SIST EN ISO 10343:2014 PDF

Ophthalmic instruments - Ophthalmometers (ISO 10343:2014)

Title (English):

SIST EN ISO 10343:2014

Ophthalmic instruments - Ophthalmometers (ISO 10343:2014)

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 14
Publication date:: September 5, 2014
ICS:: 11.040.70
Technical committee:: VAZ - Healthcare

Document language:

enru

Delivery time:1–7 days

Price:60 €

Description (English):

ISO 10343:2009, together with ISO 15004-1, specifies requirements and test methods for continuously or digitally indicating ophthalmometers. Certain types of ophthalmometer are capable of measuring radii of curvature of contact lenses as described in ISO 18369-3:2006, 4.1. It is assumed that the local corneal front surface and both contact lens surfaces are spherical or toroidal. ISO 10343:2009 takes priority over ISO 15004-1, if differences exist.

Technical details

SKU: SIST EN ISO 10343:2014

Abstract

Overview

EN ISO 10343:2014 - Ophthalmic instruments - Ophthalmometers is the CEN-adopted version of ISO 10343:2014. It specifies requirements and type-test methods for continuously or digitally indicating ophthalmometers used to measure the radii of curvature and principal meridians of the cornea and, for higher-resolution instruments, contact lenses. The standard assumes local corneal and contact-lens surfaces are spherical or toroidal and takes precedence over ISO 15004-1 where conflicts exist.

Key topics and technical requirements

Measurement range: instruments must cover 6.5 mm to 9.4 mm (approx. 52.0 KD to 36.0 KD).
Instrument types:
- Type A - higher resolution suitable for contact lenses and corneas: continuous scale interval 0.02 mm, digital increment 0.02 mm, measurement accuracy ±0.025 mm (2σ).
- Type B - for human corneas: continuous scale interval 0.1 mm, digital increment 0.02 mm, measurement accuracy ±0.05 mm (2σ).
Meridian (axis) measurement: angular range 0°–180°; continuous scale interval 5°, digital increment 1°. Accuracy depends on meridional curvature difference: ±4° (≤0.3 mm) and ±2° (>0.3 mm).
Eyepiece adjustment: distance-dependent instruments must have dioptric adjustment at least −4 D to +4 D, with −3 D to +2 D calibrated.
Test methods and type testing: conformity is verified using precise spherical/toroidal test surfaces and test devices with tight surface tolerances (e.g., sphere uncertainty ≤1 µm). Measuring devices used for verification must have errors

Related standards

Mentioned in the description and other SIST standards

Overview

Key topics and technical requirements

Measurement range: instruments must cover 6.5 mm to 9.4 mm (approx. 52.0 KD to 36.0 KD).
Instrument types:
- Type A - higher resolution suitable for contact lenses and corneas: continuous scale interval 0.02 mm, digital increment 0.02 mm, measurement accuracy ±0.025 mm (2σ).
- Type B - for human corneas: continuous scale interval 0.1 mm, digital increment 0.02 mm, measurement accuracy ±0.05 mm (2σ).
Meridian (axis) measurement: angular range 0°–180°; continuous scale interval 5°, digital increment 1°. Accuracy depends on meridional curvature difference: ±4° (≤0.3 mm) and ±2° (>0.3 mm).
Eyepiece adjustment: distance-dependent instruments must have dioptric adjustment at least −4 D to +4 D, with −3 D to +2 D calibrated.
Test methods and type testing: conformity is verified using precise spherical/toroidal test surfaces and test devices with tight surface tolerances (e.g., sphere uncertainty ≤1 µm). Measuring devices used for verification must have errors

SIST EN ISO 10343:2014 PDF

Technical details

Abstract

Overview

Key topics and technical requirements

Related standards

Abstract

Overview

Key topics and technical requirements

Related standards

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