ISO 10343-2014 pdf free.Ophthalmic instruments – Ophthalmometers.
ISO 10343, together with ISO 15004-I, specifies requirements and test methods for continuously or digitally indicating ophthalmometers. Certain types of ophthalmometer have sufficient resolution and range (see Table 2) to adequately measure the radii of curvature of contact lenses complying with ISO 18369-3:2006, 4.1.3, and Clause 5. It is assumed that the local corneal front surface and both contact lens surfaces are spherical or toroidal.
This International Standard takes priority over ISO 15004-1, if differences exist.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 8429, Optics and optical instruments — Ophthalmology — Graduated dial scale
ISO 15004-1:2006. Ophthalmic instruments — Fundamental requirements and test methods — Part 1:
General requirements applicable to all ophthalmic instruments
IEC 60601-1, Medical electrical equipment — Part 1: General requirements for basic safety and essential
performance
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1 ophthalmometer
instrument designed to measure and indicate the radii of curvature and principal meridians of the human cornea’s central area and of contact lenses
3.2 distance-dependent ophthalmometer
ophthalmometer in which the result of measurement is influenced by the distance between the instrument and the surface to be measured
3.3 toroidal surface
surface having two orthogonal, circular principal meridians, one maximum and one minimum, and generated by a circular arc rotating about an axis which is in the same plane as the arc but which does not pass through its centre of curvature.
4 Requirements
4.1 General
The ophthalmometer shall conform to the requirements specified in Iso 15004-1.
4.2 Radius of curvature measurements
The ophthalmometer shall conform to requirements given in Table 1 or Table 2. Conformity shall be verified as described in 52. lithe instrument conforms to the requirement of TahIeJ. it is a Type B” ophthalmometer. If the instrument conforms to the requirements of Table2 it is a Type A ophthalmometer. Type A and Type B ophthalmometers have sufficient resolution and range to adequately measure human corneas. Type A ophthalmometers have sufficient resolution and range (see Table 2) to adequately measure the radii of curvature of contact lenses complying with ISO 18369-3:2006, 4.1.3. and Clause 5, It is assumed that the local corneal front surface and both contact lens surfaces are spherical or toroidal.ISO 10343 pdf download.