EN ISO 11979-5:2006
(Main)Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006)
Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006)
ISO 11979-5:2006 specifies particular requirements for the biocompatibility evaluation of materials for intraocular lenses (IOLs) including the processing conditions to produce them. These requirements include evaluation of physicochemical properties that are relevant to biocompatibility. It also gives guidance on conducting an ocular implantation test.
Ophthalmische Implantate - Intraokularlinsen - Teil 5: Biokompatibilität (ISO 11979-5:2006)
Dieser Teil von ISO 11979 legt die besonderen Anforderungen an die Bewertung der Biokompatibilität von Materialien für Intraokularlinsen (IOLs) sowie der bei deren Herstellung angewendeten Verfahren bzw. Bedingungen fest. Diese Anforderungen beinhalten die Bewertung der physikalisch-chemischen Eigen-schaften, die für die Biokompatibilität von Belang sind. Zudem gibt er eine Anleitung zur Durch¬führung einer Untersuchung zur intraokularen Implantation.
Implants ophtalmiques - Lentilles intraoculaires - Partie 5: Biocompatibilité (ISO 11979-5:2006)
L'ISO 11979-5:2006 spécifie les exigences particulières de l'évaluation de la biocompatibilité des matériaux utilisés pour la fabrication des lentilles intraoculaires (LIO), y compris les conditions de traitement de leur fabrication. Ces exigences comprennent l'évaluation des propriétés physicochimiques relatives à la biocompatibilité. L'ISO 11979-5:2006 donne également des directives relatives à la mise en oeuvre d'un essai d'implantation oculaire.
Očesni vsadki (implantati) - Intraokularne leče - 5. del: Biokompatibilnost (ISO 11979-5:2006)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2006
1DGRPHãþD
SIST EN 13503-5:2002
2þHVQLYVDGNL LPSODQWDWL ,QWUDRNXODUQHOHþHGHO %LRNRPSDWLELOQRVW ,62
Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2006)
Ophthalmische Implantate - Intraokularlinsen - Teil 5: Biokompatibilität (ISO 11979-
5:2006)
Implants ophtalmiques - Lentilles intraoculaires - Partie 5: Biocompatibilité (ISO 11979-
5:2006)
Ta slovenski standard je istoveten z: EN ISO 11979-5:2006
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD
EN ISO 11979-5
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2006
ICS 11.040.70 Supersedes EN 13503-5:2001
English Version
Ophthalmic implants - Intraocular lenses - Part 5:
Biocompatibility (ISO 11979-5:2006)
Implants ophtalmiques - Lentilles intraoculaires - Partie 5: Ophthalmische Implantate - Intraokularlinsen - Teil 5:
Biocompatibilité (ISO 11979-5:2006) Biokompatibilität (ISO 11979-5:2006)
This European Standard was approved by CEN on 13 April 2006.
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 Central Secretariat 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 Central Secretariat has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Cyprus, Czech Republic, Denmark, Estonia, Finland, France,
Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania,
Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
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EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2006 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11979-5:2006: E
worldwide for CEN national Members.
Foreword
This document (EN ISO 11979-5:2006) has been prepared by Technical Committee ISO/TC 172
"Optics and optical instruments" 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 December 2006, and conflicting national
standards shall be withdrawn at the latest by December 2006.
This document supersedes EN 13503-5:2001.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of
the following countries are bound to implement this European Standard: Austria, Belgium,
Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary,
Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Endorsement notice
The text of ISO 11979-5:2006 has been approved by CEN as EN ISO 11979-5:2006 without any
modifications.
