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Irish Standard
I.S. EN ISO 11979-8:2015
Ophthalmic implants - Intraocular lenses Part 8: Fundamental requirements (ISO
11979-8:2006 + Amd 1:2011)
© CEN 2015
No copying without NSAI permission except as permitted by copyright law.
I.S. EN ISO 11979-8:2015
Incorporating amendments/corrigenda/National Annexes issued since publication:
The National Standards Authority of Ireland (NSAI) produces the following categories of formal documents:
I.S. xxx: Irish Standard — national specification based on the consensus of an expert panel and subject to public consultation.
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S.R. xxx: Standard Recommendation — recommendation based on the consensus of an expert panel and subject to public consultation.
SWiFT xxx: A rapidly developed recommendatory document based on the consensus of the participants of an NSAI workshop.
This document replaces/revises/consolidates the NSAI adoption of the document(s) indicated on the
CEN/CENELEC cover/Foreword and the following National document(s):
NOTE: The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC
document.
This document is based on:
EN ISO 11979-8:2015
Published:
2015-01-28
This document was published
under the authority of the NSAI
and comes into effect on:
ICS number:
11.040.70
2015-03-27
NOTE: If blank see CEN/CENELEC cover page
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Údarás um Chaighdeáin Náisiúnta na hÉireann
I.S. EN ISO 11979-8:2015
EN ISO 11979-8
EUROPEAN STANDARD
NORME EUROPÉENNE
EUROPÄISCHE NORM
January 2015
ICS 11.040.70
Supersedes EN ISO 11979-8:2009
English Version
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Ophthalmic implants - Intraocular lenses - Part 8: Fundamental
requirements (ISO 11979-8:2006 + Amd 1:2011)
Implants ophtalmiques - Lentilles intraoculaires - Partie 8:
Exigences fondamentales (ISO 11979-8:2006 + Amd
1:2011)
Ophthalmische Implantate - Intraokularlinsen - Teil 8:
Grundlegende Anforderungen (ISO 11979-8:2006 + Amd
1:2011)
This European Standard was approved by CEN on 7 January 2015.
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
CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2015 CEN
All rights of exploitation in any form and by any means reserved
worldwide for CEN national Members.
Ref. No. EN ISO 11979-8:2015 E
I.S. EN ISO 11979-8:2015
EN ISO 11979-8:2015 (E)
Contents
Page
Foreword ..............................................................................................................................................................3
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Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on Medical Devices .........................................................5
2
I.S. EN ISO 11979-8:2015
EN ISO 11979-8:2015 (E)
Foreword
The text of ISO 11979-8:2006 + Amd 1:2011 has been prepared by Technical Committee ISO/TC 172 “Optics
and photonics” of the International Organization for Standardization (ISO) and has been taken over as EN
ISO 11979-8:2015 by Technical Committee CEN/TC 170 “Ophthalmic optics” the secretariat of which is held
by DIN.
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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 July 2015, and conflicting national standards shall be withdrawn at the
latest by July 2015.
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 11979-8:2009.
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.
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, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
3
I.S. EN ISO 11979-8:2015
EN ISO 11979-8:2015 (E)
Table – Correlations between undated normative references and dated EN and ISO standards
Normative references
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as listed in Clause 2
Equivalent dated standard
EN
ISO
ISO 9000
EN ISO 9000:2005
ISO 9000:2005
ISO 10993-7:1995
EN ISO 10993-7:1995 1
ISO 10993-7:1995
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
ISO 11979-10
EN ISO 11979-10:2006 + A1:2014
ISO 11979-10:2006 + Amd.1:2014
ISO 14155-1:2003
EN ISO 14155-1:2009 2
)
ISO 14155-1:2003
ISO 14155-2
EN ISO 14155-2:2009
2)
ISO 14155-2:2003
ISO 14630
EN ISO 14630:2012
ISO 14630:2012
ISO 14971
EN ISO 14971:2007
ISO 14971:2007
)
1)
2)
2)
Endorsement notice
The text of ISO 11979-8:2006 + Amd 1:2011 has been approved by CEN as EN ISO 11979-8:2015 without
any modification.
1)
Withdrawn. The version available at the time of publication of the present document is EN ISO 10993-7:2008
+ AC:2009 (ISO 10993-7:2008 + Cor.1:2009).
2)
Withdrawn. The version available at the time of publication of the present document is EN ISO 14155:2011 + AC:2011
(ISO 14155:2011 + Cor.1:2011).
4
I.S. EN ISO 11979-8:2015
EN ISO 11979-8:2015 (E)
Annex ZA
(informative)
Relationship between this European Standard and the
Essential Requirements of EU Directive 93/42/EEC on Medical Devices
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This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on Medical Devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the 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.
Table ZA.1 — Correspondence between this European Standard
and Directive 93/42/EEC on Medical Devices
Clause(s)/sub-clause(s)
of this European Standard
Essential Requirements (ERs)
of Directive 93/42/EEC
Qualifying remarks/Notes
9
7.2
Sterility requirement.
Protection against ethylene oxide
and derivatives thereof in case the
device is sterilized by ethylene
oxide.
Protection against endotoxins.
6
7.3
For biocompatibility and interaction
with YAG-laser reference to
EN ISO 11979-5.
6, 9
7.5
Sterility requirement.
Protection against ethylene oxide
and derivatives thereof in case the
device is sterilized by ethylene
oxide.
Protection against endotoxins.
For biocompatibility and interaction
with YAG-laser reference to
EN ISO 11979-5.
