ISO 12865:2006
(Main)Ophthalmic instruments - Retinoscopes
Ophthalmic instruments - Retinoscopes
ISO 12865:2006, together with ISO 15004-1, specifies minimum requirements and test methods for hand-held streak and spot retinoscopes for use in objective determination of the refractive errors of the eye. ISO 12865:2006 takes precedence over ISO 15004-1, if differences exist.
Instruments ophtalmiques — Skiascopes
L'ISO 12865:2006 spécifie, conjointement à l'ISO 15004-1, les exigences minimales et les méthodes d'essai relatives aux skiascopes portatifs à faisceau rectangulaire ou circulaire destinés à la détermination objective des anomalies de réfraction de l'oeil. L'ISO 12865:2006 a la priorité sur l'ISO 15004-1, si des différences existent.
General Information
- Status
- Published
- Publication Date
- 25-Jun-2006
- Technical Committee
- ISO/TC 172/SC 7 - Ophthalmic optics and instruments
- Drafting Committee
- ISO/TC 172/SC 7 - Ophthalmic optics and instruments
- Current Stage
- 9060 - Close of review
- Completion Date
- 04-Mar-2031
Relations
- Effective Date
- 15-Apr-2008
Overview
ISO 12865:2006 titled Ophthalmic Instruments - Retinoscopes is an international standard published by ISO that specifies the minimum requirements and testing methods for hand-held streak and spot retinoscopes. These ophthalmic instruments are essential for the objective determination of refractive errors of the eye. This second edition supersedes the first edition from 1998 and takes precedence over ISO 15004-1 when differences occur. The standard ensures consistency, safety, and functionality in the design and testing of portable retinoscopes used worldwide in ophthalmic diagnostics.
Key Topics
Scope and Application
ISO 12865:2006 applies to hand-held streak (slit) and spot retinoscopes used for objectively measuring eye refractive errors. It defines performance, construction, and optical requirements as well as test procedures.Definitions
- Skiascope (Retinoscope): An ophthalmic instrument that projects a light beam into the eye to observe the reflex from the retina, assessing refractive anomalies objectively.
- Skiascope à fente: Emits a rectangular light beam with adjustable focus and orientation.
- Skiascope à spot: Emits a circular light beam, possibly with adjustable focus.
Optical and Mechanical Requirements
The standard sets precise criteria such as:- Rotation angle of the light beam (minimum 190°)
- Adjustable real and virtual image distances (up to 450 mm and 1000 mm respectively)
- Dimensions of the rectangular light beam in streak retinoscopes (length ≥ 30 mm, width ≤ 1.5 mm)
- Diameter of the circular beam in spot retinoscopes (maximum 25 mm at 500 mm distance)
- Uniform illumination free from color irregularities or distortion
Construction and Functionality
Retinoscopes must avoid internal reflections and stray light during use. Light intensity adjustment from zero to maximum, either continuously or stepped, is mandatory. Additional requirements focus on the continuous rotation and focusing capabilities of streak retinoscopes and uniform, circular beam illumination for spot models.Testing Methods
The standard outlines type tests to verify compliance using precise measurement tools. Key tests include verifying beam focus distances and observing optical performance parameters according to the specified criteria.Marking and Documentation
Each device must bear indelible markings showing the manufacturer’s name, model designation, and electrical safety marks as per IEC 60601-1. Accompanying documents must include user instructions, manufacturer details, shipment certification, and declaration of conformity.
Applications
ISO 12865:2006 is highly relevant to manufacturers of ophthalmic diagnostic equipment, optical engineers, and healthcare providers specializing in eye care:
Clinical Eye Examinations
Retinoscopes adhering to this standard provide reliable and objective measurements of refractive errors-critical for prescribing corrective lenses or diagnosing eye health conditions.Quality Assurance for Medical Devices
Ensures retinoscopes meet international safety and performance benchmarks, facilitating global market access and regulatory compliance.Product Development and Testing
Acts as a guideline for designing portable retinoscopes with consistent optical quality, durability, and user safety.Training and Usage
Standardized illumination and focusing features support effective training of eye care professionals, improving diagnostic accuracy.
Related Standards
ISO 15004-1 – Ophthalmic Instruments – Fundamental Requirements and Test Methods – Part 1: General Requirements Applicable to All Ophthalmic Instruments
Provides overarching general requirements that complement ISO 12865:2006.IEC 60601-1:2005 – Medical Electrical Equipment – Part 1: General Requirements for Basic Safety and Essential Performance
Establishes electrical safety and essential performance requirements necessary for retinoscopes with electrical components.
Keywords: ISO 12865:2006, retinoscopes, ophthalmic instruments, eye refractive error measurement, hand-held streak retinoscopes, spot retinoscopes, optical requirements, medical device standards, eye care equipment, ISO ophthalmic standards.
Frequently Asked Questions
ISO 12865:2006 is a standard published by the International Organization for Standardization (ISO). Its full title is "Ophthalmic instruments - Retinoscopes". This standard covers: ISO 12865:2006, together with ISO 15004-1, specifies minimum requirements and test methods for hand-held streak and spot retinoscopes for use in objective determination of the refractive errors of the eye. ISO 12865:2006 takes precedence over ISO 15004-1, if differences exist.
