EN ISO 10939:2017 PDF

Name: EN ISO 10939:2017 — Ophthalmic instruments - Slit-lamp microscopes (ISO 10939:2017)
SKU: EN ISO 10939:2017
Price: 60.09 EUR
Availability: InStock

Ophthalmic instruments - Slit-lamp microscopes (ISO 10939:2017)

Название (английский):

EN ISO 10939:2017

Ophthalmic instruments - Slit-lamp microscopes (ISO 10939:2017)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 13
Дата публикации:: 7 июня 2017 г.
Издание:: CEN EN 10939 edition 2 version 1
ICS:: 11.040.70

Тип поставки:

Full version195 €Read online 24h10 €Read online 72h15 €

Язык документа:

ruen

Срок поставки:3 раб. дн. (перевод)

Цена:195 €

Описание (английский):

ISO 10939:2017, together with ISO 15004‑1 and ISO 15004‑2, specifies requirements and test methods for slit-lamp microscopes to provide slit illumination and observation under magnification of the eye and its adnexa. ISO 10939:2017 is not applicable to microscope accessories, e.g. photographic equipment and lasers. ISO 10939:2017 takes precedence over ISO 15004‑1 and ISO 15004‑2, if differences exist.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 10939:2017 - Ophthalmic instruments: Slit‑lamp microscopes specifies requirements and test methods for slit‑lamp microscopes used to provide slit illumination and magnified observation of the eye and adnexa. Published by CEN/ISO, this standard is intended for the design, testing and conformity assessment of slit‑lamp microscopes (excluding accessories such as photographic equipment and lasers). Where differences exist, EN ISO 10939:2017 takes precedence over ISO 15004‑1 and ISO 15004‑2.

Key topics and technical requirements

Scope and precedence: Applies together with ISO 15004‑1 (general ophthalmic instrument requirements) and ISO 15004‑2 (light hazard protection); EN ISO 10939:2017 overrides those where conflicts exist.

Optical requirements (Table 1): includes numerical tolerances such as:

Magnification tolerance: ±5%
Left/right magnification difference: ≤3%
Interpupillary adjustment range: 55 mm to 72 mm
Slit image: minimum width 0.2 mm, minimum length 8.0 mm, with strict parallelism and shape criteria
Focus and alignment tolerances: axial and lateral focus tolerances (e.g., axial Δa ≈ ±0.5 mm; lateral ≈ ±0.35 mm), and permissible shift in object plane ≤0.4 mm
Dioptre scale calibration error: ±0.25 D at zero; typical adjustment ranges (e.g., −5.00 D to +5.00 D; −4.00 D to +2.00 D for high‑eye‑point eyepieces)
Exit pupil difference between left and right systems: ≤1.5 mm

High eye point eyepiece: if claimed, exit pupil clearance must be ≥17 mm to allow spectacles.

Construction and performance: requirements for slit edge quality, even illumination, absence of stray light/contrast loss, and minimum resolving power at high magnification.

Optical radiation / light hazard: classification into Group 1 or Group 2 per ISO 15004‑2 with specific test methods and exposure limits; additional measures required if used with supplementary lenses (e.g., 90 D Volk lens).

Test and measurement rules: type testing; measurement devices must have errors smaller than 10% of the smallest value to be determined; results evaluated statistically.

Applications and users

Medical device manufacturers designing and producing slit‑lamp microscopes for ophthalmology.

Test laboratories and conformity assessment bodies performing type testing and verification to EN ISO 10939:2017.

Regulatory and procurement specialists ensuring devices meet optical safety and performance criteria.

Clinical engineers and optometrists/ophthalmologists involved in device selection, maintenance and safety checks.

Related standards

ISO 15004‑1 - Fundamental requirements and test methods (general ophthalmic instruments)

ISO 15004‑2 - Light hazard protection for ophthalmic instruments

IEC 60601‑1:2005 + AMD1:2012 - referenced for medical electrical equipment safety where applicable

Keywords: EN ISO 10939:2017, slit‑lamp microscopes, ophthalmic instruments, optical requirements, light hazard protection, ISO 15004‑2, high eye point eyepiece, dioptre calibration.

EN ISO 10939:2017 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and users

Related standards

Технические детали

ISO 10939:2017

Ophthalmic instruments — Slit-lamp microscopes

IEC 60601-1:2005

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

SIST EN ISO 15004-1:2021

Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable…

SIST EN ISO 15004-2:2025

Ophthalmic instruments - Fundamental requirements and test methods - Part 2: Light hazard protection (ISO 150…