SIST EN ISO 10343:2014 PDF

Ophthalmic instruments - Ophthalmometers (ISO 10343:2014)

Название (английский):

SIST EN ISO 10343:2014

Ophthalmic instruments - Ophthalmometers (ISO 10343:2014)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 14
Дата публикации:: 5 сентября 2014 г.
ICS:: 11.040.70
Технический комитет:: VAZ - Healthcare

Тип поставки:

Full version210 €Read online 24h10 €Read online 72h15 €

Язык документа:

ruen

Срок поставки:3 раб. дн. (перевод)

Цена:210 €

Описание (английский):

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.

Технические детали

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

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

Технические детали

Abstract

Overview

Key topics and technical requirements

Похожие стандарты

Abstract

Overview

Key topics and technical requirements

Похожие стандарты

Ophthalmic instruments — Ophthalmometers

Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable…

Method to calculate GHG emissions at LNG plant (ISO 6338:2023)

Additive manufacturing of metals - Powder bed fusion (PBF) - In-situ coaxial photodiode monitoring for lack o…

Facility management - Development of the facility management organization (ISO 41002:2026)

Rigid cellular plastics - Determination of compressive properties (ISO 844:2026)

Processing of health care products - Information to be provided by the medical device manufacturer for the pr…

Ophthalmic optics - Uncut finished spectacle lenses - Part 4: Specifications and test methods for the propert…