SIST EN ISO 15798:2010
(Main)Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010)
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010)
This International Standard is applicable 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. This International Standard specifies 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.
Ophthalmische Implantate - Viskoelastische Substanzen (ISO 15798:2010)
Diese Internationale Norm ist anwendbar auf ophthalmische viskoelastische Substanzen, einer Klasse nichtaktiver
chirurgischer Implantate mit viskosen und/oder viskoelastischen Eigenschaften, die für den Einsatz bei
chirurgischen 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.
Mit Bezug auf die Sicherheit legt diese Internationale Norm Anforderungen für die beabsichtigte Funktion,
Konstruktionsmerkmale, vorklinische und klinische Auswertungen, Sterilisation, Verpackung, Kennzeichnung
und die Bereitstellung von Informationen durch den Hersteller dieser Produkte sowie für Prüfverfahren fest.
Implants ophtalmiques - Dispositifs ophtalmiques viscoélastiques (ISO 15798:2010)
L'ISO 15798:2010 s'applique aux dispositifs ophtalmiques viscoélastiques (OVD), catégorie d'implants chirurgicaux non actifs présentant des propriétés de viscosité et/ou de viscoélasticité, destinés à une utilisation en chirurgie dans le segment antérieur de l'œil humain. Les OVD sont conçus pour créer et maintenir de l'espace, pour protéger les tissus intraoculaires et manipuler les tissus au cours d'interventions chirurgicales.
L'ISO 15798:2010 définit les exigences, en matière de sécurité pour l'utilisation prévue, de conception, d'évaluation préclinique et clinique, de stérilisation, de conditionnement du produit, d'étiquetage du produit et d'informations fournies par le fabricant sur les dispositifs.
Očesni vsadki (implantati) - Očesni kirurški pripomočki (ISO 15798:2010)
Ta mednarodni standard velja za očesne kirurške pripomočke (OVD), razred neaktivnih kirurških vsadkov z viskoznimi in/ali viskoznoelastičnimi lastnostmi, ki so namenjeni uporabi med operacijo prednjega dela človeškega očesa. Očesni kirurški pripomočki so zasnovani tako, da ustvarijo in vzdržujejo prostor za zaščito znotrajočesnih tkiv in premikanje tkiv med operacijo. Ta mednarodni standard določa zahteve v zvezi z varnostjo za predvideno delovanje, lastnosti modela, predklinično in klinično ovrednotenje, sterilizacijo, pakiranje proizvodov, uporabo nalepk na proizvodih in informacije, ki jih priskrbi proizvajalec teh pripomočkov.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 15798:2010
01-junij-2010
1DGRPHãþD
SIST EN ISO 15798:2002
SIST EN ISO 15798:2002/AC:2005
2þHVQLYVDGNL LPSODQWDWL 2þHVQLNLUXUãNLSULSRPRþNL ,62
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2010)
Ophthalmische Implantate - Viskoelastische Substanzen (ISO 15798:2010)
Implants ophtalmiques - Dispositifs ophtalmiques viscoélastiques (ISO 15798:2010)
Ta slovenski standard je istoveten z: EN ISO 15798:2010
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 15798:2010 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN ISO 15798:2010
---------------------- Page: 2 ----------------------
SIST EN ISO 15798:2010
EUROPEAN STANDARD
EN ISO 15798
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2010
ICS 11.040.70 Supersedes EN ISO 15798:2001
English Version
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO
15798:2010)
Implants ophtalmiques - Dispositifs ophtalmiques Ophthalmische Implantate - Viskoelastische Substanzen
viscoélastiques (ISO 15798:2010) (ISO 15798:2010)
This European Standard was approved by CEN on 30 January 2010.
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 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 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland,
Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2010 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15798:2010: E
worldwide for CEN national Members.
---------------------- Page: 3 ----------------------
SIST EN ISO 15798:2010
EN ISO 15798:2010 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this International Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
2
---------------------- Page: 4 ----------------------
SIST EN ISO 15798:2010
EN ISO 15798:2010 (E)
Foreword
This document (EN ISO 15798:2010) has been prepared by Technical Committee ISO/TC 172 "Optics and
photonics" 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 August 2010, and conflicting national standards shall be withdrawn at
the latest by August 2010.
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 15798:2001.
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.
For relationship with EU Directive, 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, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 15798:2010 has been approved by CEN as a EN ISO 15798:2010 without any modification.
