SIST EN ISO 18369-2:2013
(Main)Ophthalmic optics - Contact lenses - Part 2: Tolerances (ISO 18369-2:2012)
Ophthalmic optics - Contact lenses - Part 2: Tolerances (ISO 18369-2:2012)
This part of ISO 18369 specifies the tolerance limits of the principal optical and physical parameters of rigid, soft and rigid scleral contact lenses.
Augenoptik - Kontaktlinsen - Teil 2: Grenzabweichungen (ISO 18369-2:2012)
Optique ophtalmique - Lentilles de contact - Partie 2: Tolérances (ISO 18369-2:2012)
L'ISO 18369-2:2012 spécifie les limites de tolérance des principaux paramètres optiques et physiques des lentilles de contact rigides, souples et sclérales rigides.
Očesna optika - Kontaktne leče - 2. del: Tolerance (ISO 18369-2:2012)
Ta del standarda ISO 18369 določa meje tolerance glavnih optičnih in fizičnih parametrov trdih, mehkih in trdih skleralnih kontaktnih leč.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 18369-2:2013
01-marec-2013
1DGRPHãþD
SIST EN ISO 18369-2:2006
2þHVQDRSWLND.RQWDNWQHOHþHGHO 7ROHUDQFH ,62
Ophthalmic optics - Contact lenses - Part 2: Tolerances (ISO 18369-2:2012)
Augenoptik - Kontaktlinsen - Teil 2: Grenzabweichungen (ISO 18369-2:2012)
Optique ophtalmique - Lentilles de contact - Partie 2: Tolérances (ISO 18369-2:2012)
Ta slovenski standard je istoveten z: EN ISO 18369-2:2012
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 18369-2:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 18369-2:2013
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SIST EN ISO 18369-2:2013
EUROPEAN STANDARD
EN ISO 18369-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
December 2012
ICS 11.040.70 Supersedes EN ISO 18369-2:2006
English Version
Ophthalmic optics - Contact lenses - Part 2: Tolerances (ISO
18369-2:2012)
Optique ophtalmique - Lentilles de contact - Partie 2: Augenoptik - Kontaktlinsen - Teil 2: Grenzabweichungen
Tolérances (ISO 18369-2:2012) (ISO 18369-2:2012)
This European Standard was approved by CEN on 30 November 2012.
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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 18369-2:2012: E
worldwide for CEN national Members.
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SIST EN ISO 18369-2:2013
EN ISO 18369-2:2012 (E)
Contents Page
Foreword .3
2
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SIST EN ISO 18369-2:2013
EN ISO 18369-2:2012 (E)
Foreword
This document (EN ISO 18369-2:2012) 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 June 2013, and conflicting national standards shall be withdrawn at
the latest by June 2013.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 18369-2:2006.
According to the CEN/CENELEC Internal Regulations, the national standards organisations 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 18369-2:2012 has been approved by CEN as a EN ISO 18369-2:2012 without any
modification.
3
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SIST EN ISO 18369-2:2013
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SIST EN ISO 18369-2:2013
INTERNATIONAL ISO
STANDARD 18369-2
Second edition
2012-12-01
Ophthalmic optics — Contact lenses —
Part 2:
Tolerances
Optique ophtalmique — Lentilles de contact —
Partie 2: Tolérances
Reference number
ISO 18369-2:2012(E)
©
ISO 2012
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SIST EN ISO 18369-2:2013
ISO 18369-2:2012(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2012
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 2012 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 18369-2:2013
ISO 18369-2:2012(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. 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 18369-2 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 18369-2:2006), of which Clause 7 and Table 4
have been technically revised.
