What is ISO 19980 about?
ISO 19980 is one of a series of documents for ophthalmic instruments that 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 ISO 19980. It also specifies tests and procedures that allow the verification of capabilities of systems that are beyond the minimum requirements for CTs.
ISO 19980 defines terms that are specific to the characterization of the corneal shape so that they may be standardized throughout the field of vision care. It is applicable to instruments, systems, and methods that are intended to measure the surface shape of the cornea of the human eye.
NOTE: 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. And is not applicable to ophthalmic instruments classified as ophthalmometers.
Who is ISO 19980 for?
ISO 19980 is applicable to-
- Manufacturers of Corneal topographers
- Ophthalmologist
- Technical staff for corneal topographer
- Research centres
- Healthcare facilities
Why should you use ISO 19980?
The corneal topographer produces a detailed, visual description of the shape and power of the cornea. This type of analysis help ophthalmologist with very fine details regarding the condition of the corneal surface.
ISO 19980 provides manufacturers and operators of Corneal topographers with minimum requirements that fall into class. It also provides tests and procedures that help them ensure Corneal topographers are measuring the surface shape of the cornea of the human eye properly and safely. ISO 19980 also ensures that expected quality standards are achieved and no harm throughout the life cycle of Corneal topographers as Ophthalmic instruments has occurred.
What’s changed since the last update?
BS EN ISO 19980:2021 supersedes ISO 19980:2012, which has been withdrawn. BS EN ISO 19980:2021 has some significant technical changes with respect to ISO 19980:2012, these include:
- Normative references were updated
- 2.6 regarding requirements for test surfaces and requirement for testing of accuracy was changed
- In 4.3, formulae for data analysis have been updated
- Table 4 was deleted
- Document editorially revised