SIST EN ISO 18369-2:2017
(Main)Ophthalmic optics - Contact lenses - Part 2: Tolerances (ISO 18369-2:2017)
Ophthalmic optics - Contact lenses - Part 2: Tolerances (ISO 18369-2:2017)
ISO 18369-2:2017 specifies the tolerance limits of the principal optical and physical parameters of rigid corneal, rigid scleral and soft contact lenses at the time of manufacture.
These tolerances might not apply to other purposes, for example, shelf-life studies.
Augenoptik - Kontaktlinsen - Teil 2: Grenzabweichungen (ISO 18369-2:2017)
Dieser Teil von ISO 18369 legt die Grenzabmaße bzw. Grenzabweichungen für die optischen und physikali-schen Eigenschaften von formstabilen Korneal- und formstabilen Skleral- und weichen Kontaktlinsen zum Zeitpunkt der Herstellung fest.
Diese Grenzabmaße bzw. Grenzabweichungen können nicht für andere Zwecke, wie z. B. Haltbarkeitsstudien, angewendet werden,
Optique ophtalmique - Lentilles de contact - Partie 2: Tolérances (ISO 18369-2:2017)
ISO 18369-2:2017 spécifie les limites de tolérance des principaux paramètres optiques et physiques des lentilles de contact cornéennes rigides, sclérales rigides et souples au moment de leur fabrication.
Ces tolérances peuvent ne pas s'appliquer à d'autres fins, par exemple, à des études de durée de conservation.
Očesna optika - Kontaktne leče - 2. del: Tolerance (ISO 18369-2:2017)
Ta dokument določa tolerančne meje glavnih optičnih in fizikalnih parametrov trdih roženičnih, trdih beločničnih in mehkih kontaktnih leč med izdelavo.
Te tolerance se morda ne uporabljajo za druge namene, na primer za študije roka uporabnosti.
General Information
Relations
Overview
EN ISO 18369-2:2017 (Ophthalmic optics - Contact lenses - Part 2: Tolerances) is a CEN-adopted ISO standard that defines the manufacturing tolerance limits for the principal optical and physical parameters of rigid corneal, rigid scleral and soft contact lenses. The standard specifies how dimensional, optical and some material property tolerances are to be interpreted and tested at the time of manufacture. It also clarifies that these tolerance limits might not apply for other purposes (for example, shelf‑life studies).
Key topics and requirements
- Scope of tolerances: Dimensional and optical tolerances for rigid and soft lenses (e.g., back optic zone radius/base curve, sagittal depth, total diameter, centre thickness, back vertex power, cylinder power and axis).
- Testing and conditioning: Lenses shall be equilibrated in standard saline or packaging solution prior to measurement as described in the referenced test methods.
- Conformance criteria: The standard describes three approaches to demonstrate conformance - 100% inspection, acceptance sampling, and statistical estimation of performance (process assessment).
- Finish and cosmetic quality: Requirements for inclusions, surface imperfections, fenestrations and edge contour when examined under magnification (minimum 7×).
- UV transmittance: Rules for classifying and measuring lenses that claim ultraviolet attenuation (Class 1 or Class 2 absorbers).
- Deviations and risk justification: For stock soft lenses, manufacturers can deviate from the listed tolerances only when supported by clinical data (ISO 11980) and a risk assessment (ISO 14971). Custom lenses are treated separately.
- Reference test methods: Measurement methods are specified in related documents (notably ISO 18369-3 and ISO 18369-4).
Applications and who uses this standard
EN ISO 18369-2:2017 is practical for:
- Contact lens manufacturers - to define production tolerances, quality specifications and design files.
- Quality assurance and production engineers - for setting inspection plans (100% inspection or sampling) and acceptance criteria.
- Independent testing laboratories - for verifying dimensional and optical compliance using ISO test methods.
- Regulatory and conformity assessment bodies - to evaluate product claims and evidence of conformance.
- Clinicians and procurement specialists - to understand expected manufacturing variability when selecting stock or custom lenses.
Related standards
- ISO 18369-1 - Vocabulary, classification and labelling recommendations
- ISO 18369-3 - Measurement methods (referenced for all tests)
- ISO 18369-4 - Physicochemical properties of contact lens materials
- ISO 11980 - Clinical data guidance (when justifying deviations)
- ISO 14971 - Risk management for medical devices
Keywords: EN ISO 18369-2:2017, contact lens tolerances, ophthalmic optics, manufacturing tolerances, rigid contact lenses, soft contact lenses, ISO 18369 series, contact lens testing.
Frequently Asked Questions
SIST EN ISO 18369-2:2017 is a standard published by the Slovenian Institute for Standardization (SIST). Its full title is "Ophthalmic optics - Contact lenses - Part 2: Tolerances (ISO 18369-2:2017)". This standard covers: ISO 18369-2:2017 specifies the tolerance limits of the principal optical and physical parameters of rigid corneal, rigid scleral and soft contact lenses at the time of manufacture. These tolerances might not apply to other purposes, for example, shelf-life studies.
ISO 18369-2:2017 specifies the tolerance limits of the principal optical and physical parameters of rigid corneal, rigid scleral and soft contact lenses at the time of manufacture. These tolerances might not apply to other purposes, for example, shelf-life studies.
SIST EN ISO 18369-2:2017 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.
SIST EN ISO 18369-2:2017 has the following relationships with other standards: It is inter standard links to SIST EN ISO 18369-2:2013. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.
You can purchase SIST EN ISO 18369-2:2017 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 SIST standards.