ISO 18369 consists of the following parts, under the general title Ophthalmic optics — Contact lenses:
— Part 1: Vocabulary, classification system and recommendations for labelling specifications
— Part 2: Tolerances
— Part 3: Measurement methods
— Part 4: Physicochemical properties of contact lens materials
© ISO 2012 – All rights reserved iii
---------------------- Page: 9 ----------------------
SIST EN ISO 18369-2:2013
ISO 18369-2:2012(E)
Introduction
ISO 18369 is applicable to contact lenses, which are devices worn over the front surface of the eye in
contact with the preocular tear film. This part of ISO 18369 covers rigid (hard) corneal and scleral contact
lenses, as well as soft contact lenses. Rigid lenses maintain their own shape unsupported and are made
of transparent optical-grade plastics, such as polymethylmethacrylate (PMMA), cellulose acetate butyrate
(CAB), polyacrylate/siloxane copolymers, rigid polysiloxanes (silicone resins), butylstyrenes, fluoropolymers
and fluorosiloxanes, etc. Soft contact lenses are easily deformable and require support for proper shape. A
very large subset of soft contact lenses consists of transparent hydrogels containing water in concentrations
greater than 10 %. Soft contact lenses can also be made of non-hydrogel materials, e.g. flexible polysiloxanes
(silicone elastomers).
ISO 18369 is applicable to determining allowable tolerances of parameters and properties important for the
proper functioning of contact lenses as optical devices. ISO 18369 includes tolerances for single vision contact
lenses, bifocal lenses, lenses that alter the flux density and/or spectral composition of transmitted visible light
(tinted or pigmented contact lenses, such as those with enhancing, handling and/or opaque tints) and lenses that
significantly attenuate ultraviolet radiation (UV-absorbing lenses). ISO 18369 covers contact lenses designed
with spherical, toric and aspheric surfaces, and recommended methods for the specification of contact lenses.
iv © ISO 2012 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 18369-2:2013
INTERNATIONAL STANDARD ISO 18369-2:2012(E)
Ophthalmic optics — Contact lenses —
Part 2:
Tolerances
1 Scope
This part of ISO 18369 specifies the tolerance limits of the principal optical and physical parameters of rigid,
soft and rigid scleral contact lenses.
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 18369-1, Ophthalmic
...
SLOVENSKI STANDARD
kSIST FprEN ISO 18369-2:2012
01-oktober-2012
2þHVQDRSWLND.RQWDNWQHOHþHGHO 7ROHUDQFH ,62)',6
Ophthalmic optics - Contact lenses - Part 2: Tolerances (ISO/FDIS 18369-2:2012)
Augenoptik - Kontaktlinsen - Teil 2: Grenzabweichungen (ISO/FDIS 18369-2:2012)
Optique ophtalmique - Lentilles de contact - Partie 2: Tolérances (ISO/FDIS 18369-
2:2012)
Ta slovenski standard je istoveten z: FprEN ISO 18369-2
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
kSIST FprEN ISO 18369-2:2012 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
kSIST FprEN ISO 18369-2:2012
---------------------- Page: 2 ----------------------
kSIST FprEN ISO 18369-2:2012
EUROPEAN STANDARD
FINAL DRAFT
FprEN ISO 18369-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2012
ICS 11.040.70 Will supersede EN ISO 18369-2:2006
English Version
Ophthalmic optics - Contact lenses - Part 2: Tolerances
(ISO/FDIS 18369-2:2012)
Optique ophtalmique - Lentilles de contact - Partie 2: Augenoptik - Kontaktlinsen - Teil 2: Grenzabweichungen
Tolérances (ISO/FDIS 18369-2:2012) (ISO/FDIS 18369-2:2012)
This draft European Standard is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical
Committee CEN/TC 170.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United
Kingdom.
Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to
provide supporting documentation.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2012 CEN All rights of exploitation in any form and by any means reserved Ref. No. FprEN ISO 18369-2:2012: E
worldwide for CEN national Members.
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kSIST FprEN ISO 18369-2:2012
FprEN ISO 18369-2:2012 (E)
Contents Page
Foreword .3
2
---------------------- Page: 4 ----------------------
kSIST FprEN ISO 18369-2:2012
FprEN ISO 18369-2:2012 (E)
Foreword
This document (FprEN ISO 18369-2:2012) 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 document is currently submitted to the Unique Acceptance Procedure.
This document will supersede EN ISO 18369-2:2006.
Endorsement notice
The text of ISO/FDIS 18369-2:2012 has been approved by CEN as a FprEN ISO 18369-2:2012 without any
modification.
