ISO 10341-2012 PDF

Full title and description

ISO 10341:2012 — Ophthalmic instruments — Refractor heads. This International Standard specifies requirements and test methods for refractor heads (phoropter heads) used for the determination of refractive errors and binocular functions of the human eye.

Abstract

ISO 10341:2012 defines performance, construction and test requirements for refractor heads to ensure reliable measurement of refractive status and binocular vision functions. It provides test procedures and acceptance criteria intended for manufacturers, test laboratories and conformity assessment bodies.

General information

• Status: Published (confirmed after periodic review; current edition).
• Publication date: 29 November 2012 (commonly listed as December 2012 in ISO bibliographic record).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.70 (Ophthalmic equipment).
• Edition / version: Edition 3 (2012).
• Number of pages: 8 pages (official ISO bibliographic listing).

Scope

This standard applies to refractor heads (assemblies used in refraction examinations, commonly mounted in phoropters or as table-mounted heads) and specifies the requirements and test methods necessary to determine optical and mechanical performance for reliable clinical use. It is intended to assist manufacturers in designing and testing refractor heads and to assist purchasers and testing bodies in assessing conformity.

Key topics and requirements

• Definitions and terminology relevant to refractor heads (phoropters) and their components.
• Performance requirements for optical elements and lens selection accuracy.
• Mechanical construction, mounting interfaces and ergonomic considerations for clinical use.
• Test methods and acceptance criteria for accuracy, repeatability and mechanical stability.
• Marking, documentation and information supplied by the manufacturer (identification, operating instructions, maintenance guidance).
• Requirements to support conformity assessment and routine verification/calibration procedures.

Typical use and users

Primary users include manufacturers of ophthalmic instruments and refractor heads, test laboratories performing type testing and conformity assessment, clinical equipment purchasers, ophthalmic clinics and optometry practices seeking to evaluate or procure phoropter heads, and regulatory organizations overseeing medical device conformity. The standard is also used by maintenance and calibration service providers.

Related standards

ISO 10341 is part of the suite of ophthalmic-instruments standards and is related to the ISO 15004 series (Fundamental requirements and test methods for ophthalmic instruments — Part 1: general requirements; Part 2: light-hazard protection) and other vertical standards for specific ophthalmic devices (for example standards for indirect ophthalmoscopes). These related documents provide more general safety/performance requirements or cover other classes of ophthalmic instruments.

Keywords

refractor head, phoropter, ophthalmic instruments, refractive error, binocular function, test methods, optical accuracy, ISO 10341, calibration, ophthalmic equipment

FAQ

Q: What is this standard?

A: ISO 10341:2012 is an International Standard that specifies requirements and test methods for refractor heads used in clinical refraction to determine refractive errors and binocular vision functions.

Q: What does it cover?

A: It covers performance, construction and test methods for refractor heads (phoropter heads), including optical and mechanical requirements, tests for accuracy and repeatability, and information the manufacturer should supply.

Q: Who typically uses it?

A: Manufacturers, conformity assessment bodies and test laboratories, clinical equipment purchasers, ophthalmic clinics and optometry practices, and calibration/maintenance providers.

Q: Is it current or superseded?

A: The 2012 edition (Edition 3) is the current published edition and was reviewed/confirmed in ISO's periodic review process; it remains the active edition (confirmed in ISO's review). Users should always check ISO or their national body for any amendments or newer revisions.

Q: Is it part of a series?

A: Yes — ISO 10341 sits within the body of ophthalmic-instruments standards developed by ISO/TC 172/SC 7 and is commonly used alongside the ISO 15004 series and other device-specific ophthalmic standards that together address fundamental requirements, safety and test methods for ophthalmic equipment.

Q: What are the key keywords?

A: refractor head, phoropter, ophthalmic instruments, refractive error, binocular function, test methods, calibration, optical accuracy.