Standards Content (Sample)
SLOVENSKI STANDARD
01-november-2017
1DGRPHãþD
SIST EN ISO 18369-2:2013
2þHVQDRSWLND.RQWDNWQHOHþHGHO 7ROHUDQFH ,62
Ophthalmic optics - Contact lenses - Part 2: Tolerances (ISO 18369-2:2017)
Augenoptik - Kontaktlinsen - Teil 2: Grenzabweichungen (ISO 18369-2:2017)
Optique ophtalmique - Lentilles de contact - Partie 2: Tolérances (ISO 18369-2:2017)
Ta slovenski standard je istoveten z: EN ISO 18369-2:2017
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EN ISO 18369-2
EUROPEAN STANDARD
NORME EUROPÉENNE
September 2017
EUROPÄISCHE NORM
ICS 01.040.11; 11.040.70 Supersedes EN ISO 18369-2:2012
English Version
Ophthalmic optics - Contact lenses - Part 2: Tolerances
(ISO 18369-2:2017)
Optique ophtalmique - Lentilles de contact - Partie 2: Augenoptik - Kontaktlinsen - Teil 2:
Tolérances (ISO 18369-2:2017) Grenzabweichungen (ISO 18369-2:2017)
This European Standard was approved by CEN on 1 July 2017.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18369-2:2017 E
worldwide for CEN national Members.
Contents Page
European foreword . 3
European foreword
This document (EN ISO 18369-2:2017) 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 March 2018, and conflicting national standards shall
be withdrawn at the latest by March 2018.
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 18369-2:2012.
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, Former Yugoslav Republic of Macedonia,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta,
Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
Endorsement notice
The text of ISO 18369-2:2017 has been approved by CEN as EN ISO 18369-2:2017 without any
modification.
INTERNATIONAL ISO
STANDARD 18369-2
Third edition
2017-08
Ophthalmic optics — Contact lenses —
Part 2:
Tolerances
Optique ophtalmique — Lentilles de contact —
Partie 2: Tolérances
Reference number
ISO 18369-2:2017(E)
©
ISO 2017
ISO 18369-2:2017(E)
© ISO 2017, Published in Switzerland
All rights reserved. Unless otherwise specified, 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
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Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
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ii © ISO 2017 – All rights reserved
ISO 18369-2:2017(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General . 1
4.1 Tolerance limits for contact lenses . 1
4.2 Conformance criteria for testing products . 2
4.3 Conditioning of contact lenses prior to testing . 2
4.4 Transmittance of ultraviolet radiation . 2
4.5 Requirements for finish . 2
4.5.1 Inclusions and surface imperfections . 2
4.5.2 Fenestrations. 2
4.5.3 Edge contour and finish . 2
4.6 Additional properties . 2
5 Tolerances for rigid contact lenses. 2
6 Tolerances for soft contact lenses . 4
Bibliography . 7
ISO 18369-2:2017(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 and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation on the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO’s adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following
URL: w w w . i s o .org/ iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee
SC 7, Ophthalmic optics and instruments.
This third edition cancels and replaces the second edition (ISO 18369-2:2012), which has been
technically revised.
A list of all parts in the ISO 18369 series
...
記事のタイトル：SIST EN ISO 18369-2:2017 - 眼科光学 - コンタクトレンズ - 第2部：許容範囲（ISO 18369-2:2017） 記事内容：本文書は、製造時の硬性角膜、硬性硝子体およびソフトコンタクトレンズの主要な光学的および物理的パラメータの許容限界を規定しています。 これらの許容限界は、例えば販売期間の研究など、他の目的には適用されない場合があります。
The article discusses the SIST EN ISO 18369-2:2017 standard, which specifies the tolerance limits for the optical and physical parameters of rigid corneal, rigid scleral, and soft contact lenses during manufacturing. It notes that these tolerance limits may not be applicable for other purposes such as shelf-life studies.
記事のタイトル：SIST EN ISO 18369-2:2017 - 眼科光学 - コンタクトレンズ - パート2：許容範囲（ISO 18369-2:2017） 記事内容：この文書は、製造時の硬質角膜、硬質虹彩と柔軟なコンタクトレンズの主要な光学的および物理的パラメータの許容範囲を指定しています。 これらの許容範囲は、他の目的（たとえば、商品の賞味期限の研究）には適用されない可能性があります。
The article discusses SIST EN ISO 18369-2:2017, which is a standard that defines the tolerance limits for various optical and physical parameters of rigid corneal, rigid scleral, and soft contact lenses during their manufacturing process. It is important to note that these tolerances may not be applicable for other purposes such as shelf-life studies.
기사 제목: SIST EN ISO 18369-2:2017 - 안과 광학 - 콘택트렌즈 - 제2부: 허용 범위 (ISO 18369-2:2017) 기사 내용: 이 문서는 경질 각막, 경질 공막 및 부드러운 콘택트렌즈의 주요 광학 및 물리적 매개변수의 허용 한계를 제조 단계에서 명시합니다. 이러한 허용 한계는 다른 목적, 예를 들어 유통기한 연구에는 적용되지 않을 수 있습니다.
기사 제목: SIST EN ISO 18369-2:2017 - 안과 광학 - 콘택트렌즈 - 제 2 부 : 허용 범위 (ISO 18369-2:2017) 기사 내용: 이 문서는 경질각막, 경질공막 및 부드러운 콘택트렌즈의 주요 광학 및 물리적 매개변수의 허용 한계를 제조 시간에 명시합니다. 이러한 허용 한계는 예를 들어 유통 기간 연구와 같은 다른 목적에는 적용되지 않을 수 있습니다.
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