SIST EN ISO 15253:2021 PDF

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.