3
---------------------- Page: 5 ----------------------
SIST EN ISO 15798:2010
EN ISO 15798:2010 (E)
Annex ZA
(informative)
Relationship between this International Standard and the Essential Requirements of
EU Directive 93/42/EEC
This International 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
International Standard given in Table ZA.1 confers, within the limits of the scope of this International Standard,
a presumption of conformity with the corresponding Essential Requirements of that Directive and associated
EFTA regulations.
Table ZA.1 — Correspondence between this International Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) of Essential Requirements Qualifying remarks/Notes
this International Standard (ERs) of Directive 93/42/EEC
4 Reference to ISO 14630 for general requirements
1, 2, 3
of non-active implants
1, 2, 3, 7.1, 7.2, 8.2, 9.2 Reference to ISO 14971 for risk assessment
5
Reference to ISO 22442-1, ISO 22442-2, ISO
22442-3 for material of animal origin
1, 2, 3, 7.1, 7.2, 7.5, 8.2 Reference to ISO 22442-1, ISO 22442-2, ISO
6.1, 6.2
22442-3 for material of animal origin
Reference to ISO 10993-1 for testing of biological
safety in general
Reference to ISO 10993-9, ISO 10993-16 for
toxicokinetics of degradation products
6.3 6, 6a, 7.3 Reference to ISO 14155 for clinical investigation
in general
1, 2, 7.2, 7.5, 7.6, Reference to ISO 17665-1 for sterilization by
7
8.1, 8.3, 8.4 moist heat
Reference to ISO 11137-1, ISO 11137-2, ISO
11137-3 for sterilization by radiation
Reference to ISO 13408-1 for aseptic processing
Reference to ISO 11135-1 for sterilization with
ethylene oxide
4
---------------------- Page: 6 ----------------------
SIST EN ISO 15798:2010
EN ISO 15798:2010 (E)
Table ZA.1 (continued)
Clause(s)/sub-clause(s) of Essential Requirements Qualifying remarks/Notes
this International Standard (ERs) of Directive 93/42/EEC
8 1, 3, 4, 5, 8.3
9 1, 2, 3, 4, 7.1, 9.1
1, 3, 4, 5, 8.3 Reference to ISO 11607-1 and ISO 14630 for
10
packaging requirements
2, 8.7, 13 Ophthalmic viscosurgical devices (OVD)
11
containing medicinal substances, or human blood
derivatives, have not been considered in the
standard, and at present no such products are
known Custom made OVD are not known
WARNING — Other requirements and other EU Directives may be applicable to the product(s) falling within
the scope of this standard.
5
---------------------- Page: 7 ----------------------
SIST EN ISO 15798:2010
---------------------- Page: 8 ----------------------
SIST EN ISO 15798:2010
INTERNATIONAL ISO
STANDARD 15798
Second edition
2010-02-01
Ophthalmic implants — Ophthalmic
viscosurgical devices
Implants ophtalmiques — Dispositifs ophtalmiques viscoélastiques
Reference number
ISO 15798:2010(E)
©
ISO 2010
---------------------- Page: 9 ----------------------
SIST EN ISO 15798:2010
ISO 15798:2010(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but
shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In
downloading this file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat
accepts no liability in this area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation
parameters were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In
the unlikely event that a problem relating to it is found, please inform the Central Secretariat at the address given below.
COPYRIGHT PROTECTED DOCUMENT
© ISO 2010
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means,
electronic or mechanical, including photocopying and microfilm, without permission in writing from either ISO at the address below or
ISO's member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Published in Switzerland
ii © ISO 2010 – All rights reserved
---------------------- Page: 10 ----------------------
SIST EN ISO 15798:2010
ISO 15798:2010(E)
Contents Page
Foreword .iv
1 Scope.1
2 Normative references.1
3 Terms and definitions .2
4 Intended performance.4
5 Design attributes .4
5.1 General .4
5.2 Characterization of the components .4
5.3 Characterization of the finished product .4
6 Design evaluation.6
6.1 General .6
6.2 Evaluation of biological safety.7
6.3 Clinical evaluation .8
7 Sterilization .10
8 Product stability .10
9 Integrity and performance of the delivery system .10
10 Packaging.10
10.1 Protection from damage during storage and transport .10
10.2 Maintenance of sterility in transit .10
11 Information to be supplied by the manufacturer .11
Annex A (normative) Intraocular implantation test .12
Annex B (informative) Patient numbers for clinical investigation of intra-ocular pressure .15
Bibliography.16
© ISO 2010 – All rights reserved iii
---------------------- Page: 11 ----------------------
SIST EN ISO 15798:2010
ISO 15798:2010(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 15798 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 15798:2001) which has been technically
revised. It also includes the Technical Corrigendum ISO 15798:2001/Cor 1:2003.
iv © ISO 2010 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 15798:2010
INTERNATIONAL STANDARD ISO 15798:2010(E)
Ophthalmic implants — Ophthalmic viscosurgical devices
1 Scope
This International Standard is applicable 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.
