SIST EN ISO 15798:2002

SLOVENSKI STANDARD
01-maj-2002
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2001)
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2001)
Ophthalmische Implantate - Viskoelastische Substanzen (ISO 15798:2001)
Implants ophtalmiques - Dispositifs ophtalmiques viscoélastiques (ISO 15798:2001)
Ta slovenski standard je istoveten z: EN ISO 15798:2001
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 15798
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2001
ICS 11.040.70
English version
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO
15798:2001)
Implants ophtalmiques - Dispositifs ophtalmiques Ophthalmische Implantate - Viskoelastische Substanzen
viscoélastiques (ISO 15798:2001) (ISO 15798:2001)
This European Standard was approved by CEN on 15 June 2001.
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 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 Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom.
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© 2001 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15798:2001 E
worldwide for CEN national Members.

Page 2
Foreword
The text of the International Standard ISO 15798:2001 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 2001, and conflicting
national standards shall be withdrawn at the latest by December 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,
Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy,
Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United
Kingdom.
Endorsement notice
The text of the International Standard ISO 15798:2001 was approved by CEN as a European
Standard without any modification.
NOTE: Normative references to International Standards are listed in annex ZA (normative).

Page 3
Annex ZA (normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other
publications. These normative references are cited at the appropriate places in the text and the
publications are listed hereafter. For dated references, subsequent amendments to or revisions
of any of these publications apply to this European Standard only when incorporated in it by
amendment or revision. For undated references the latest edition of the publication referred to
applies (including amendments).
NOTE Where an International Publication has been modified by common modifications,
indicated by (mod.), the relevant EN/HD applies.
Publication Year Title EN Year
ISO 10993-1 1997 Biological evaluation of medical EN ISO 10993-1 1997
devices - Part 1: Evaluation and
testing
ISO 10993-2 1992 Biological evaluation of medical EN ISO 10993-2 1998
devices - Part 2: Animal welfare
requirements
ISO 10993-6 1994 Biological evaluation of medical EN 30993-6 1994
devices - Part 6: Tests for local
effects after implantation
ISO 10993-9 1999 Biological evaluation of medical EN ISO 10993-9 1999
devices - Part 9: Framework for
identification and quantification of
potential degradation products
ISO 10993-16 1997 Biological evaluation of medical EN ISO 10993-16 1997
devices - Part 16: Toxicokinetic
study design for degradation
products and leachables
ISO 14630 1997 Non-active surgical implants - EN ISO 14630 1997
General requirements
INTERNATIONAL ISO
STANDARD 15798
First edition
2001-06-15
Ophthalmic implants — Ophthalmic
viscosurgical devices
Implants ophtalmiques — Dispositifs ophtalmiques viscochirurgicaux
Reference number
ISO 15798:2001(E)
©
ISO 2001
ISO 15798:2001(E)
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ii © ISO 2001 – All rights reserved

ISO 15798:2001(E)
Contents Page
Foreword.iv
1 Scope .1
2 Normative references .1
3 Terms and definitions .2
4 Intended performance .3
5 Design attributes.4
6 Design evaluation .6
7 Sterilization.9
8 Product stability.10
9 Integrity and performance of the delivery system .10
10 Packaging.10
11 Information to be supplied by the manufacturer.10
Annex A (normative) Intra-ocular implantation test .12
Annex B (normative) Test for intra-ocular pressure.13
Annex C (informative) Microscopic assay for particulate matter.14
Annex D (informative) Patient numbers for clinical trials .19
Bibliography.20
ISO 15798:2001(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 International Standard may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 15798 was prepared by Technical Committee ISO/TC 172, Optics and optical
instruments, Subcommittee SC 7, Ophthalmic optics and instruments.
Annexes A and B form an integral part of this International Standard. Annexes C and D are for information only.
iv © ISO 2001 – All rights reserved

INTERNATIONAL STANDARD ISO 15798:2001(E)
Ophthalmic implants — Ophthalmic viscosurgical devices
1 Scope
This International Standard applies to ophthalmic viscosurgical devices (OVDs), a class of non-active surgical
implants with viscous and/or viscoelastic properties, intended for use during surgery in the anterior segment of the
human eye. OVDs are designed to create and maintain space, to protect intra-ocular tissues and to manipulate
tissues during surgery. OVDs are not designed to have any pharmacological effect.
This International Standard defines requirements with regard to safety for the intended performance, design
attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling and information
supplied by the manufacturer of these devices.
2 Normative references
The following normative documents contain provisions which, through reference in this text, constitute provisions of
this International Standard. For dated references, subsequent amendments to, or revisions of, any of these
publications do not apply. However, parties to agreements based on this International Standard are encouraged to
investigate the possibility of applying the most recent editions of the normative documents indicated below. For
undated references, the latest edition of the normative document referred to applies. Members of ISO and IEC
maintain registers of currently valid International Standards.
ISO 10993-1:1997, Biological evaluation of medical devices — Part 1: Evaluation and testing.
ISO 10993-2:1992, Biological evaluation of medical devices — Part 2: Animal welfare requirements.
ISO 10993-6:1994, Biological evaluation of medical devices — Part 6: Tests for local effects after implantation.
ISO 10993-9:1999, Biological evaluation of medical devices — Part 9: Framework for identification and
quantification of potential degradation products.
ISO 10993-16:1997, Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation
products and leachables.
ISO 11134:1994, Sterilization of health care products — Requirements for validation and routine control —
Industrial moist heat sterilization.
ISO 11135:1994, Medical devices — Validation and routine control of ethylene oxide sterilization.
ISO 11137:1995, Sterilization of health care products — Requirements for validation and routine control —
Radiation sterilization.
1)
ISO 11607:— , Packaging for terminally sterilized medical devices.
ISO 13408-1:1998, Aseptic processing of health care products — Part 1: General requirements.
1) To be published. (Revision of ISO 11607:1997)
ISO 15798:2001(E)
ISO 14155:1996, Clinical investigation of medical devices.
ISO 14630:1997, Non-active surgical implants — General requirements.
ISO 14971-1:1998, Medical devices — Risk management — Part 1: Application of risk analysis.
ISO 15223:2000, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied.
EN 868-1:1997, Packaging materials and systems for medical devices which are to be sterilized — Part 1: General
requirements and test methods.
EN 1041:1998, Information supplied by the manufacturer with medical devices.
EN 12442-1:2000, Animal tissues and their derivates utilized i
...