SIST EN ISO 10940:2009 PDF

Ophthalmic instruments - Fundus cameras (ISO 10940:2009)

Название (английский):

SIST EN ISO 10940:2009

Ophthalmic instruments - Fundus cameras (ISO 10940:2009)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 19
Дата публикации:: 10 сентября 2009 г.
ICS:: 11.040.70
Технический комитет:: VAZ - Healthcare

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Описание (английский):

ISO 10940:2009, together with ISO 15004-1 and ISO 15004-2, 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 the image information for diagnosis. ISO 10940:2009 takes precedence over ISO 15004-1 and ISO 15004-2, if differences exist.

Технические детали

SKU: SIST EN ISO 10940:2009

Abstract

Overview

EN ISO 10940:2009 - Ophthalmic instruments: Fundus cameras (ISO 10940:2009) specifies performance, construction and test-method requirements for fundus cameras used to observe, photograph or record electronic images of the human ocular fundus for diagnostic purposes. The standard applies together with ISO 15004‑1 and ISO 15004‑2 and takes precedence if requirements conflict. It excludes instruments that contact the eye or use scanning laser sources.

Key topics and technical requirements

Optical performance
- Quantified resolving power requirements on the fundus (e.g., higher lp/mm at centre, reduced values toward the periphery; different limits for angular field ≤30° and >30°).
- Near‑infrared (NIR) imaging: resolving power limits must be reduced by a factor of 1.6.
- Pixel pitch and image magnification tolerances are specified for digital and film recording systems.
- Angular field of view tolerance (±5% specified in the standard).
Mechanical and ergonomic requirements
- Instrument design must minimize reflections and stray light.
- High‑eye‑point eyepieces require a minimum clearance (≥17 mm) to allow spectacle wearers.
- Dioptre and focus adjustment ranges are specified to accommodate operator and patient refractive variations.
Optical radiation (light) safety
- Fundus cameras are classified per ISO 15004‑2 as Group 1 or Group 2; different emission limits, test methods and combined‑source rules apply.
- For Group 2 devices, additional limits and cumulative exposure rules (e.g., sum of ratios for pulsed and continuous sources within 8 h

Overview

Key topics and technical requirements

Optical performance
- Quantified resolving power requirements on the fundus (e.g., higher lp/mm at centre, reduced values toward the periphery; different limits for angular field ≤30° and >30°).
- Near‑infrared (NIR) imaging: resolving power limits must be reduced by a factor of 1.6.
- Pixel pitch and image magnification tolerances are specified for digital and film recording systems.
- Angular field of view tolerance (±5% specified in the standard).
Mechanical and ergonomic requirements
- Instrument design must minimize reflections and stray light.
- High‑eye‑point eyepieces require a minimum clearance (≥17 mm) to allow spectacle wearers.
- Dioptre and focus adjustment ranges are specified to accommodate operator and patient refractive variations.
Optical radiation (light) safety
- Fundus cameras are classified per ISO 15004‑2 as Group 1 or Group 2; different emission limits, test methods and combined‑source rules apply.
- For Group 2 devices, additional limits and cumulative exposure rules (e.g., sum of ratios for pulsed and continuous sources within 8 h

SIST EN ISO 10940:2009 PDF

Технические детали

Abstract

Overview

Key topics and technical requirements

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Abstract

Overview

Key topics and technical requirements

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