EN ISO 11979-4:2000

Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-4:2000)

Migrated from Progress Sheet (TC Comment) (2000-07-10): P/ISO instead of UAP (TC Res 4 & 6/1994) (CC/971118) ++ 980112: We missed the // procedure and will try to do it anyway! Indeed ISO ++ forgot to inform us. ISO will extend the ISO DIS vote (launched mid-december) ++ of 1 month in order to make the // vote still possible. CEN/TC 170 secr. is ++ informed and will send us immediately the German version, she will also be ++ contacted by ISO. (TA/980112) ++ Contact Mr Vyze ext 850 when processing this project through each stage

Ophthalmische Implantate - Intraokularlinsen - Teil 4: Etikettierung und Information (ISO 11979-4:2000)

Dieser Teil von ISO 11979 legt Anforderungen an die Etikettierung von Intraokularlinsen (IOLs) und die in oder auf deren Verpackung anzugebenden Informationen fest. ANMERKUNG: Dieser Teil von ISO 11979 versucht, die weltweit bestehenden Anforderungen an die Etikettierung von Intraokularlinsen zu harmonisieren. Nationale Anforderungen können jedoch zusätzliche Regelungen beinhalten.

Implants ophtalmiques - Lentilles intraoculaires - Partie 4: Etiquetage et informations (ISO 11979-4:2000)

Očesni vsadki (implantati) - Intraokularne leče - 4. del: Označevanje in informacije (ISO 11979-4:2000)

General Information

• Status: Withdrawn
• Publication Date: 14-Jun-2000
• Withdrawal Date: 02-Dec-2008
• ICS: 11.040.70 - Ophthalmic equipment
• Technical Committee: CEN/TC 170 - Ophthalmic optics
• Drafting Committee: CEN/TC 170 - Ophthalmic optics
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Start Date: 03-Dec-2008
• Completion Date: 03-Dec-2008
• Ref Project: SIST EN ISO 11979-4:2000 - Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-4:2000)

Relations

• Replaced By: EN ISO 11979-4:2008 - Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-4:2008)
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11979-4:2000
01-november-2000
2þHVQLYVDGNLLPSODQWDWL,QWUDRNXODUQHOHþHGHO2]QDþHYDQMHLQLQIRUPDFLMH
,62
Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-
4:2000)
Ophthalmische Implantate - Intraokularlinsen - Teil 4: Etikettierung und Information (ISO
11979-4:2000)
Implants ophtalmiques - Lentilles intraoculaires - Partie 4: Etiquetage et informations
(ISO 11979-4:2000)
Ta slovenski standard je istoveten z: EN ISO 11979-4:2000
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 11979-4:2000 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11979-4:2000

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SIST EN ISO 11979-4:2000

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SIST EN ISO 11979-4:2000

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SIST EN ISO 11979-4:2000

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SIST EN ISO 11979-4:2000

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SIST EN ISO 11979-4:2000
INTERNATIONAL ISO
STANDARD 11979-4
First edition
2000-06-15
Ophthalmic implants — Intraocular
lenses —
Part 4:
Labelling and information
Implants ophtalmiques — Lentilles intraoculaires —
Partie 4: Étiquetage et informations
Reference number
ISO 11979-4:2000(E)
©
ISO 2000

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SIST EN ISO 11979-4:2000
ISO 11979-4:2000(E)
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ii © ISO 2000 – All rights reserved

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SIST EN ISO 11979-4:2000
ISO 11979-4:2000(E)
Contents Page
Foreword.iv
Introduction.v
1 Scope .1
2 Normative reference .1
3 Terms and definitions .1
4 Labelling .1
5 Package insert.3
6 Self-adhesive label.3
Annex A (informative) Selected terms and definitions.5
Bibliography.6
© ISO 2000 – All rights reserved iii

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SIST EN ISO 11979-4:2000
ISO 11979-4:2000(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 3.
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 part of ISO 11979 may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 11979-4 was prepared by Technical Committee ISO/TC 172, Optics and optical
instruments, Subcommittee SC 7, Ophthalmic optics and instruments.
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
Annex A of this part of ISO 11979 is for information only.
iv © ISO 2000 – All rights reserved

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SIST EN ISO 11979-4:2000
ISO 11979-4:2000(E)
Introduction
This part of ISO 11979 contains requirements and guidance for the labelling of intraocular lenses and the
information supplied with them.
Labelling requirements for medical devices in general are given in EN 1041. However, in order to provide correct
and necessary information to the ophthalmic surgeon, some additional information is required for intraocular
lenses. This information concerns technical and optical data as well as information about the materials used.
NOTE It always was and still is the intention of the Technical Committees ISO/TC 172/SC 7 and CEN/TC 170 to prepare
identical ISO and CEN (European Committee for Standardization) standards on intraocular lenses. However, during the
preparation of part 7 of this series, problems were encountered with normative references to the existing ISO 14155 and EN 540
horizontal standards on clinical investigation of medical devices, which are similar but not identical.
ISO and CEN principles concerning normative references made it impossible to continue the preparation of identical
International and European Standards on the clinical investigation of intraocular lenses. As a result, two different standards
series have had to be prepared. For this part of ISO 11979, identical versions exist for ISO and CEN (ISO 11979-4 and
EN ISO 11979-4). For those parts where no identical versions exist, it is the intention of ISO/TC 172/SC 7 and CEN/TC 170 to
revise these standards with the goal to end up with identical ones as soon as identical ISO and CEN horizontal standards on
clinical investigations become available.
© ISO 2000 – All rights reserved v

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