ISO/TS 18339:2015 PDF

Name: ISO/TS 18339:2015 — Endotherapy devices — Eyepiece cap and light guide connector
SKU: ISO/TS 18339:2015
Price: 25 EUR
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Endotherapy devices — Eyepiece cap and light guide connector

Название (английский):

ISO/TS 18339:2015

Endotherapy devices — Eyepiece cap and light guide connector

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 3
Дата публикации:: 6 ноября 2015 г.
Издание:: ISO TS 18339 edition 1 version 1
ICS:: 11.040.55

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Описание (английский):

ISO/TS 18339:2015 specifies the design of eyepiece cap and light guide connector of an endoscope to enable the combination of products from different manufacturers. The products intended only for limited combination are out of the scope. It is a mechanical connection; it might not generate best results, but it allows the user to be able to work. ISO/TS 18339:2015 supports manufacturers of components in the design of interfaces.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO/TS 18339:2015 - Endotherapy devices: Eyepiece cap and light guide connector - is a technical specification that defines the mechanical interface between endoscopes and proximal accessories (camera couplers and light guide cables). Its purpose is to support interoperability across products from different manufacturers by specifying minimum shape, dimensional and tolerance requirements for eyepiece caps and detachable light guide connectors. The document clarifies that these are mechanical connections intended to enable working combinations, not to guarantee optimal optical performance.

Key topics and technical requirements

Scope and intent: Defines mechanical design requirements to enable combination of components from different manufacturers; items intended only for limited combinations are excluded.

Eyepiece cap design:

Specifies two forms: straight-edged and curved-edged eyepiece caps with minimum shape and dimensional details.
Includes key dimensions such as the proximal output interface diameter (e.g., Ø31.75 −0.1 mm), radii (R3.3, R6.477) and angular features (50° ± 10° and related 10° features) that assure camera coupler fit.

Light guide connector:

Defines the mechanical connector geometry to accept detachable light guide cables; figure details include an aperture (Ø7.55 mm) and thread size M8.5 × 0.5 (nut optional).
Notes that future connectors might use the smaller thread size.

Tolerances: Tolerance class references ISO 2768-1 for linear and angular dimensions.

Safety and performance considerations:

Advises risk management per ISO 14971 when combining components from different sources.
Warns about mismatched fibre-bundle diameters: overly large bundles can cause heating and burns; overly small bundles reduce light output. Recommends reducing light output or selecting a properly sized fibre cable.

Documentation: Product instructions for combined equipment must be followed.

Applications and who uses this standard

Medical device manufacturers designing endoscopes, camera couplers, light guide cables and accessory components to ensure cross-vendor mechanical compatibility.

Component suppliers producing eyepiece caps, light guide connectors or adapters.

Clinical engineering and procurement teams evaluating interoperability and replacement parts for endoscopy suites.

Regulatory and quality personnel integrating risk management and design controls.

Test labs and conformity assessors verifying dimensional compatibility.

Related standards

ISO 2768-1 - General tolerances for linear and angular dimensions

ISO 8600-6 - Vocabulary for medical endoscopes and endotherapy devices

ISO 14971 - Risk management for medical devices

Keywords: ISO/TS 18339:2015, endotherapy devices, eyepiece cap, light guide connector, endoscope compatibility, mechanical interface, light guide cable, M8.5×0.5, ISO 2768-1, ISO 14971.

ISO/TS 18339:2015 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and who uses this standard

Related standards

Технические детали

SIST ISO 2768-1:1999

General tolerances -- Part 1: Tolerances for linear and angular dimensions without individual tolerance indic…

BS/AAMI 34971:2023

Application of ISO 14971 to machine learning in artificial intelligence. Guide.

BS ISO 8600-6:2005

Optics and photonics. Medical endoscopes and endotherapy devices - Vocabulary