EN ISO 15004-1:2020
(Main)Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2020)
Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2020)
This document specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments and to devices for enhancing low vision. This document is also applicable to tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye.
This document is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.
Ophthalmische Instrumente - Grundlegende Anforderungen und Prüfverfahren - Teil 1: Allgemeine Anforderungen an alle ophthalmischen Instrumente (ISO 15004-1:2020)
Dieses Dokument legt grundlegende Anforderungen für nicht-invasive, aktive und nicht-aktive ophthalmische Instrumente und für Sehhilfen für Sehbehinderte fest. Dieses Dokument ist auch für Tonometer anzuwenden, jedoch nicht für andere ophthalmische Instrumente, die im Kontakt mit dem Augapfel benutzt werden.
Dieses Dokument ist nicht anzuwenden für Operationsmikroskope, Endoskope und Geräte, die zur Untersuchung oder Behandlung des Auges mit Hilfe von Lasern dienen.
Instruments ophtalmiques - Exigences fondamentales et méthodes d'essai - Partie 1: Exigences générales applicables à tous les instruments ophtalmiques (ISO 15004-1:2020)
Le présent document spécifie les exigences fondamentales s'appliquant aux instruments ophtalmiques non invasifs, actifs et non actifs, et aux dispositifs pour malvoyants. Il est également applicable aux tonomètres, mais ne s'applique pas aux autres instruments ophtalmiques utilisés au contact du globe oculaire.
Le présent document ne s'applique pas aux microscopes chirurgicaux, aux endoscopes ou aux instruments destinés à l'examen ou au traitement de l'œil par laser.
Oftalmični instrumenti - Temeljne zahteve in preskusne metode - 1. del: Splošne zahteve, uporabne za vse oftalmične instrumente (ISO 15004-1:2020)
General Information
- Status
- Published
- Publication Date
- 24-Nov-2020
- Withdrawal Date
- 30-May-2021
- Technical Committee
- CEN/TC 170 - Ophthalmic optics
- Drafting Committee
- CEN/TC 170 - Ophthalmic optics
- Current Stage
- 6060 - Definitive text made available (DAV) - Publishing
- Start Date
- 25-Nov-2020
- Completion Date
- 25-Nov-2020
Relations
- Effective Date
- 08-Jun-2022
Overview
EN ISO 15004-1:2020 - "Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments" defines the core safety, design and testing expectations for non‑invasive ophthalmic instruments, including active and non‑active devices and devices for enhancing low vision. It applies to tonometers but not to ophthalmic instruments that contact the globe of the eye (except tonometers). It explicitly excludes operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye. This edition (2020) supersedes earlier versions and has been endorsed by CEN as EN ISO 15004-1:2020.
Key topics and technical requirements
- Scope and applicability: Non‑invasive ophthalmic instruments, tonometers, low‑vision aids; exclusions for contact devices and laser/operative equipment.
- Design and risk reduction: Devices must be designed to reduce risks in line with the state of the art (links with ISO 14971 risk management).
- Performance: Instruments must achieve declared performance when used as intended and per manufacturer instructions.
- Materials & contamination control: Requirements for materials and protection against contaminants to ensure patient and user safety.
- Thermal and mechanical hazards: Limits and test approaches for surface temperatures and mechanical safety.
- Scales, displays & markings: Legibility, accuracy and appropriate manufacturer information and labelling.
- Active device requirements: Electrical safety and relevant provisions where IEC 60601‑1 applies - EN ISO 15004-1 takes precedence over IEC 60601‑1 when differences exist.
- Optical radiation hazard: Reference to Part 2 (ISO 15004‑2) for light hazard protection and measurement.
- Test methods: Includes ignitability, surface temperature testing, electrical safety checks and other test protocols.
- Information supplied by manufacturer: Mandatory accompanying documents, instructions and markings for safe use.
Practical applications and users
Who uses EN ISO 15004-1:2020:
- Manufacturers of ophthalmic instruments and low‑vision devices - for design, CE marking and regulatory compliance.
- Product development and QA teams - to set safety, testing and documentation requirements.
- Test laboratories - to perform standardized safety and performance testing (surface temperature, ignitability, electrical safety).
- Regulatory and procurement specialists - to assess conformity and select compliant ophthalmic products.
- Clinicians and biomedical engineers - to understand device safety limits and labeling expectations.
Related standards
- ISO 15004‑2:2007 - Light hazard protection (product‑specific optical safety)
- IEC 60601‑1:2005 + A1:2012 - Medical electrical equipment general requirements
- ISO 14971 - Medical device risk management
- ISO 13485 - Medical device quality management (manufacturer definition alignment)
- IEC 60695‑2‑10 / IEC 60695‑2‑11 - Glow‑wire / ignitability testing
EN ISO 15004-1:2020 is essential for safe design, testing and regulatory alignment of non‑invasive ophthalmic equipment and supports consistent international practice for ophthalmic device safety and documentation.