This International Standard specifies 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 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 within a risk
management process
ISO 10993-2, Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 10993-6, Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
ISO 10993-9, Biological evaluation of medical devices — Part 9: Framework for identification and
quantification of potential degradation products
ISO 10993-16, Biological evaluation of medical devices — Part 16: Toxicokinetic study design for degradation
products and leachables
ISO 11135-1, Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
ISO 11137-1, Sterilization of health care products — Radiation — Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices
ISO 11137-2, Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose
ISO 11137-3, Sterilization of health care products — Radiation — Part 3: Guidance on dosimetric aspects
ISO 11607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile
barrier systems and packaging systems
ISO 13408-1, Aseptic processing of health care products — Part 1: General requirements
ISO 14155-1, Clinical investigation of medical devices for human subjects — Part 1: General requirements
© ISO 2010 – All rights reserved 1
---------------------- Page: 13 ----------------------
SIST EN ISO 15798:2010
ISO 15798:2010(E)
ISO 14155-2, Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation
plans
ISO 14630, Non-active surgical implants — General requirements
ISO 14971, Medical devices — Application of risk management to medical devices
ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 1: General requirements
ISO 15223-2, Medical devices — Symbols to be used with medical device labels, labelling and information to
be supplied — Part 2: Symbol development, selection and validation
ISO 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for the development,
validation and routine control of a sterilization process for medical devices
ISO 22442-1, Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk
management
ISO 22442-2, Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing,
collection and handling
ISO 22442-3, Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the
elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
EN 980, Symbols for use in the labelling of medical devices
EN 1041, Information supplied by the manufacturer of medical devices
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
absolute complex viscosity
2 2 0,5
Iη* I = [(η′) + (η′′) ]
absolute value of complex viscosity (3.2)
NOTE Absolute complex viscosity is expressed in pascal seconds (Pa⋅s).
3.2
complex viscosity
η*= η′− i ⋅ η′′
viscosity consisting of a viscous η′ and an elastic η′′ component where i is an imaginary number defined by
0,5
i = (−1)
3.3
delivery system
sealed container in which the product is supplied and any additional components provided to introduce the
product into the eye
3.4
elasticity
tendency of a body to return to its original shape after having been deformed
NOTE Elasticity is quantitatively defined as stress (the force generated within the body) divided by strain (the change
in dimensions of the body).
2 © ISO 2010 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 15798:2010
ISO 15798:2010(E)
3.5
lost to follow-up subject
subject for which the final post-operative case report form is overdue and who cannot be contacted despite
extensive written and telephone follow-ups to determine the final clinical outcome
NOTE This category does not include subjects who have died.
3.6
ophthalmic viscosurgical device
OVD
generic term that includes a variety of materials with viscous and/or viscoelastic properties, which 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
3.7
primary container
vial or syringe that contains the OVD
NOTE This container forms part of the delivery system.
3.8
rheologically active component
compound or mixture of compounds in the finished OVD giving the product viscous and/or viscoelastic
properties
3.9
shear viscosity
tendency of a fluid to resist flow 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 Shear viscosity is expressed in pascal seconds (Pa⋅s), traditionally in millipascal seconds (mPa⋅s).
−1
NOTE 3 Shear rate is the velocity gradient in a flowing fluid, expressed in s (per second).
NOTE 4 The shear viscosity divided by the solution density gives the kinematic viscosity, which is a measure of the
viscosity of a fluid influenced by inertia (e.g. gravity).
3.10
sterile barrier
sealed packaging, containing the product and delivery system, which maintains sterility during transport and
storage
3.11
storage container
that part of the packaging intended to protect the device during transport and storage, containing the sterile
barrier
3.12
viscoelasticity
characteristics of a fluid having both viscous and elastic properties
NOTE The viscous modulus, G′′, is frequently called the loss modulus and the elastic modulus, G′, is frequently
called the storage modulus, both moduli are expressed in Pascal (Pa). The moduli can be combined to show the elasticity
of the OVD (see 5.3.5).
