EN ISO 15798:2001

Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2001)

Migrated from Progress Sheet (TC Comment) (2000-07-10): Contact Mr Vyze ext 850 when processing this project through each stage

Ophthalmische Implantate - Viskoelastische Substanzen (ISO 15798:2001)

Diese Internationale Norm befasst sich mit ophthalmischen viskoelastischen Substanzen, einer Klasse nicht-aktiver chirurgischer Implantate mit viskosen und/oder viskoelastischen Eigenschaften, die für den Einsatz bei chirurgi-schen Eingriffen im Vorderabschnitt des menschlichen Auges bestimmt sind. Viskoelastische Substanzen wurden zur Schaffung und Aufrechterhaltung von Raum, zum Schutz der Intraokulargewebe und zur Manipulation von Gewebe während des chirurgischen Eingriffs entwickelt. Der Zweck von viskoelastischen Substanzen besteht nicht darin, eine pharmakologische Wirkung zu erzielen.
Mit Bezug auf die Sicherheit legt diese Internationale Norm Anforderungen für die beabsichtigte Funktion, Konstruktionsmerkmale, vorklinische und klinische Auswertungen, Sterilisation, Ver-packung, Kennzeichnung und die Bereitstellung von Informationen durch den Hersteller dieser Produkte sowie für Prüfverfahren fest.

Implants ophtalmiques - Dispositifs ophtalmiques viscoélastiques (ISO 15798:2001)

Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2001)

General Information

• Status: Withdrawn
• Publication Date: 14-Jun-2001
• Withdrawal Date: 02-Feb-2010
• 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-Feb-2010
• Completion Date: 03-Feb-2010
• Ref Project: SIST EN ISO 15798:2002 - Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2001)

Relations

• Replaced By: EN ISO 15798:2010 - Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010)
• Effective Date: 22-Dec-2008
• Corrected By: EN ISO 15798:2001/AC:2005 - Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2001)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 15798:2002
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
SIST EN ISO 15798:2002 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 15798:2002

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SIST EN ISO 15798:2002
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.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36  B-1050 Brussels
© 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.

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SIST EN ISO 15798:2002
Page 2
EN ISO 15798:2001
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).

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SIST EN ISO 15798:2002
Page 3
EN ISO 15798:2001
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

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SIST EN ISO 15798:2002

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SIST EN ISO 15798:2002
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

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SIST EN ISO 15798:2002
ISO 15798:2001(E)
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ii © ISO 2001 – All rights reserved

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SIST EN ISO 15798:2002
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 2001 – All rights reserved iii

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SIST EN ISO 15798:2002
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

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SIST EN ISO 15798:2002
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 2001 – All rights reserved 1

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SIST EN ISO 15798:2002
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 in the manufacture of medical devices — Part 1:
Analysis and management of risk.
EN 12442-2:2000, Animal tissues and their derivates utilized in the manufacture of medical devices — Part 2:
Controls on sourcing, collection and handling.
EN 12442-3:2000, Animal tissues and their derivates utilized in the manufacture of medical devices — Part 3:
Validation of elimination and/or inactivation of viruses and other transmissible agents.
USP 24 <85>, United States Pharmacopoeia, 24th revision, <85> Bacterial endotoxins test.
3 Terms and definitions
For the purposes of this International Standard, the following terms and definitions apply.
3.1
delivery system
sealed container in which the product is supplied and any additional components provided to introduce the product
into the eye
3.2
elasticity
tendency of a body to return to its original shape after being deformed in some way
NOTE Elasticity is quantitatively defined as stress (the force generated within the body) divided by strain (the change in
dimensions of the body).
3.3
lost to follow-up patient
subject in the clinical trial for whom the final post-operative case report is overdue and who cannot be contacted
despite extensive written and telephone follow-ups to determine their final clinical outcome
3.4
ophthalmic viscosurgical device
OVD
generic term that includes a variety of materials with viscous and/or viscoelastic properties, that are designed to
create and maintain space, to protect intra-ocular tissues and to manipulate tissues during surgery in the anterior
segment of the human eye
2 © ISO 2001 – All rights reserved

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SIST EN ISO 15798:2002
ISO 15798:2001(E)
3.5
primary container
vial or syringe that contains the OVD
NOTE This container forms part of the delivery system
3.6
rheologically active component
compound or mixture of compounds in the finished OVD giving the product viscous and/or viscoelastic properties
3.7
serious adverse event
intra-operative or post-operative adverse event that is potentially sight-threatening
NOTE Adapted from ISO 14155.
3.8
shear viscosity
tendency of a substance to resist deformation when subjected to stress
NOTE 1 Quantitatively, shear viscosity is the quotient of shear stress divided by shear rate in steady shear flow.
.
NOTE 2 It is expressed in millipascal seconds (mPa s) [previously expressed in centipoise (cP)].
3.9
sterile barrier
pouch containing the product and delivery system that maintains sterility during transport and storage
3.10
storage container
that part of the packaging intended to protect the device during transport and storage, containing a package insert
and a sealed, sterile pouch within which is the product and delivery system
3.11
viscoelastic
having both viscous and elastic properties
3.12
zero shear viscosity
steady state shear viscosity at vanishing shear rate
.
NOTE It is expressed in millipascal seconds (mPa s) [previously measured in centipoise (cP)].
4 Intended performance
The general requirements for the intended performance of non-active surgical implants outlined in ISO 14630 shall
apply. In addition, the manufacturer shall describe and document the functional characteristics of the OVD in terms
of its:
a) chemical composition;
b) rheological properties;
c) effectiveness in protecting the corneal endothelium.
© ISO 2001 – All rights reserved 3