6, 7
7.6
For biocompatibility and interaction
with YAG-laser reference to
EN ISO 11979-5.
For clinical investigation reference
to EN ISO 11979-7, 9 and -10, as
applicable.
5
I.S. EN ISO 11979-8:2015
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EN ISO 11979-8:2015 (E)
6
Clause(s)/sub-clause(s)
of this European Standard
Essential Requirements (ERs)
of Directive 93/42/EEC
Qualifying remarks/Notes
9
8.1
Sterility requirement.
Protection against ethylene oxide
and derivatives thereof in case the
device is sterilized by ethylene
oxide.
Protection against endotoxins.
10
8.3
For
shelf-life
and
transport
reference to EN ISO 11979-6.
9
8.4
Sterility requirement.
Protection against ethylene oxide
and derivatives thereof in case the
device is sterilized by ethylene
oxide.
Protection against endotoxins.
10
8.6
For
shelf-life
and
transport
reference to EN ISO 11979-6.
4, 5
9.1
For optical properties reference to
EN ISO 11979-2,
properties
for
mechanical
reference to EN ISO 11979-3,
for multifocal IOLs reference to
EN ISO 11979-9
and
for phakic IOLs reference to
EN ISO 11979-10.
4, 5, 6, 7, 10
9.2
For optical properties reference to
EN ISO 11979-2,
for
mechanical
properties
reference to EN ISO 11979-3,
for multifocal IOLs reference to
EN ISO 11979-9
and
for phakic IOLs reference to
EN ISO 11979-10.
For biocompatibility and interaction
with YAG-laser reference to
EN ISO 11979-5.
For clinical investigation reference
to EN ISO 11979-7, 9 and -10, as
applicable.
For
shelf-life
and
transport
reference to EN ISO 11979-6.
4, 5
12.7.1
For optical properties reference to
EN ISO 11979-2,
for
mechanical
properties
reference to EN ISO 11979-3,
for multifocal IOLs reference to
EN ISO 11979-9
and
for phakic IOLs reference to
EN ISO 11979-10.
11, 12
13.1
For labelling and information
reference to EN ISO 11979-4.
I.S. EN ISO 11979-8:2015
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EN ISO 11979-8:2015 (E)
Clause(s)/sub-clause(s)
of this European Standard
Essential Requirements (ERs)
of Directive 93/42/EEC
Qualifying remarks/Notes
11, 12
13.2
For labelling and information
reference to EN ISO 11979-4.
11, 12
13.3
For labelling and information
reference to EN ISO 11979-4.
11, 12
13.5
For labelling and information
reference to EN ISO 11979-4.
11, 12
13.6
For labelling and information
reference to EN ISO 11979-4.
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
7
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I.S. EN ISO 11979-8:2015
INTERNATIONAL
STANDARD
ISO
11979-8
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Second edition
2006-07-01
Ophthalmic implants — Intraocular
lenses —
Part 8:
Fundamental requirements
Implants ophtalmiques — Lentilles intraoculaires —
Partie 8: Exigences fondamentales
Reference number
ISO 11979-8:2006(E)
© ISO 2006
I.S. EN ISO 11979-8:2015
ISO 11979-8:2006(E)
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ii
© ISO 2006 – All rights reserved
I.S. EN ISO 11979-8:2015
ISO 11979-8:2006(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
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.
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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 11979-8 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 11979-8:1999) which has been technically
revised.
ISO 11979 consists of the following parts, under the general title Ophthalmic implants — Intraocular lenses:
⎯
Part 1: Vocabulary
⎯
Part 2: Optical properties and test methods
⎯
Part 3: Mechanical properties and test methods
⎯
Part 4: Labelling and information
⎯
Part 5: Biocompatibility
⎯
Part 6: Shelf-life and transport stability
⎯
Part 7: Clinical investigations
⎯
Part 8: Fundamental requirements
⎯
Part 9: Multifocal intraocular lenses
⎯
Part 10: Phakic intraocular lenses
© ISO 2006 – All rights reserved
iii
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I.S. EN ISO 11979-8:2015
I.S. EN ISO 11979-8:2015
INTERNATIONAL STANDARD
ISO 11979-8:2006(E)
Ophthalmic implants — Intraocular lenses —
Part 8:
Fundamental requirements
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1
Scope
This part of ISO 11979 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.
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 9000, Quality management systems — Fundamentals and vocabulary
ISO 10993-7:1995, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
ISO 11979-1, Ophthalmic implants — Intraocular lenses — Part 1: Vocabulary
ISO 11979-2, Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods
ISO 11979-3, Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods
ISO 11979-4, Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information
ISO 11979-5, Ophthalmic implants — Intraocular lenses — Part 5: Biocompatibility
ISO 11979-6, Ophthalmic implants — Intraocular lenses — Part 6: Shelf-life and transport stability
ISO 11979-7, Ophthalmic implants — Intraocular lenses — Part 7: Clinical investigations
ISO 11979-9, Ophthalmic implants — Intraocular lenses — Part 9: Multifocal intraocular lenses
ISO 11979-10, Ophthalmic implants — Intraocular lenses — Part 10: Phakic intraocular lenses
ISO 14155-1:2003, Clinical investigation of medical devices for human subjects — Part 1: General
requirements
ISO 14155-2, Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation
plans
ISO 14630:2005, Non-active surgical implants — General requirements
ISO 14971, Medical devices — Application of risk management to medical devices
© ISO 2006 – All rights reserved
1
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