3.13
zero shear viscosity
plateau viscosity at vanishing shear rate in a log-log plot of viscosity versus shear rate
NOTE Zero shear viscosity is expressed in pascal seconds (Pa⋅s), traditionally in millipascal seconds (mPa⋅s), or as
a logarithm of the zero shear viscosity.
© ISO 2010 – All rights reserved 3
---------------------- Page: 15 ----------------------
SIST EN ISO 15798:2010
ISO 15798:2010(E)
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) performance in protecting the corneal endothelium.
5 Design attributes
5.1 General
The general requirements for non-active surgical implants outlined in ISO 14630 shall apply.
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.
A risk assessment shall be performed in accordance with ISO 14971.
5.2 Characterization of the components
The manufacturer shall provide a description of each rheologically active component, quantitatively and
qualitatively, in the product.
The raw materials used in the manufacture of the product shall be listed qualitatively, 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 ISO 22442-1,
ISO 22442-2, and ISO 22442-3 shall apply.
If the rheologically active component is a high-molecular mass synthetic polymer, the repeating subunits that
comprise it shall be chemically identified and the linkages between them described. Any cross linking shall
also be described.
5.3 Characterization of the finished product
5.3.1 General
All testing requirements described in 5.3.2 to 5.3.12 shall be performed with the finished, sterilized product.
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 under the conditions expected and
relevant at the time of use, and be reported.
5.3.2 Absolute complex viscosity
The logarithm of the absolute complex viscosity versus the logarithm of the oscillation frequency shall be
graphed to simultaneously demonstrate the resistance to flow and deformation of the OVD formulation. At
very low frequencies the absolute complex viscosity approaches the zero shear viscosity.
4 © ISO 2010 – All rights reserved
---------------------- Page: 16 ----------------------
SIST EN ISO 15798:2010
ISO 15798:2010(E)
−3 3 −1
NOTE Complex viscosity should, if possible, be determined at frequencies between (10 to 10 ) Hz (s ). For
3
products of very high viscosity (>2 ¥ 10 Pa⋅s), frequencies below 0,01 Hz will be required to show the zero shear viscosity.
5.3.3 Chemical and biological contaminants
All chemical or biological contaminants shall be identified and their potential ocular hazard shall be determined
by risk analysis. For raw materials of biological origin, these contaminants can include proteins, nucleic acids
or other biological materials. Contaminants derived from the source materials or from the manufacturing
process, e.g. cross linking agents and antioxidants, shall be identified whenever possible, and their
concentrations in the finished product shall be reported.
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 is required, if the risk analysis deems it necessary.
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.
5.3.4 Concentration
The concentration of each rheologically active component material 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.
5.3.5 Elasticity
The elasticity of the OVD shall be demonstrated at the same frequencies used to determine the complex
viscosity. It shall be demonstrated up to at least 100 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, G′′, and log
elastic, G′, moduli shall be plotted against the log frequency. Data can also be presented as a plot of percent
elasticity against log frequency, for example as 100 × [G′/(G′+G′′)] versus log frequency.
5.3.6 Molecular mass distribution
If the rheologically active component of the OVD is a polymer, the mass average relative molecular mass shall
be reported.
It is recognized that many OVDs contain high molecular mass polymers that are polydisperse 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. Standard methods shall be used wherever possible.
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 a cryoscopic osmometer under standard conditions.
5.3.8 Particulates
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 OVDs containing synthetic polymers are likely to be at significantly higher risk of formation of microgels, which
are difficult to identify and quantify.
© ISO 2010 – All rights reserved 5
---------------------- Page: 17 ----------------------
SIST EN ISO 15798:2010
ISO 15798:2010(E)
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 using a
validated method.
A limit for the overall number of particles (e.g., W 10 µm and W 25 µm) present, and a limit for each type of
particle identified by the risk analysis as a potential ocular hazard at the levels allowed by the overall particle
specification, shall be set and an adequate justification for the limits shall be documented.
5.3.9 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.
NOTE The pH meter should be fitted with an electrode suitable for high viscosity solutions. The pH of the product
should be close to that of the aqueous humour (pH 7,38) in order to prevent damage to the corneal endothelial cells. In
vi
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.