeves
Endoscopes — Trocar pins, trocar sleeves and endotherapy devices for use with trocar sleeves
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 9
- Дата публикации:
- 15 июля 2020 г.
- Издание:
- ISO IS 18340 edition 1 version 1
- ICS:
- 11.040.55
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.
Abstract
Overview
ISO 18340:2020 - Endoscopes: Trocar pins, trocar sleeves and endotherapy devices for use with trocar sleeves specifies design, testing and labelling requirements for universally interchangeable and reusable trocar pins, trocar sleeves and endotherapy devices. The standard sets minimum production requirements to ensure compatibility, safety and reliable performance when these components are used with medical endoscopes.
Key topics and technical requirements
- Scope and purpose: Requirements cover design, testing and labelling for trocar assemblies and endotherapy instruments intended to be mutually compatible and reusable.
- Dimensions and compatibility:
- Defines key dimensional terms: nominal diameter (ND), minimum inner diameter (IDts,min), maximum insertion portion width (OD).
- Compatibility rule: OD of an endotherapy device must be ≤ IDts,min of the trocar sleeve; OD must not exceed the nominal diameter.
- Dimensional tolerances (Table 1):
- If ND
Технические детали
- Технический комитет
- ISO/TC 172/SC 5 - Microscopes and endoscopes
- SKU
- ISO 18340:2020
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