3
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kSIST FprEN ISO 18369-2:2012
---------------------- Page: 6 ----------------------
kSIST FprEN ISO 18369-2:2012
FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 18369-2
ISO/TC 172/SC 7
Ophthalmic optics — Contact lenses —
Secretariat: DIN
Voting begins on: Part 2:
2012-08-09
Tolerances
Voting terminates on:
2012-10-09 Optique ophtalmique — Lentilles de contact —
Partie 2: Tolérances
Please see the administrative notes on page iii
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR
TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
ISO/FDIS 183692:2012(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN
DARDS TO WHICH REFERENCE MAY BE MADE IN
©
NATIONAL REGULATIONS. ISO 2012
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kSIST FprEN ISO 18369-2:2012
ISO/FDIS 18369-2:2012(E)
Copyright notice
This ISO document is a Draft International Standard and is copyrightprotected by ISO. Except as permitted
under the applicable laws of the user’s country, neither this ISO draft nor any extract from it may be reproduced,
stored in a retrieval system or transmitted in any form or by any means, electronic, photocopying, recording
or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to 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
Email copyright@iso.org
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2012 – All rights reserved
---------------------- Page: 8 ----------------------
kSIST FprEN ISO 18369-2:2012
ISO/FDIS 18369-2:2012(E)
ISO/CEN PARALLEL PROCESSING
This Minor Revision has been developed within the International Organization for Standardization (ISO),
and processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This final draft is hereby submitted to a parallel two-month approval vote in ISO and three-month UAP vote
in CEN.
Positive votes shall not be accompanied by comments.
Negative votes shall be accompanied by the relevant technical reasons.
© ISO 2012 – All rights reserved iii
---------------------- Page: 9 ----------------------
kSIST FprEN ISO 18369-2:2012
ISO/FDIS 18369-2:2012(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. 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 18369 2 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 18369-2:2006), of which Clause 7 and Table 4
have been technically revised.
ISO 18369 consists of the following parts, under the general title Ophthalmic optics — Contact lenses:
— Part 1: Vocabulary, classification system and recommendations for labelling specifications
— Part 2: Tolerances
— Part 3: Measurement methods
— Part 4: Physicochemical properties of contact lens materials
iv © ISO 2012 – All rights reserved
---------------------- Page: 10 ----------------------
kSIST FprEN ISO 18369-2:2012
ISO/FDIS 18369-2:2012(E)
Introduction
ISO 18369 is applicable to contact lenses, which are devices worn over the front surface of the eye in
contact with the preocular tear film. This part of ISO 18369 covers rigid (hard) corneal and scleral contact
lenses, as well as soft contact lenses. Rigid lenses maintain their own shape unsupported and are made
of transparent optical grade plastics, such as polymethylmethacrylate (PMMA), cellulose acetate butyrate
(CAB), polyacrylate/siloxane copolymers, rigid polysiloxanes (silicone resins), butylstyrenes, fluoropolymers
and fluorosiloxanes, etc. Soft contact lenses are easily deformable and require support for proper shape. A
very large subset of soft contact lenses consists of transparent hydrogels containing water in concentrations
greater than 10 %. Soft contact lenses can also be made of non-hydrogel materials, e.g. flexible polysiloxanes
(silicone elastomers).
ISO 18369 is applicable to determining allowable tolerances of parameters and properties important for the
proper functioning of contact lenses as optical devices. ISO 18369 includes tolerances for single vision contact
lenses, bifocal lenses, lenses that alter the flux density and/or spectral composition of transmitted visible light
(tinted or pigmented contact lenses, such as those with enhancing, handling and/or opaque tints) and lenses that
significantly attenuate ultraviolet radiation (UV-absorbing lenses). ISO 18369 covers contact lenses designed
with spherical, toric and aspheric surfaces, and recommended methods for the specification of contact lenses.
© ISO 2012 – All rights reserved v
---------------------- Page: 11 ----------------------
kSIST FprEN ISO 18369-2:2012
---------------------- Page: 12 ----------------------
kSIST FprEN ISO 18369-2:2012
FINAL DRAFT INTERNATIONAL STANDARD ISO/
...
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