Frequently Asked Questions
EN ISO 15004-1:2020 is a standard published by the European Committee for Standardization (CEN). Its full title is "Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General requirements applicable to all ophthalmic instruments (ISO 15004-1:2020)". This standard covers: This document specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments and to devices for enhancing low vision. This document is also applicable to tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye. This document is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.
This document specifies fundamental requirements for non-invasive, active and non-active ophthalmic instruments and to devices for enhancing low vision. This document is also applicable to tonometers, but not to other ophthalmic instruments which are used in contact with the globe of the eye. This document is not applicable to operation microscopes, endoscopes and devices intended for laser investigation or laser treatment of the eye.
EN ISO 15004-1:2020 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 15004-1:2020 has the following relationships with other standards: It is inter standard links to EN ISO 15004-1:2009. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
EN ISO 15004-1:2020 is associated with the following European legislation: EU Directives/Regulations: 2007/47/EC, 93/42/EEC; Standardization Mandates: M/023. When a standard is cited in the Official Journal of the European Union, products manufactured in conformity with it benefit from a presumption of conformity with the essential requirements of the corresponding EU directive or regulation.
You can purchase EN ISO 15004-1:2020 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of CEN standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-januar-2021
Nadomešča:
SIST EN ISO 15004-1:2009
Oftalmični instrumenti - Temeljne zahteve in preskusne metode - 1. del: Splošne
zahteve, uporabne za vse oftalmične instrumente (ISO 15004-1:2020)
Ophthalmic instruments - Fundamental requirements and test methods - Part 1: General
requirements applicable to all ophthalmic instruments (ISO 15004-1:2020)
Ophthalmische Instrumente - Grundlegende Anforderungen und Prüfverfahren - Teil 1:
Allgemeine Anforderungen an ophthalmische Instrumente (ISO 15004-1:2020)
Instruments ophtalmiques - Exigences fondamentales et méthodes d'essai - Partie 1:
Exigences générales applicables à tous les instruments ophtalmiques (ISO 15004-
1:2020)
Ta slovenski standard je istoveten z: EN ISO 15004-1:2020
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 15004-1
EUROPEAN STANDARD
NORME EUROPÉENNE
November 2020
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 15004-1:2009
English Version
Ophthalmic instruments - Fundamental requirements and
test methods - Part 1: General requirements applicable to
all ophthalmic instruments (ISO 15004-1:2020)
Instruments ophtalmiques - Exigences fondamentales Ophthalmische Instrumente - Grundlegende
et méthodes d'essai - Partie 1: Exigences générales Anforderungen und Prüfverfahren - Teil 1: Allgemeine
applicables à tous les instruments ophtalmiques (ISO Anforderungen an ophthalmische Instrumente (ISO
15004-1:2020) 15004-1:2020)
This European Standard was approved by CEN on 5 September 2020.
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 CEN-CENELEC Management Centre 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 CEN-CENELEC Management
Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15004-1:2020 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 15004-1:2020) has been prepared by Technical Committee ISO/TC 172 "Optics
and photonics" 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 May 2021, and conflicting national standards shall be
withdrawn at the latest by May 2021.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 15004-1:2009.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 15004-1:2020 has been approved by CEN as EN ISO 15004-1:2020 without any
modification.
INTERNATIONAL ISO
STANDARD 15004-1
Second edition
2020-05
Ophthalmic instruments —
Fundamental requirements and test
methods —
Part 1:
General requirements applicable to all
ophthalmic instruments
Instruments ophtalmiques — Exigences fondamentales et méthodes
d'essai —
Partie 1: Exigences générales applicables à tous les instruments
ophtalmiques
Reference number
ISO 15004-1:2020(E)
©
ISO 2020
ISO 15004-1:2020(E)
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
ISO 15004-1:2020(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Fundamental requirements . 2
4.1 General . 2
4.2 Design . 2
4.3 Performance . 2
4.4 Combination of different devices . 2
4.5 Materials . 3
4.6 Protection against contaminants . 3
4.7 Scales and displays . 3
4.8 Thermal hazards . 3
4.9 Mechanical hazards . 3
5 Environmental conditions . 3
6 Particular requirements for active ophthalmic instruments . 3
6.1 Electrical safety . 3
6.2 Inapplicable clauses of IEC 60601-1 . 3
6.3 Optical radiation hazard . 4
7 Test methods . 4
7.1 General . 4
7.2 Ignitability . 4
7.3 Surface temperatures . 4
7.4 Electrical safety . 4
8 Information supplied by the manufacturer . 4
8.1 Accompanying documents . 4
8.2 Marking . 4
Annex A (informative) Product-related International Standards for ophthalmic instruments .6
Bibliography . 7
ISO 15004-1:2020(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction
...