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SIST EN ISO 15798:2002
ISO 15798:2001(E)
5 Design attributes
5.1 General
The general requirements for non-active surgical implants outlined in ISO 14630 shall apply.
All testing requirements described below shall be performed with the finished, sterilized product.
NOTE Tests described herein are intended to apply when qualifying materials but not necessarily apply as a routine quality
assurance/control programme.
The purity of water used shall be Water for Injection (in accordance with Pharmacopoeia Europe/USP 24/JP).
5.2 Characterization of the rheologically active components
5.2.1 Chemical description
The manufacturer shall provide a description of each rheologically active component in the product. The raw
materials used in its manufacture shall be listed, along with their quality specifications. These shall comply with
recognized compendial standards wherever possible. If the rheologically active component is derived from animal
sources the requirements of EN 12442-1, EN 12442-2, and EN 12442-3 shall apply.
If the rheologically active component is a high-molecular mass organic polymer, the repeating subunits that
comprise it shall be chemically identified and the linkages between them described. Any crosslinking shall also be
described.
The nature of the mixture of the rheologically active component in the finished product shall be described (e.g.
dissolved, dispersed, etc.). If in solution, the solubility of the rheologically active component in the solvent at the
storage temperature and at 25 °C � 2 °C shall be stated.
5.2.2 Concentration
The concentration of each rheologically active component material in the finished product shall be reported as
weight of material per unit volume of solution. Since the testing methodology may affect the actual concentration
reported, the standard physical or chemical techniques utilized shall be described.
5.2.3 Molecular mass distribution
If the rheologically active component of the OVD is a polymer, the average molecular mass shall be reported.
It is recognized that many OVDs contain high molecular mass polymers that are polydispersed and that the
molecular mass distribution may be complex. In these circumstances the manufacturer shall conduct and report
such additional tests as are necessary to provide an adequate description of the molecular mass distribution of the
components in the finished product. Standard methods shall be used wherever possible.
5.3 Characterization of the finished product
5.3.1 General
The rheological and optical properties of OVDs are physical characteristics that determine their performance in
ophthalmic surgery. It is therefore imperative that the physical properties of OVDs identified below are fully and
accurately described. The rheological properties shall be measured at the conditions expected and relevant at the
time of use.
4 © ISO 2001 – All rights reserved

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SIST EN ISO 15798:2002
ISO 15798:2001(E)
5.3.2 Shear viscosity
The shear viscosity of the product as provided to the end-user shall be measured over the range of shear rates that
are likely to be encountered during routine use of the device. Measurements shall be made at 25 °C� 2 °C. The
test equipment and other conditions of measurement shall be documented.
�1
NOTE The suggested shear rate range is from 0,001 s at one extreme, approximate to zero shear, when the viscoelastic
�1
material is stationary within the anterior chamber, to a shear rate of approximately 1 000 s at the other extreme, approximate
to the conditions when the viscoelastic material is being injected into the eye though a cannula. It is recognized that, for
products of low viscosity, it is impossible to measure the shear viscosity at very low shear rates. In such circumstances the
�1
viscosity can be measured at shear rates from 1 000 s to the lowest shear rate at which the viscosity can be practically
6 . �1
determined. For products of very high viscosity (W 2 � 10 mPa s ), shear rates below 0,001 s may be required to determine
the zero shear viscosity.
The viscosity-shear rate relationship shall be graphically presented on a standard plot of log viscosity vs. log shear
rate. The viscosity shall be measured using a rotational viscometer under standard conditions. The zero shear
viscosity is determined as the steady-state shear viscosity at vanishing shear rate. For highly viscous solutions,
measurement with a constant-stress rheometer is preferred.
5.3.3 Elasticity
The elasticity of the OVD shall be measured at frequencies from 0,01 Hz to 20 Hz. Measurements shall be made at
25 °C � 2 °C. The test equipment and other conditions of measurement shall be documented. Both the log viscous
and elastic moduli shall be plotted against the log frequency. Data can also be presented as a plot of percent
elasticity against log frequency.
5.3.4 Chemical description of the components
The manufacturer shall document the general nature of the solvent, accompanied by a detailed list of each
component, the rationale for its inclusion, and its molar concentration in the finished product. Wherever possible
components shall comply with compendial standards.
5.3.5 pH
The pH of the finished product shall be measured with a calibrated pH meter at 25 °C� 2 °C. The pH of the product
shall be between 6,8 and 7,6.
The pH of the product should be close to that of the aqueous humor (pH 7,38) in order to prevent damage to the
corneal endothelial cells. In vitro studies have shown that the pH range tolerated by the endothelium narrows as
exposure time increases.
5.3.6 Chemical and biological contaminants
The identification of potentially hazardous chemical or biological contaminants shall be determined by a risk
analysis. For raw materials of biological origin, these contaminants can include proteins, nucleic acids, or other
biological materials. Contaminants of the finished product derived from the source materials or from the
manufacturing process (e.g. crosslinking agents and antioxidants) that are potentially hazardous to the tissues of
the eye or systemically hazardous shall be identified, whenever possible, and their concentrations in the finished
product reported.
NOTE Droplets of silicone lubricant, derived from the syringe, are frequent contaminants, often misinterpreted as air
bubbles or particulates. Contamination of the product from this source should be considered in the risk assessment.
Contaminants shall be determined using standard analytical methods when available, and all methods shall be
described. Limits for identified contaminants shall be set and included. Testing for the biological effects of these
contaminants during evaluation of biological safety may be required if the risk analysis determines it necessary.
© ISO 2001 – All rights reserved 5

