Ophthalmic instruments - Retinoscopes (ISO 12865:2006)

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.

Ophthalmische Instrumente - Skiaskope (ISO 12865:2006)

Diese Internationale Norm legt zusammen mit ISO 15004-1 Mindestanforderungen und Prüfverfahren für handgehaltene Strich- und Fleckskiaskope fest, die zur objektiven Ermittlung von Refraktionsfehlern des Auges benutzt werden.
Wenn Unterschiede vorliegen, hat diese Internationale Norm Vorrang vor ISO 15004-1.

Instruments ophtalmiques - Skiascopes (ISO 12865:2006)

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.

Oftalmični instrumenti - Retinoskopi (ISO 12865:2006)

General Information

Status
Published
Publication Date
30-Jun-2006
Technical Committee
CEN/TC 170 - Ophthalmic optics
Current Stage
9093 - Decision to confirm - Review Enquiry
Start Date
20-Apr-2010
Completion Date
20-Apr-2010

Relations

Effective Date
22-Dec-2008
Effective Date
28-Jan-2026

Overview

EN ISO 12865:2006 is an internationally recognized standard developed by CEN and ISO that specifies minimum requirements and test methods for handheld ophthalmic instruments known as retinoscopes. This standard focuses on both streak and spot retinoscopes used for the objective determination of refractive errors in the eye. It ensures that these precision instruments meet rigorous optical, mechanical, and functional criteria to provide reliable results in clinical and optometric settings.

Key to this standard is its authoritative precedence over ISO 15004-1 when inconsistencies arise. EN ISO 12865:2006 aims to harmonize the design, performance, and testing of retinoscopes across global markets, enhancing patient safety and diagnostic accuracy.

Key Topics

  • Scope and Purpose
    The standard covers hand-held streak and spot retinoscopes for objective refraction testing, detailing minimum performance requirements and validation methods.

  • Retinoscope Types

    • Streak Retinoscopes: Produce a rectangular light beam with adjustable streak orientation and focus.
    • Spot Retinoscopes: Emit a circular light beam, often with adjustable focus.
  • Optical and Mechanical Specifications
    Requirements include:

    • Rotation capability (minimum ±90°) for streak retinoscopes.
    • Adjustable distances for real and virtual images of the lamp filament.
    • Streak image dimensions and linearity constraints, as well as spot diameter limits at specified distances.
  • Functional Requirements

    • Absence of internal reflections or scattered light during use.
    • Adjustable luminous intensity from zero to maximum, allowing precise control for examination.
    • Uniform illumination and absence of discoloration or distortion in the light image.
  • Testing Procedures

    • Use of measuring devices with at least 10% accuracy for verification.
    • Lens placement tests to confirm focus accuracy and virtual image positioning.
    • Visual inspections to ensure illumination quality and absence of artifacts.
  • Documentation and Marking
    Retinoscopes must include comprehensive usage instructions, manufacturer identification, compliance statements, and markings as per IEC 60601-1 safety requirements.

Applications

EN ISO 12865:2006 is essential for manufacturers, distributors, and healthcare providers involved with retinoscopes. Its requirements ensure that:

  • Ophthalmic Clinics and Optometry Practices receive accurate and reliable instruments to objectively assess patient refractive errors, improving diagnostic and treatment outcomes.
  • Medical Device Manufacturers comply with internationally accepted standards to enhance product quality, regulatory approval, and market access.
  • Regulatory Bodies use the standard as a benchmark for certifying and approving ophthalmic diagnostic devices.
  • Calibration and Maintenance Services apply the defined test methods to verify retinoscope performance during routine maintenance and recalibration.

Overall, adherence to EN ISO 12865:2006 supports enhanced patient safety, instrument reliability, and clinical confidence in retinoscopy procedures.

Related Standards

  • ISO 15004-1
    Fundamental requirements and test methods for general ophthalmic instruments, complementing retinoscope-specific provisions but subordinate when conflicts arise.

  • IEC 60601-1
    Medical electrical equipment general safety and essential performance requirements, crucial for electrical aspects of handheld retinoscopes.

  • ISO 12865:1998
    The previous edition of this standard, now superseded by the 2006 version with updated technical revisions.

Keywords

Retinoscope standards, EN ISO 12865, ophthalmic instruments, refractive error measurement, streak retinoscope, spot retinoscope, ophthalmic diagnostics, optical instrument testing, medical device requirements, IEC 60601-1 compliance, retinoscope calibration, eye examination equipment.

Get Certified

Connect with accredited certification bodies for this standard

BSI Group

BSI (British Standards Institution) is the business standards company that helps organizations make excellence a habit.

UKAS United Kingdom Verified

TÜV Rheinland

TÜV Rheinland is a leading international provider of technical services.

DAKKS Germany Verified

TÜV SÜD

TÜV SÜD is a trusted partner of choice for safety, security and sustainability solutions.

DAKKS Germany Verified

Sponsored listings

Frequently Asked Questions

EN ISO 12865:2006 is a standard published by the European Committee for Standardization (CEN). Its full title is "Ophthalmic instruments - Retinoscopes (ISO 12865:2006)". 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.

EN 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.

EN ISO 12865:2006 has the following relationships with other standards: It is inter standard links to EN ISO 12865:1998, EN 1911-1:1998. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

EN 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)


SLOVENSKI STANDARD
01-oktober-2006
1DGRPHãþD
SIST EN ISO 12865:2000
2IWDOPLþQLLQVWUXPHQWL5HWLQRVNRSL ,62
Ophthalmic instruments - Retinoscopes (ISO 12865:2006)
Ophthalmische Instrumente - Skiaskope (ISO 12865:2006)
Instruments ophtalmiques - Skiascopes (ISO 12865:2006)
Ta slovenski standard je istoveten z: EN ISO 12865:2006
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 12865
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2006
ICS 11.040.70 Supersedes EN ISO 12865:1998
English Version
Ophthalmic instruments - Retinoscopes (ISO 12865:2006)
Instruments ophtalmiques - Rétinoscopes (ISO Ophthalmische Instrumente - Skiaskopes (ISO
12865:2006) 12865:2006)
This European Standard was approved by CEN on 30 June 2006.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Central Secretariat or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 12865:2006: E
worldwide for CEN national Members.

Foreword
This document (EN ISO 12865:2006) has been prepared by Technical Committee ISO/TC 172
"Optics and optical instruments" in collaboration with Technical Committee CEN/TC 170
"Ophthalmic optics", the secretariat of which is held by DIN.

This European Standard shall be given the status of a national standard, either by publication of
an identical text or by endorsement, at the latest by January 2007, and conflicting national
standards shall be withdrawn at the latest by January 2007.

This document supersedes EN ISO 12865:1998.

According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.

Endorsement notice
The text of ISO 12865:2006 has been approved by CEN as EN ISO 12865:2006 without any
modifications.
INTERNATIONAL ISO
STANDARD 12865
Second edition
2006-07-01
Ophthalmic instruments — Retinoscopes
Instruments ophtalmiques — Skiascopes

Reference number
ISO 12865:2006(E)
©
ISO 2006
ISO 12865:2006(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.

©  ISO 2006
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2006 – All rights reserved

ISO 12865:2006(E)
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. Public
...

Questions, Comments and Discussion

Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.

Loading comments...