EN ISO 19980:2021 PDF

Overview

EN ISO 19980:2021 (ISO 19980:2021)-titled Ophthalmic instruments - Corneal topographers-defines minimum requirements, tests and procedures for instruments and systems that measure the surface shape of the human cornea. This European adoption of the ISO standard supersedes EN ISO 19980:2012 and standardizes terminology, performance reporting and verification methods for devices commonly called corneal topographers or videokeratographs.

Key topics and technical requirements

• Scope and definitions: Standardizes terms specific to corneal shape characterization (e.g., corneal apex, corneal meridian, eccentricity, conic descriptors).
• Minimum measurement requirements:
  • Area measured and measurement sample density expectations.
  • Requirements for measurement and report of performance, including standardized colour presentation of results.
• Test methods:
  • Accuracy test and repeatability test procedures to verify compliance.
  • Test surfaces and verification methods for different CT technologies:
    • Placido ring / reflection-based systems
    • Luminous surface topographers
    • Optical-sectioning topographers
  • Data collection, paired-data analysis and area-weighting calculations for accuracy reporting.
• Accompanying documentation and marking: Guidance on labelling and documentation to accompany CT devices.
• Annexes: Informative and normative annexes provide test surface examples, standardized display conventions, calculation methods and test methods for measuring human corneas (Annexes A–D).

Practical applications

• Device manufacturers: design validation, type testing, production quality control and documentation for regulatory submissions.
• Test laboratories and clinical engineers: perform accuracy and repeatability verification using defined test surfaces and data-analysis methods.
• Clinicians and researchers: interpret and compare corneal topography outputs using standardized terminology and display conventions.
• Regulatory bodies and procurement teams: assess conformity to harmonized performance criteria for ophthalmic instruments.

Who should use this standard

• Ophthalmic equipment manufacturers (corneal topographers / videokeratographs)
• Clinical and diagnostic labs, ophthalmic clinics and hospitals
• Test houses, conformity assessment bodies and device regulators
• R&D teams developing corneal imaging and measurement systems

Related standards

• IEC 60601-1 (medical electrical equipment - basic safety and essential performance) - normative reference cited in EN ISO 19980:2021
• ISO 8429 and ISO 10110-12 (terminology and conic descriptors referenced in the standard)

Keywords: EN ISO 19980:2021, ISO 19980:2021, corneal topographers, corneal topography, ophthalmic instruments, Placido ring, optical-sectioning, accuracy test, repeatability test, corneal measurement.