EN ISO 15253:2021 PDF

Name: EN ISO 15253:2021 — Ophthalmic optics and instruments - Optical and electro-optical devices for enhancing low vision (ISO 15253:2021)
SKU: EN ISO 15253:2021
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Ophthalmic optics and instruments - Optical and electro-optical devices for enhancing low vision (ISO 15253:2021)

Название (английский):

EN ISO 15253:2021

Ophthalmic optics and instruments - Optical and electro-optical devices for enhancing low vision (ISO 15253:2021)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 35
Дата публикации:: 14 июля 2021 г.
Издание:: CEN EN 15253 edition 2 version 1
ICS:: 11.040.70

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Описание (английский):

This document is applicable to optical and electro-optical devices specified by the manufacturer for use by visually impaired persons as low vision aids. This document specifies requirements and test methods for optical and electro-optical devices specified by the manufacturer for use by visually impaired persons as low vision devices. Implantable low vision devices are excluded.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 15253:2021 - "Ophthalmic optics and instruments - Optical and electro‑optical devices for enhancing low vision" - is the 2021 CEN-adopted version of ISO 15253. It sets out requirements and test methods for optical and electro‑optical low vision devices specified by the manufacturer for use by visually impaired persons. Implantable low vision devices are explicitly excluded. The standard merges and updates earlier ISO documents to provide a single, harmonized reference for designers, manufacturers, test laboratories and regulators.

Key topics and technical requirements

The standard covers classification, performance requirements and standardized test methods for low vision aids, including:

Classification

Optical devices: distance, near/intermediate, or devices intended to alter retinal illumination/contrast.
Electro‑optical devices: electronic magnifiers and similar systems.

General requirements

Risk assessment and risk management
Materials, dimensions and weight
Flammability/ignitability, resistance to perspiration
Robustness and drop resistance

Optical device requirements

Spatial resolution
Equivalent power (for near/intermediate magnifiers)
Magnification and lateral variation of magnification
Exit image distance (stand magnifiers)
Entrance pupil diameter (telescopes)
Transmittance and image relocation
Filters and tints for light sensitivity or contrast enhancement

Electro‑optical device requirements

Display size and magnification characteristics
Ambient temperature operating range
Image characteristics and uniformity of magnification
Object (X–Y) table and working distance
Text‑to‑speech functionality and electrical safety

Test methods

Spatial resolution tests, magnification (angular/transverse), exit image distance, display magnification and uniformity, plus procedures for lateral variation of magnification.

Manufacturer information

Marking, instructions for use and performance information required for end users and clinicians.

Applications and who uses this standard

EN ISO 15253:2021 is intended for practical use by:

Manufacturers and product designers of low vision aids to specify design, safety and performance.

Testing laboratories to verify conformance using harmonized test methods.

Clinicians, low vision specialists and occupational therapists seeking standardized performance data for device selection and fitting.

Procurement and regulatory bodies evaluating compliance and safety for market access.

Assistive technology developers integrating optical/electronic components (e.g., magnifiers with text‑to‑speech).

Practical use cases include product development, conformity assessment, clinical device selection and comparative product specifications for procurement.

Related standards

This edition supersedes earlier EN ISO 15253:2000 and EN ISO 15254:2009; it merges ISO 15253 and ISO 15254 requirements.

It is published under the ISO/CEN Vienna Agreement and adopted by CEN as EN ISO 15253:2021.

Keywords: EN ISO 15253:2021, low vision devices, optical and electro‑optical devices, ophthalmic optics, low vision aids, test methods, magnification, spatial resolution, text-to-speech.

EN ISO 15253:2021 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and who uses this standard

Related standards

Технические детали

ISO 15253:2021

Ophthalmic optics and instruments — Optical and electro-optical devices for enhancing low vision

ISO 15253:2000

Ophthalmic optics and instruments — Optical devices for enhancing low vision

ISO 15254:2009

Ophthalmic optics and instruments — Electro-optical devices for enhancing low vision

BS EN ISO 15253:2021

Ophthalmic optics and instruments. Optical and electro-optical devices for enhancing low vision.

ISO 15254:2002

Ophthalmic optics and instruments — Electro-optical devices for enhancing low vision