ISO/TS 18339:2015
(Main)Endotherapy devices - Eyepiece cap and light guide connector
Endotherapy devices - Eyepiece cap and light guide connector
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.
Dispositifs d'endothérapie — Bouchon d'oculaire et raccord de guide de lumière
General Information
- Status
- Published
- Publication Date
- 05-Nov-2015
- Technical Committee
- ISO/TC 172/SC 5 - Microscopes and endoscopes
- Drafting Committee
- ISO/TC 172/SC 5/WG 6 - Endoscopes
- Current Stage
- 9060 - Close of review
- Completion Date
- 02-Dec-2028
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.
Frequently Asked Questions
ISO/TS 18339:2015 is a technical specification published by the International Organization for Standardization (ISO). Its full title is "Endotherapy devices - Eyepiece cap and light guide connector". This standard covers: 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.
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.
ISO/TS 18339:2015 is classified under the following ICS (International Classification for Standards) categories: 11.040.55 - Diagnostic equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO/TS 18339:2015 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
TECHNICAL ISO/TS
SPECIFICATION 18339
First edition
2015-11-01
Endotherapy devices — Eyepiece cap
and light guide connector
Dispositifs d’endothérapie — Bouchon d’oculaire et raccord de
guide de lumière
Reference number
©
ISO 2015
© ISO 2015, Published in Switzerland
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any form
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ii © ISO 2015 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Dimensions . 1
4.1 Eyepiece cap . 1
4.1.1 Eyepiece cap with straight edges . 1
4.1.2 Eyepiece cap with curved edges . 2
4.2 Light guide connector . 3
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
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committee has been established has the right to be represented on that committee. International
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ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of
electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 172, Optics and photonics, Subcommittee SC 5,
Microscopes and endoscopes.
iv © ISO 2015 – All rights reserved
Introduction
To carry out minimal invasi
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