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SIST EN ISO 15798:2002
ISO 15798:2001(E)
5.3.7 Osmolality
The manufacturer shall determine and document the osmolality range of the OVD. Osmolality of the finished
product shall not be less than 200 mOsm/kg or greater than 400 mOsm/kg. Osmolality shall be determined using
either a vapour pressure or cryoscopic osmometer under standard conditions.
5.3.8 Spectral transmittance
The spectral transmittance of the finished product shall be recorded over the range 200 nm to 1 200 nm. Results
shall be presented graphically, plotting percent transmission against wavelength.
5.3.9 Particulates
There is potential for adverse events [such as an excessive or prolonged elevation in intra-ocular pressure (IOP)]
arising as a result of particles of certain sizes and characteristics in the finished product.
A risk assessment shall evaluate the potential for contamination by, or formation of, particulates in the product
during manufacture, the conditions expected during transport and storage and during use of the product. In
particular the potential for aggregation, polymerization and adhesion of particles to ocular tissues shall be taken
into account.
NOTE 1 OVDs containing synthetic polymers are likely to be at significantly higher risk of formation of microgels, which are
difficult to identify and quantify either by light scattering or by microscopic methods.
The manufacturer shall identify the potential hazards associated with each type of particle identified by the risk
assessment.
The manufacturer shall characterize the types, range of sizes, and levels of particulates present in the finished
product. A limit for each type of particle present shall be set and an adequate justification for the limit shall be
documented.
NOTE 2 A method for the determination of particulate counts is contained in annex C.
5.3.10 Refractive index
The refractive index between air and the OVD shall be measured with a refractometer at 25 °C � 2 °C stating at
which wavelength it was determined.
6 Design evaluation
6.1 General
The requirements for evaluation of non-active implants outlined in ISO 14630 shall apply.
6.2 Evaluation of biological safety
6.2.1 General
The procedure for evaluation of biological safety of an OVD shall commence with an assessment of risk, carried out
and documented in accordance with ISO 14971-1. The results of the risk analysis shall determine the tests
required to evaluate the biological safety of the OVD.
For OVDs containing material of animal origin, the risk analysis and management requirements outlined in
EN 12442-1, EN 12442-2 and EN 12442-3 shall apply.
6 © ISO 2001 – All rights reserved

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SIST EN ISO 15798:2002
ISO 15798:2001(E)
For all OVDs the requirements for evaluation of biological safety specified in ISO 10993-1 shall apply, together with
the following particular requirements.
In addition to the biocompatibility tests identified in ISO 10993-1 and by the risk analysis, all of the following tests
shall be considered in the selection of tests to evaluate the biological safety of an OVD.
NOTE 1 Based upon the typical clinical applications in the anterior segment of the eye, OVDs are categorized as “Implant
devices, tissue/bone”. The tests for this and other categories of devices identified in Table 1 of ISO 10993-1 are for guidance
only; they do not represent maximum or minimum test requirements.
NOTE 2 It may be possible to combine biocompatibility tests, thereby reducing the number of animals required for testing.
Two tests can be conducted simultaneously in a single animal provided that the test animal is not subjected to undue pain or
distress.
6.2.2 Intra-ocular implantation test
An intra-ocular implantation site, either in the anterior chamber or vitreous cavity, shall be used for this test. The
general requirements for implantation tests outlined in ISO 10993-6 shall apply. The particular requirements for the
intra-ocular implantation test are outlined in annex A.
If the test OVD causes a significantly greater ocular reaction or inflammatory response than the OVD used as the
control, a risk/benefit evaluation shall be performed.
6.2.3 Bacterial endotoxins test
The OVD shall be evaluated for the presence for bacterial endotoxins using the limulus amoebocyte lysate (LAL)
test, in accordance with the procedure described in USP 24, or equivalent validated test procedure. Any product
that exceeds a bacterial endotoxin limit of 0,5 endotoxin units (EU) per millilitre fails the test.
6.2.4 Evaluation of the intra-ocular pressure increase
A test for IOP shall be performed in accordance with the procedure outlined in anne
...