ISO 8600-3:2019 PDF

Name: ISO 8600-3:2019 — Endoscopes — Medical endoscopes and endotherapy devices — Part 3: Determination of field of view and direction of view of endoscopes with optics
SKU: ISO 8600-3:2019
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Endoscopes — Medical endoscopes and endotherapy devices — Part 3: Determination of field of view and direction of view of endoscopes with optics

Название (английский):

ISO 8600-3:2019

Endoscopes — Medical endoscopes and endotherapy devices — Part 3: Determination of field of view and direction of view of endoscopes with optics

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 8
Дата публикации:: 29 июля 2019 г.
Издание:: ISO IS 8600 edition 2 version 1
ICS:: 11.040.55

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Описание (английский):

This document applies to endoscopes designed for use in the practice of medicine. It specifies measurement requirements and describes two test methods for measuring the field of view and direction of view of endoscopes. Method A uses the distance from the distal window to calculate the field of view. Method B uses the distance from the entrance pupil. Other test methods can be used if they obtain equivalent results.

Abstract

Похожие стандарты

Упомянутые в описании и другие стандарты ISO

Overview

ISO 8600-3:2019 - "Endoscopes - Medical endoscopes and endotherapy devices - Part 3" defines standardized measurement methods for the field of view (FOV) and direction of view of medical endoscopes with optics. The standard applies to endoscopes used in clinical practice and specifies two principal test methods (Method A and Method B), measurement accuracy requirements (per ISO 8600-1), apparatus, test procedures and required test report content.

Key topics and requirements

Two test methods

Method A (distal window reference): Calculates FOV using the distance from the distal window (typical for many rigid and flexible endoscopes). Applicable when the measuring distance is at least 30× the distance between the distal end and the entrance pupil to avoid systematic error.
Method B (entrance pupil reference): Uses the entrance pupil as the distance reference and can be used at any test distance - recommended for capsule endoscopes, close-focus designs, and where Method A’s assumptions fail.

Apparatus and targets

Optical bench or equivalent with centring and distance adjustment (0–50 mm ±0.2 mm for Method A; capability to position concentric target circles for Method B).
Targets: Method A uses circular targets scaled for 50 mm (major marks every 10°); Method B uses two concentric circles (recommended radii 18 mm and 9 mm) with crosshair.
Illumination: White light target illumination sufficient to identify target details; can be delivered via endoscope lighting or external source.

Measurement tolerances and accuracy

Follow measurement accuracy requirements of ISO 8600-1.
Specific tolerances in procedures: 50 mm ±0.2 mm placement, distal window within 0.5 mm for Method B steps, and manufacturer-specified measuring distances ±1% if relevant.

Test report essentials

Standard reference, endoscope type/manufacturer/model/serial, method used, measuring distances, measured FOV and direction of view with 95% confidence uncertainties, lab and engineer details, date/place, and any deviations.

Applications and users

Who uses it: endoscope manufacturers, optical and medical device test laboratories, R&D teams, quality assurance engineers, notified bodies and regulators assessing device performance, and procurement/specification teams.

Practical use cases: verifying product specifications, design validation, comparative performance testing (FOV and viewing angle), regulatory submissions, and supplier quality agreements for medical endoscopes and endotherapy devices.

Related standards

ISO 8600-1 - General requirements for medical endoscopes (measurement accuracy reference).

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

Keywords: ISO 8600-3:2019, endoscopes, field of view, direction of view, entrance pupil, distal window, Method A, Method B, medical endoscopes, test methods, endotherapy devices.

ISO 8600-3:2019 PDF

Abstract

Похожие стандарты

Overview

Key topics and requirements

Applications and users

Related standards

Технические детали

ISO 8600-1:2013

Endoscopes — Medical endoscopes and endotherapy devices — Part 1: General requirements

BS ISO 8600-6:2005

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