EN ISO 15004-1:2020は、眼科用機器に関する標準文書であり、全ての眼科用機器に適用される基本的な要件と試験方法を定めています。この標準の主な範囲は、非侵襲的であり、活動的および非活動的な眼科用機器、並びに視力補助装置に関する要件を指定しています。特にトノメーターに適用されることが記載されていますが、眼球との接触を伴う他の眼科用機器には適用されない点も重要です。 この標準の強みは、眼科用機器の安全性と効果を確保するための明確なガイドラインを提供していることです。非侵襲的な機器に関する要件は、患者の安全を最優先に考えた設計や使用方法を促進します。また、低視力を強化する装置に関する規定は、視覚の問題を抱える人々にとって非常に重要な役割を果たします。 標準の関連性は、眼科用機器の品質向上と規制順守を支援する点にあります。医療機器市場が急速に進化する中で、EN ISO 15004-1:2020は最新の技術や実践に対応した指針を提供し、医療従事者や製造業者にとって不可欠なリソースといえるでしょう。また、ISO 15004-1:2020が示す基本要件は、業界全体での共通理解を形成し、標準化に向けた取り組みの基盤となります。 全体として、EN ISO 15004-1:2020は、眼科用機器に関する標準として、その包括的な要件により、医療の質を確保し、患者の安全を守るための重要な役割を果たしています。この標準の実施が進むことで、眼科医療の向上に寄与することが期待されます。
The EN ISO 15004-1:2020 standard provides comprehensive guidelines regarding the fundamental requirements for ophthalmic instruments. Its scope is notable for encompassing a wide range of non-invasive, active and non-active ophthalmic devices, specifically targeting those utilized for enhancing low vision, which is increasingly relevant in today’s aging population. By including tonometers within its purview, the standard ensures that essential measuring instruments undergo rigorous testing and adherence to universally accepted operational criteria. One of the strengths of this standard is its focus on general requirements applicable to all ophthalmic instruments. This uniformity fosters a clearer understanding of safety and performance expectations across various devices, which is crucial for manufacturers seeking to comply with international benchmarks. The standard promotes quality assurance in design and functionality, potentially reducing risks associated with poorly designed ophthalmic devices. Further reinforcing its relevance, the EN ISO 15004-1:2020 expressly distinguishes which instruments fall under its guidelines, notably excluding operation microscopes, endoscopes, and devices intended for laser investigations or treatments. This delineation aids manufacturers and regulatory bodies in navigating compliance requirements and ensures that specific device categories receive tailored attention in their testing and validation processes. Overall, the EN ISO 15004-1:2020 standard stands as a significant regulatory framework that not only champions the development of high-quality ophthalmic instruments but also enhances the overall safety and effectiveness of ophthalmic care.
표준 EN ISO 15004-1:2020은 안과 기구와 관련된 필수 요구 사항과 시험 방법에 대해 규정하고 있습니다. 이 문서는 비침습적이며, 능동 및 비능동 안과 기구와 저시력 보조 장치에 적용됩니다. 특히, 이 표준은 안압계를 포함하지만, 안구에 접촉하는 다른 안과 기구에는 적용되지 않습니다. 또한, 수술 현미경, 내시경 및 레이저 조사 또는 레이저 치료를 위한 장치에는 적용되지 않습니다. 이 표준의 강점 중 하나는 안과 기구의 일반적인 요구 사항을 포괄적으로 나열하고 있다는 점입니다. 이를 통해 제조업체와 사용자는 제품 개발 및 적용 과정에서 준수해야 할 기본적인 기준을 명확하게 이해할 수 있습니다. 또한, 이 표준은 안전성과 효율성을 보장하기 위한 필수 테스트 방법을 포함하고 있어서, 제품의 품질을 한층 높이는 데 기여합니다. EN ISO 15004-1:2020의 적용 범위는 현대 안과 기구 시장에서 중요한 역할을 합니다. 저시력 보조 장치를 포함한 다양한 안과 기구에 대한 요구 사항을 설정함으로써, 안과 치료의 품질을 향상시키고 환자의 안전을 보장하는 데 기여합니다. 따라서 이 표준은 안과 기구 산업의 발전과 환자 보호를 위한 중요한 문서로 자리 잡고 있습니다.
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