ISO 8600-3:2019

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.