SIST EN ISO 11979-8:2017

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017)

This document specifies fundamental requirements for all types of intraocular lenses intended for
surgical implantation into the anterior segment of the human eye, excluding corneal implants and
transplants.

Ophthalmische Implantate - Intraokularlinsen - Teil 8: Grundlegende Anforderungen (ISO 11979-8:2017)

Dieser Teil von ISO 11979 legt grundlegende Anforderungen an Intraokularlinsen fest, die für die Implantation in den vorderen Abschnitt des menschlichen Auges vorgesehen sind, mit Ausnahme von Implantaten und Transplantaten für die Hornhaut.

Implants ophtalmiques - Lentilles intraoculaires - Partie 8: Exigences fondamentales (ISO 11979-8:2017)

L'ISO 11979-8:2017 spécifie les exigences fondamentales applicables à tous les types de lentilles intraoculaires destinées à l'implantation chirurgicale dans le segment antérieur de l'oeil humain, à l'exception des implants et transplants cornéens.

Očesni vsadki (implantati) - Intraokularne leče - 8. del: Temeljne zahteve (ISO 11979-8:2017)

Ta dokument določa temeljne zahteve za vse vrste intraokularnih leč, namenjenih za kirurško vsaditev v sprednji segment človeškega očesa, razen roženičnih vsadkov in presadkov.

General Information

• Status: Published
• Public Enquiry End Date: 29-May-2016
• Publication Date: 15-Aug-2017
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 6060 - National Implementation/Publication (Adopted Project)
• Start Date: 09-Jun-2017
• Due Date: 14-Aug-2017
• Completion Date: 16-Aug-2017
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: EN ISO 11979-8:2017 - Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017)

Relations

• Replaces: SIST EN ISO 11979-8:2015 - Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006 + Amd 1:2011)
• Effective Date: 01-Sep-2017
• Replaces: SIST EN ISO 11979-8:2015 - Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2006 + Amd 1:2011)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11979-8:2017
01-september-2017
1DGRPHãþD
SIST EN ISO 11979-8:2015
2þHVQLYVDGNLLPSODQWDWL,QWUDRNXODUQHOHþHGHO7HPHOMQH]DKWHYH,62

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979
-8:2017)
Ophthalmische Implantate - Intraokularlinsen - Teil 8: Grundlegende Anforderungen (ISO
11979-8:2017)
Implants ophtalmiques - Lentilles intraoculaires - Partie 8: Exigences fondamentales
(ISO 11979-8:2017)
Ta slovenski standard je istoveten z: EN ISO 11979-8:2017
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 11979-8:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11979-8:2017

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SIST EN ISO 11979-8:2017


EN ISO 11979-8
EUROPEAN STANDARD

NORME EUROPÉENNE

May 2017
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 11979-8:2015
English Version

Ophthalmic implants - Intraocular lenses - Part 8:
Fundamental requirements (ISO 11979-8:2017)
Implants ophtalmiques - Lentilles intraoculaires - Ophthalmische Implantate - Intraokularlinsen - Teil 8:
Partie 8: Exigences fondamentales (ISO 11979-8:2017) Grundlegende Anforderungen (ISO 11979-8:2017)
This European Standard was approved by CEN on 8 March 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 11979-8:2017 E
worldwide for CEN national Members.

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SIST EN ISO 11979-8:2017
EN ISO 11979-8:2017 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 5
2

