ISO 10940-2009 PDF

Full title and description

ISO 10940:2009 — Ophthalmic instruments — Fundus cameras. This International Standard specifies requirements and test methods for fundus cameras used to observe, photograph or record electronic images of the fundus (the interior surface of the eye) to provide image information for diagnosis.

Abstract

ISO 10940:2009 (Edition 2) defines performance, safety and test-method requirements for non-contact fundus cameras intended to produce diagnostic images of the retina. Where differences exist between ISO 10940:2009 and the related ISO 15004 series, ISO 10940:2009 takes precedence.

General information

• Status: Published (confirmed current following ISO systematic review process).
• Publication date: 2009-08 (Edition 2, 2009).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.70 (Ophthalmic equipment).
• Edition / version: Edition 2 (2009).
• Number of pages: 12 (official ISO edition page count).

Key bibliographic and lifecycle details are recorded on ISO's catalogue; the 2009 edition replaced ISO 10940:1998 and the 2009 edition was most recently confirmed by ISO's review process in 2024.

Scope

Specifies requirements and test methods for fundus cameras operating for observing, photographing or recording electronic images of the fundus of the human eye, in order to provide image information for diagnosis. The standard does not apply to certain types of instruments (for example, instruments that contact the eye and scanning laser devices) and takes precedence over ISO 15004‑1 and ISO 15004‑2 where differences occur.

Key topics and requirements

• Performance requirements for image capture (resolution, field of view and image fidelity).
• Test methods for assessing optical and imaging performance.
• Illumination characteristics and exposure control appropriate for retinal imaging.
• Safety and compatibility considerations specific to ophthalmic imaging equipment.
• Marking, instructions and information supplied for safe and effective clinical use.
• Exclusions and interfaces with related standards (notably ISO 15004 series); precedence rules where requirements differ.

Typical use and users

Used by ophthalmic device manufacturers (design and compliance teams), regulatory and conformity-assessment bodies, clinical engineers, hospital procurement teams and eye-care professionals responsible for selecting, operating or maintaining fundus cameras for diagnostic imaging. The standard supports product design, type testing, documentation and clinical-device risk assessment.

Related standards

ISO 15004-1 and ISO 15004-2 (ophthalmic instruments — specific safety and test considerations for ophthalmic equipment) are directly related and referenced; ISO 10940:1998 is the withdrawn predecessor to the 2009 edition. Regional/adopted versions exist (for example EN ISO adoptions).

Keywords

fundus camera, ophthalmic instruments, retinal imaging, diagnostic imaging, image quality, test methods, ISO 10940, ocular photography.

FAQ

Q: What is this standard?

A: ISO 10940:2009 is an International Standard that specifies requirements and test methods for fundus cameras used to capture diagnostic images of the eye's fundus (retina).

Q: What does it cover?

A: It covers performance and test-method requirements, illumination and imaging characteristics, marking and information to be supplied, and interfaces with related ophthalmic standards; it excludes certain device types such as instruments that contact the eye and scanning laser systems.

Q: Who typically uses it?

A: Device manufacturers, test laboratories, regulatory assessors, clinical engineers and eye-care providers involved in procurement, testing and safe use of fundus cameras.

Q: Is it current or superseded?

A: The 2009 (Edition 2) version replaced ISO 10940:1998 and, according to ISO's review records, the 2009 edition has been confirmed as current following periodic reviews (most recently confirmed in 2024).

Q: Is it part of a series?

A: It is related to the ISO 15004 series (which addresses safety and testing of ophthalmic instruments). Where differences exist between ISO 10940:2009 and ISO 15004‑1/‑2, ISO 10940 takes precedence for fundus-camera–specific requirements.

Q: What are the key keywords?

A: Fundus camera, ophthalmic instruments, retinal/ocular imaging, image quality, test methods, diagnostic imaging.