19/30378395 DC - BS EN ISO 19980. Ophthalmic instruments. Corneal topographers

19/30378395 DC

BS EN ISO 19980. Ophthalmic instruments. Corneal topographers

Status : Current, Draft for public comment   Published : September 2019



This document specifies minimum requirements for instruments and systems that fall into the class of corneal topographers (CTs). It also specifies tests and procedures to verify that a system or instrument complies with this document and thus qualifies as a CT according to this document. It also specifies tests and procedures that allow the verification of capabilities of systems that are beyond the minimum requirements for CTs.

This document defines terms that are specific to the characterization of the corneal shape so that they may be standardized throughout the field of vision care.

This document is applicable to instruments, systems and methods that are intended to measure the surface shape of the cornea of the human eye.


The measurements can be of the curvature of the surface in local areas, three-dimensional topographical measurements of the surface or other more global parameters used to characterize the surface.

This document is not applicable to ophthalmic instruments classified as ophthalmometers.

Standard Number19/30378395 DC
TitleBS EN ISO 19980. Ophthalmic instruments. Corneal topographers
StatusCurrent, Draft for public comment
Publication Date24 September 2019
Normative References(Required to achieve compliance to this standard)IEC 60601-1:2005, IEC 60601-1:2005/AMD1:2012
Informative References(Provided for Information)IEC 61966-2-1, ISO 8429, ISO 10110-12, ISO 15004-1
International RelationshipsISO/DIS 19980
Draft Expiry Date12 November 2019
DescriptorsClinical investigation instruments, Ophthalmic equipment, Optical measurement, Verification, Eyes, Ophthalmic test equipment, Ophthalmology, Optical instruments
Title in FrenchInstruments ophtalmiques — Topographes de la cornée
File Size531 KB
NotesWarning: this draft is not current beyond its expiry date for comments.

 Your basket
Your basket is empty

Multi-user access to over 3,500 medical device standards, regulations, expert commentaries and other documents

Worldwide Standards
We can source any standard from anywhere in the world

Develop a PAS

Develop a fast-track standardization document in 9-12 months


The faster, easier way to work with standards