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SIST EN ISO 11979-8:2017
EN ISO 11979-8:2017 (E)
European foreword
This document (EN ISO 11979-8:2017) 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 November 2017, and conflicting national standards
shall be withdrawn at the latest by November 2017.
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 11979-8:2015.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this
document.
The following referenced documents are indispensable for the application of this document. For
undated references, the latest edition of the referenced document (including any amendments) applies.
For dated references, only the edition cited applies. However, for any use of this standard ‘within the
meaning of Annex ZA’, the user should always check that any referenced document has not been
superseded and that its relevant contents can still be considered the generally acknowledged state-of-
art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a
normative reference to the corresponding EN standard, if available, and otherwise to the dated version
of the ISO or IEC standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the
extent (in whole or in part) to which they apply.
Table 1 — Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the
EN ISO
ISO standard
ISO 11979-1 EN ISO 11979-1:2012 ISO 11979-1:2012
ISO 11979-2 EN ISO 11979-2:2014 ISO 11979-2:2014
ISO 11979-3 EN ISO 11979-3:2012 ISO 11979-3:2012
ISO 11979-4 EN ISO 11979-4:2008 + A1:2012 ISO 11979-4:2008 + Amd.1:2012
ISO 11979-5 EN ISO 11979-5:2006 ISO 11979-5:2006
ISO 11979-6 EN ISO 11979-6:2014 ISO 11979-6:2014
ISO 11979-7 EN ISO 11979-7:2014 ISO 11979-7:2014
ISO 11979-9 EN ISO 11979-9:2006 + A1:2014 ISO 11979-9:2006 + Amd.1:2014
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SIST EN ISO 11979-8:2017
EN ISO 11979-8:2017 (E)
Normative references Equivalent dated standard
as listed in Clause 2 of the
EN ISO
ISO standard
EN ISO 11979-10:2006 + ISO 11979-10:2006 +
ISO 11979-10
A1:2014 Amd.1:2014
ISO 14155 EN ISO 14155:2011 + AC:2011 ISO 14155:2011 + Cor.1:2011
ISO 14630 EN ISO 14630:2012 ISO 14630:2012
ISO 14971 EN ISO 14971:2012 ISO 14971:2007
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 11979-8:2017 has been approved by CEN as EN ISO 11979-8:2017 without any
modification.

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SIST EN ISO 11979-8:2017
EN ISO 11979-8:2017 (E)
Annex ZA
(informative)

Relationship between this European Standard and the Essential
Requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered
This European Standard has been prepared under a Commission’s standardization request [M/023
concerning the development of European Standards related to medical devices] to provide one
voluntary means of conforming to essential requirements of Council Directive 93/42/EEC of 14 June
1993 concerning medical devices [OJ L 169].
Once this standard is cited in the Official Journal of the European Union under that Directive,
compliance with the normative clauses of this standard given in Table ZA.1 confers, within the limits of
the scope of this standard, a presumption of conformity with the corresponding essential requirements
of that Directive and associated EFTA regulations.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC as amended by 2007/47/EC. This
means that risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’
or ‘removed’, according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with Essential
Requirements 1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and
Annex I of Directive 93/42/EEC [OJ L 169]
Essential Requirements of Clause(s)/sub-clause(s) Remarks/Notes
Directive 93/42/EEC of this EN
ER 7.2 is only met in respect of ethylene
7.2 9.1, 9.2 oxide and bacterial endotoxins and only
in respect of manufacturing.
ER 7.5 is only met in respect of ethylene
7.5 9.1, 9.2 oxide and bacterial endotoxins and only
in respect of manufacturing.
ER 8.1 is met in respect of ethylene oxide
8.1 9.1, 9.2
and bacterial endotoxins only.
ER 8.4 is met in respect of ethylene oxide
8.4 9.1 sterilization only. Manufacturing is not
covered.
WARNING 1 — Presumption of conformity stays valid only as long as a reference to this European
Standard is maintained in the list published in the Official Journal of the European Union. Users of this
standard should consult frequently the latest list published in the Official Journal of the European
Union.
WARNING 2 — Other Union legislation may be applicable to the products falling within the scope of this
standard.
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SIST EN ISO 11979-8:2017

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SIST EN ISO 11979-8:2017
INTERNATIONAL ISO
STANDARD 11979-8
Third edition
2017-04
Ophthalmic implants — Intraocular
lenses —
Part 8:
Fundamental requirements
Implants ophtalmiques — Lentilles intraoculaires —
Partie 8: Exigences fondamentales
Reference number
ISO 11979-8:2017(E)
©
ISO 2017

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SIST EN ISO 11979-8:2017
ISO 11979-8:2017(E)

COPYRIGHT PROTECTED DOCUMENT
© 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
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ii © ISO 2017 – All rights reserved

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SIST EN ISO 11979-8:2017
ISO 11979-8:2017(E)

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Safety and performance .
...