SIST EN ISO 12865:2006

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-Sep-2006
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 01-Oct-2006
• Due Date: 01-Oct-2006
• Completion Date: 01-Oct-2006
• Ref Project: EN ISO 12865:2006 - Ophthalmic instruments - Retinoscopes (ISO 12865:2006)

Relations

• Replaces: SIST EN ISO 12865:2000 - Ophthalmic instruments - Retinoscopes (ISO 12865:1998)
• Effective Date: 22-Dec-2008
• Refers: SIST EN 1911-1:1999 - Stationary source emissions - Manual method of determination of HCl - Part 1: Sampling of gases
• Effective Date: 28-Jan-2026

Overview

SIST EN ISO 12865:2006 is a European and international standard specifying the minimum requirements and test methods for hand-held retinoscopes. Developed by CEN and ISO, this standard is critical for manufacturers and users of ophthalmic instruments designed for the objective determination of refractive errors of the eye. The document applies to both streak and spot retinoscopes and takes precedence over ISO 15004-1 in the case of differing requirements.

The standard is essential for quality assurance, compliance, and safety within ophthalmology, ensuring retinoscope devices meet consistent performance, marking, and accompanying documentation requirements.

Key Topics

• Scope and Applicability

  • Covers minimum requirements, optical and mechanical properties, and test methods for hand-held streak and spot retinoscopes.
  • Applicable to instruments used for objectively assessing refractive errors in clinical and optometric environments.

• Device Requirements

  • Outlines optical and mechanical parameters for retinoscope functionality, including beam adjustability and image clarity.
  • Specifies physical characteristics of both streak and spot retinoscopes.

• Testing Procedures

  • Describes standardized test methods for verifying compliance with minimum requirements using precision measuring devices.
  • Includes visual and measurement-based evaluations for performance characteristics.

• Construction and Functionality

  • Details expectations for internal reflections, adjustability, and illumination quality of light beams.
  • Requires continuous adjustment and high-quality image projection for accurate assessments.

• Marking and Documentation

  • Mandates clear, durable labeling with manufacturer and model information.
  • Requires comprehensive instructions for use, including compliance references and transport guidelines.

Applications

• Ophthalmic Clinics and Practices

  • Enables eye care professionals to objectively determine patient refractive errors, essential for accurate diagnosis and prescription.
  • Ensures reliable, repeatable clinical assessments and enhances patient safety.

• Medical Device Manufacturing

  • Guides manufacturers in designing, producing, and testing compliant retinoscopes for the global market.
  • Streamlines regulatory approval by meeting recognized international quality standards.

• Quality Control and Compliance

  • Supports regulatory bodies and healthcare providers in verifying that devices meet stringent international safety and performance criteria.
  • Reduces risk of device failure or inaccuracy during eye examinations.

Related Standards

• ISO 15004-1: Ophthalmic Instruments - Fundamental Requirements and Test Methods

  • Covers general requirements for all ophthalmic instruments; SIST EN ISO 12865:2006 specifies additional criteria for retinoscopes and takes precedence when conflicting.

• IEC 60601-1: Medical Electrical Equipment - General Requirements for Basic Safety and Essential Performance

  • Specifies safety and performance requirements for medical electrical equipment, including marking and documentation obligations.

• EN ISO 12865:1998 (Superseded)

  • Previous edition replaced by the 2006 version with updated and technically revised requirements.

By adhering to SIST EN ISO 12865:2006, healthcare professionals, manufacturers, and regulatory authorities can ensure that hand-held retinoscopes used in ophthalmology are safe, effective, and standardized for consistent global application. This supports accurate eye examinations, high patient care standards, and international trade of ophthalmic devices.

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)
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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
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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
...