ISO 10343-2014 PDF

Full title and description

ISO 10343:2014 — Ophthalmic instruments — Ophthalmometers. This International Standard specifies requirements and test methods for continuously or digitally indicating ophthalmometers and is available in PDF and paper formats from ISO.

Abstract

Specifies performance requirements and test methods for ophthalmometers (keratometers) that provide continuous or digital indication. The standard covers instruments with sufficient resolution and range to measure corneal curvature and, for some instruments, the radii of curvature of contact lenses; it assumes the measured surfaces are locally spherical or toroidal.

General information

• Status: Published (confirmed current after periodic review in 2024).
• Publication date: 2014-07 (Edition 3, published June–July 2014).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.70 (ophthalmic instruments).
• Edition / version: Edition 3 (2014).
• Number of pages: 7 (ISO bibliographic record).

Facts above are taken from the ISO bibliographic record for ISO 10343:2014.

Scope

ISO 10343:2014 applies to continuously or digitally indicating ophthalmometers and establishes the requirements and test methods necessary to evaluate their performance. It includes provisions for instruments capable of measuring corneal curvature and, where resolution and range permit, the radii of curvature of contact lenses; measurements assume locally spherical or toroidal surfaces.

Key topics and requirements

• Performance criteria for continuously and digitally indicating ophthalmometers (accuracy, resolution and repeatability).
• Specified test methods to verify instrument performance under defined conditions.
• Guidance on instruments' ability to measure corneal curvature and, when appropriate, contact lens curvature (subject to resolution/range limits).
• Assumptions about surface form for measurement (local spherical or toroidal models).
• Conformity and verification steps for manufacturers and test laboratories.

Key requirements and scope elements are summarized from the ISO standard abstract and bibliographic information.

Typical use and users

Manufacturers of ophthalmic instruments (ophthalmometers/keratometers), ophthalmic test laboratories, contact lens manufacturers and quality departments, clinical optical/ophthalmic practices, and conformity assessment bodies use this standard to design, test and validate ophthalmometer performance and to ensure consistent measurement of corneal and (where applicable) contact-lens curvature.

Related standards

ISO 10343 is developed by ISO/TC 172/SC 7 (ophthalmic instruments) and is related to other ophthalmic standards; earlier editions and related references have linked ISO 10343 with ISO 15004-1 and with contact-lens standards such as ISO 18369‑3. Users should review referenced ISO documents when applying ISO 10343 in contact-lens measurement contexts.

Keywords

ophthalmometer, keratometer, keratometry, corneal curvature, contact lens curvature, ophthalmic instruments, test methods, accuracy, ISO 10343

FAQ

Q: What is this standard?

A: ISO 10343:2014 is an International Standard titled "Ophthalmic instruments — Ophthalmometers" that specifies requirements and test methods for continuously or digitally indicating ophthalmometers.

Q: What does it cover?

A: It covers performance requirements and test methods for ophthalmometers (including instruments capable—when suitably specified—of measuring contact-lens curvature), and assumes measured surfaces are locally spherical or toroidal.

Q: Who typically uses it?

A: Instrument manufacturers, test and calibration laboratories, contact lens producers, clinical optics/ophthalmic practitioners, and conformity assessment bodies use it for design validation, testing, quality control and to support regulatory/compliance activities.

Q: Is it current or superseded?

A: The 2014 edition (Edition 3) is published and was last reviewed and confirmed by ISO in 2024, so the 2014 version is current.

Q: Is it part of a series?

A: It is part of the ophthalmic instruments work of ISO/TC 172/SC 7 and is related to other ophthalmic standards (for example, documents dealing with ophthalmic instruments and contact lenses such as ISO 15004‑1 and ISO 18369 series). Users should consult related ISO documents for complete context.

Q: What are the key keywords?

A: Ophthalmometer, keratometer, corneal curvature, contact lens curvature, ophthalmic instruments, test methods, accuracy, ISO 10343.