ISO 12865:2006, together with ISO 15004-1, specifies minimum requirements and test methods for hand-held streak and spot retinoscopes for use in objective determination of the refractive errors of the eye. ISO 12865:2006 takes precedence over ISO 15004-1, if differences exist.
ISO 12865:2006 is classified under the following ICS (International Classification for Standards) categories: 11.040.70 - Ophthalmic equipment. The ICS classification helps identify the subject area and facilitates finding related standards.
ISO 12865:2006 has the following relationships with other standards: It is inter standard links to ISO 12865:1998. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
ISO 12865:2006 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 12865
Second edition
2006-07-01
Ophthalmic instruments — Retinoscopes
Instruments ophtalmiques — Skiascopes
Reference number
©
ISO 2006
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Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies
(ISO member bodies). The work of preparing International Standards is normally carried out through ISO
technical committees. Each member body interested in a subject for which a technical committee has been
established has the right to be represented on that committee. International organizations, governmental and
non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the
International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. ISO shall not be held responsible for identifying any or all such patent rights.
ISO 12865 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This second edition cancels and replaces the first edition (ISO 12865:1998), which has been technically
revised.
INTERNATIONAL STANDARD ISO 12865:2006(E)
Ophthalmic instruments — Retinoscopes
1 Scope
This International Standard, together with ISO 15004-1, specifies minimum requirements and test methods for
hand-held streak and spot retinoscopes for use in objective determination of the refractive errors of the eye.
This International Standard takes precedence over ISO 15004-1, if differences exist.
2 Normative references
The following referenced documents are indispensable for the application of this document. For dated
references, only the edition cited applies. For undated references, the latest edition of the referenced
document (including any amendments) applies.
ISO 15004-1, Ophthalmic instruments — Fundamental requirements and test methods — Part 1: General
requirements applicable to all ophthalmic instruments
IEC 60601-1:2005, Medical electrical equipment — Part 1: General requirements for basic safety and
essential performance
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
retinoscope
ophthalmic instrument designed to assess objectively refractive errors of the eye by reflecting a beam of light
into it from a mirror and obser
...
NORME ISO
INTERNATIONALE 12865
Deuxième édition
2006-07-01
Instruments ophtalmiques — Skiascopes
Ophthalmic instruments — Retinoscopes
Numéro de référence
©
ISO 2006
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Publié en Suisse
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Avant-propos
L'ISO (Organisation internationale de normalisation) est une fédération mondiale d'organismes nationaux de
normalisation (comités membres de l'ISO). L'élaboration des Normes internationales est en général confiée
aux comités techniques de l'ISO. Chaque comité membre intéressé par une étude a le droit de faire partie du
comité technique créé à cet effet. Les organisations internationales, gouvernementales et non
gouvernementales, en liaison avec l'ISO participent également aux travaux. L'ISO collabore étroitement avec
la Commission électrotechnique internationale (CEI) en ce qui concerne la normalisation électrotechnique.
Les Normes internationales sont rédigées conformément aux règles données dans les Directives ISO/CEI,
Partie 2.
La tâche principale des comités techniques est d'élaborer les Normes internationales. Les projets de Normes
internationales adoptés par les comités techniques sont soumis aux comités membres pour vote. Leur
publication comme Normes internationales requiert l'approbation de 75 % au moins des comités membres
votants.
L'attention est appelée sur le fait que certains des éléments du présent document peuvent faire l'objet de
droits de propriété intellectuelle ou de droits analogues. L'ISO ne saurait être tenue pour responsable de ne
pas avoir identifié de tels droits de propriété et averti de leur existence.
L'ISO 12865 a été élaborée par le comité technique ISO/TC 172, Optique et photonique, sous-comité SC 7,
Optique et instruments ophtalmiques.
Cette deuxième édition annule et remplace la première édition (ISO 12865:1998), qui a fait l'objet d'une
révision technique.
NORME INTERNATIONALE ISO 12865:2006(F)
Instruments ophtalmiques — Skiascopes
1 Domaine d'application
La présente Norme internationale spécifie, conjointement à l'ISO 15004-1, les exigences minimales et les
méthodes d'essai relatives aux skiascopes portatifs à faisceau rectangulaire ou circulaire destinés à la
détermination objective des anomalies de réfraction de l'œil.
La présente Norme internationale a la priorité sur l'ISO 15004-1, si des différences existent.
2 Références normatives
Les documents de référence suivants sont indispensables pour l'application du présent document. Pour les
références datées, seule l'édition citée s'applique. Pour les références non datées, la dernière édition du
document de référence s'applique (y compris les éventuels amendements).
ISO 15004-1, Instruments ophtalmiques — Exigences fondamentales et méthodes d'essai — Partie 1:
Exigences générales applicables à tous les instruments ophtalmiques
CEI 60601-1:2005, Appareils électromédicaux — Partie 1: Exigences générales pour la sécurité de base et
les performances essentielles
3 Termes et définitions
Pour les besoins du présent document, les termes et définitions suivants s'appliquent.
3.1
skiascope
instrument ophtalmique conçu afin d'évaluer de manière objective les anomalies de réfraction de l'œil par
l'observation dans la pupille des mouvements du reflet rétinien dû à la réflexion dans l'œil d'un faisceau de
lumière réfléchi par un miroir
NOTE Un skiascope est
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