ISO 10342-2010 PDF

Full title and description

ISO 10342:2010 — Ophthalmic instruments — Eye refractometers. This International Standard (edition 3, 2010) specifies requirements and test methods for eye refractometers that use an objective measuring principle; it is commonly distributed in PDF and print formats for manufacturers, test laboratories and regulators.

Abstract

ISO 10342:2010, used together with ISO 15004‑1, specifies requirements and test methods for eye refractometers using an objective measuring principle and is limited to the measurement of spherocylindrical refractive error. Where differences exist, ISO 10342:2010 takes precedence over ISO 15004‑1.

General information

• Status: Published (confirmed as current in ISO systematic reviews).
• Publication date: 2010-06 (June 2010).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.70 (Ophthalmic instruments).
• Edition / version: Edition 3 (2010).
• Number of pages: 6 pages (ISO published version).

These bibliographic details are taken from the ISO record for ISO 10342:2010. The ISO entry also shows this edition was reviewed and confirmed in subsequent reviews, indicating it remained the current edition at the time of the last confirmations.

Scope

ISO 10342:2010 applies to eye refractometers that use an objective measuring principle and is limited specifically to measurement of spherocylindrical refractive error. It is intended to be used together with the general ophthalmic instrument requirements in ISO 15004‑1; where the two documents differ, ISO 10342:2010 takes precedence.

Key topics and requirements

• Requirements and test methods for objective eye refractometers: definitions, measurement principles and test procedures.
• Measurement scope limited to spherocylindrical refractive error (sphere, cylinder and axis components).
• Relationship to ISO 15004‑1 (general ophthalmic instrument requirements) and precedence rules when differences occur.
• Performance-related expectations such as accuracy, repeatability and appropriate test conditions (typical contents for standards of this type; specific clauses found in the full text).
• Normative references and test methods for verifying instrument performance; marking and documentation expected for manufacturers.

Typical use and users

Primary users include manufacturers and designers of objective eye refractometers, calibration and test laboratories, conformity assessment bodies, regulatory reviewers and, where relevant, clinical engineering groups involved in device evaluation and procurement. The standard is used to design tests, write product specifications and demonstrate compliance with internationally accepted measurement practices.

Related standards

Key related documents include ISO 15004‑1 (Fundamental requirements and test methods — general requirements applicable to ophthalmic instruments) and other parts of the ISO 15004 series that address light-hazard protection and general ophthalmic instrument requirements. National or regional adoptions (for example EN ISO or DIN/UNE adoptions) may exist that incorporate ISO 10342:2010 with national forewords or annexes.

Keywords

eye refractometer; ophthalmic instrument; objective measurement; spherocylindrical refractive error; test methods; ISO 10342; ISO/TC 172/SC 7.

FAQ

Q: What is this standard?

A: ISO 10342:2010 is an International Standard titled "Ophthalmic instruments — Eye refractometers" that sets out requirements and test methods for objective eye refractometers (edition 3, 2010).

Q: What does it cover?

A: It covers requirements and test methods for eye refractometers using an objective measuring principle, limited to measurement of spherocylindrical refractive error; it is intended to be used alongside ISO 15004‑1.

Q: Who typically uses it?

A: Manufacturers of refractometers, test and calibration laboratories, conformity assessment and regulatory bodies, and clinical/biomedical engineers are the primary users.

Q: Is it current or superseded?

A: ISO 10342:2010 is the revised edition that replaced earlier editions (1997, 2003). The ISO record shows the 2010 edition was subject to systematic reviews and confirmations (for example confirmation actions in later review cycles), indicating it has been maintained as the extant edition through ISO review cycles. Users should check the ISO catalogue or their national standards body for the very latest status before relying on the standard for regulatory submissions.

Q: Is it part of a series?

A: It is part of the ISO ophthalmic instruments family and is intended to be used with the ISO 15004 series (general requirements and light-hazard protection) and other related ophthalmic instrument standards developed by ISO/TC 172/SC 7.

Q: What are the key keywords?

A: Eye refractometer, ophthalmic instruments, objective measurement, spherocylindrical refractive error, test methods, ISO 10342.