INTERNATIONAL ISO
STANDARD 11979-5
Second edition
2006-06-01
Ophthalmic implants — Intraocular
lenses —
Part 5:
Biocompatibility
Implants ophtalmiques — Lentilles intraoculaires —
Partie 5: Biocompatibilité
Reference number
ISO 11979-5:2006(E)
©
ISO 2006
ISO 11979-5:2006(E)
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ii © ISO 2006 – All rights reserved
ISO 11979-5:2006(E)
Contents Page
Foreword. iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions. 1
4 General requirements applying to biocompatibility evaluation of intraocular lenses. 2
5 Physicochemical tests . 2
6 Biological tests . 5
Annex A (normative) Exhaustive extraction test . 7
Annex B (normative) Test for leachables . 10
Annex C (normative) Hydrolytic stability. 12
Annex D (normative) Photostability test. 15
Annex E (normative) Nd-YAG laser exposure test . 17
Annex F (informative) Supplemental conditions of test for local effects after implantation. 19
Annex G (normative) Ocular implantation test . 20
Bibliography . 24
ISO 11979-5:2006(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.
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 11979-5 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 11979-5:1999), 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
iv © ISO 2006 – All rights reserved
ISO 11979-5:2006(E)
Introduction
This part of ISO 11979 follows the general principles given in ISO 10993-1. ISO 10993-1 describes the
principles governing the biological evaluation of medical devices, the definitions of categories based on the
nature and duration of contact with the body, and selection of appropriate tests. Other parts of ISO 10993
present biological test methods, tests for ethylene oxide residues, tests for degradation and principles for
sample preparation.
INTERNATIONAL STANDARD ISO 11979-5:2006(E)
Ophthalmic implants — Intraocular lenses —
Part 5:
Biocompatibility
1 Scope
This part of ISO 11979 specifies particular requirements for the biocompatibility evaluation of materials for
intraocular lenses (IOLs) including the processing conditions to produce them. These requirements include
evaluation of physicochemical properties that are relevant to biocompatibility. It also gives guidance on
conducting an ocular implantation test.
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 10993-1, Biological evaluation of medical devices — Part 1: Evaluation and testing
ISO 10993-2, Biological evaluation of medical devices ― Part 2: Animal welfare requirements
ISO 10993-3, Biological evaluation of medical devices ― Part 3: Tests for genotoxicity, carcinogenicity and
reproductive toxicity
ISO 10993-6, Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
ISO 10993-10, Biological evaluation of medical devices ― Part 10: Tests for irritation and delayed-type
hypersensitivity
ISO 10993-12, Biological evaluation of medical devices ― Part 12: Sample preparation and reference
materials
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 14971, Medical devices — Application of risk management to medical devices
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 11979-1 apply.
ISO 11979-5:2006(E)
4 General requirements applying to biocompatibility evaluation of intraocular
lenses
The evaluation of the biocompatibility of the test material shall start with an initial assessment of risk in
accordance with ISO 14971. The physicochemical tests described in Clause 5 shall first be considered. The
evaluation of the material for biological safety shall then be undertaken in accordance with the principles and
requirements of ISO 10993-1 and ISO 10993-2, taking into consideration the results from the physicochemical
tests.
Furthermore, the risk assessment shall include an assessment of the potential for material changes such as
calcification. This risk assessment should consider the history of clinical use of the material, and animal
models to test the long-term stability of the material.
Carry out the biocompatibility testing in accordance with ISO 10993-1, ISO 10993-3, ISO 10993-5,
ISO 10993-6 and ISO 10993-10 and as noted in this part of ISO 11979.
The pre-existing information on the material and all the information obtained in the evaluation process shall be
integrated in an overall risk benefit assessment in accordance with ISO 14971.
5 Physicochemical tests
5.1 General
5.1.1 The following physicochemical tests shall be considered:
a) exhaustive extraction;
b) leachables;
c) hydrolytic stability;
d) photostability against ultraviolet/visible (UV/Vis) irradiation;
e) stability against Nd-YAG laser exposure;
f) insoluble inorganics.
5.1.2 The objectives of this group of tests are:
a) to quantify possible residues from synthesis and additives or impurities from manufacturing and
packaging;
b) to q
...
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