Overview
EN ISO 10342:2010 - Ophthalmic instruments - Eye refractometers (ISO 10342:2010) specifies requirements and type test methods for eye refractometers that use an objective measuring principle. The standard is limited to measurement of spherocylindrical refractive error (sphere, cylinder and axis). Where differences exist, ISO 10342:2010 takes precedence over ISO 15004‑1.
Key topics and technical requirements
- Scope: Objective eye refractometers for spherocylindrical error measurement; tests are type tests and results are evaluated statistically.
- Measuring ranges:
- Vertex (sphere) power: minimum −15 D to +15 D.
- Cylinder power: minimum 0 D to 6 D (if instrument indicates cylindrical power).
- Axis direction: 0° to 180°.
- Accuracy and tolerances (typical):
- Spherical vertex power: accuracy checks at −15, −10, −5, 0, +5, +10, +15 D; typical tolerance ±0.25 D at standard points; maximum meridional vertex may be ±0.50 D.
- Cylindrical vertex power: checked at 3 D; tolerance ±0.25 D.
- Cylinder axis: orientation accuracy within ±5°; digitally indicating instruments may provide 1° display steps while maintaining the axis tolerance.
- Operator eyepiece: dioptric adjustment range at least −4 D to +4 D (if applicable).
- Test device requirements (Annex A): optical glass with Abbe number 58–60; refractive power of test device known to ±0.06 D; test-device alignment to instrument axis within ±1°.
- Marking & documentation: mandatory manufacturer identification, model, reference to ISO 10342:2010 if claimed, reference wavelength, instructions for use, disinfection, transport conditions, and calibration-check procedures.
- Normative testing methods: use of a specified model eye/test device, measurement intervals, and procedures for verifying power and axis.
Applications and who uses this standard
EN ISO 10342:2010 is intended for:
- Manufacturers of objective eye refractometers (design, production and compliance testing).
- Test laboratories and conformity assessors performing type tests and device calibration.
- Ophthalmic clinics and optometry practices evaluating instrument performance and calibration.
- Regulatory bodies and procurement teams specifying performance and acceptance criteria for diagnostic ophthalmic instruments.
- Service and repair providers responsible for verification after maintenance.
Practical uses include device design verification, factory acceptance testing, routine calibration checks, and inclusion of compliance claims in technical documentation.
Related standards
- ISO 15004‑1 - general requirements for ophthalmic instruments (ISO 10342 takes precedence where differences exist)
- ISO 7944 - reference wavelengths
- ISO 8429 - axis notation/scale conventions
- ISO 13666 - ophthalmic optics vocabulary
- IEC 60601‑1 - medical electrical equipment basic safety and essential performance
Keywords: eye refractometer, ophthalmic instruments, spherocylindrical refractive error, objective refractometer, vertex power, cylinder axis, calibration, ISO 10342:2010.
