SIST EN ISO 15798:2022
(Main)Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2022)
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2022)
This document is applicable to ophthalmic viscosurgical devices (OVDs), a class of surgical invasive
medical devices 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
intraocular tissues and to manipulate tissues during surgery.
This document 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 15798:2022)
Dieses Dokument ist anwendbar auf ophthalmische viskoelastische Substanzen, einer Klasse chirurgischer invasiver Medizinprodukte mit viskosen und/oder viskoelastischen Eigenschaften, die für den Einsatz bei chirurgischen Eingriffen im Vorderabschnitt des menschlichen Auges bestimmt sind. Viskoelastische Sub-stanzen 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 dieses Dokument 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 15798:2022)
Le présent document s'applique aux dispositifs ophtalmiques viscoélastiques (OVD), une catégorie de dispositifs médicaux invasifs de type chirurgical 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.
Le présent document spécifie les exigences en matière de sécurité pour l'utilisation prévue, les caractéristiques de conception, l'évaluation préclinique et clinique, la stérilisation, l'emballage du produit, l'étiquetage du produit et les informations fournies par le fabricant de ces dispositifs.
Očesni vsadki (implantati) - Očesni kirurški pripomočki (ISO 15798:2022)
Ta dokument se uporablja za očesne kirurške pripomočke (OVD) (razred kirurško invazivnih medicinskih pripomočkov z viskoznimi in/ali viskoznoelastičnimi lastnostmi), ki so namenjeni za uporabo med operacijo v frontalnem segmentu človeškega očesa. Očesni kirurški pripomočki so namenjeni ustvarjanju in vzdrževanju prostora, zaščiti tkiv znotraj očesa in manipulaciji tkiva med operacijo. Ta dokument določa zahteve glede varnosti za predvidene lastnosti, atribute načrtovanja, predklinično in klinično vrednotenje, sterilizacijo, pakiranje izdelkov, označevanje izdelkov in informacije, ki jih dobavlja proizvajalec teh pripomočkov.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 15798:2022
01-april-2022
Nadomešča:
SIST EN ISO 15798:2013
SIST EN ISO 15798:2013/A1:2017
Očesni vsadki (implantati) - Očesni kirurški pripomočki (ISO 15798:2022)
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2022)
Ophthalmische Implantate - Viskoelastische Substanzen (ISO 15798:2022)
Implants ophtalmiques - Dispositifs ophtalmiques viscoélastiques (ISO 15798:2022)
Ta slovenski standard je istoveten z: EN ISO 15798:2022
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 15798:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 15798:2022
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SIST EN ISO 15798:2022
EN ISO 15798
EUROPEAN STANDARD
NORME EUROPÉENNE
February 2022
EUROPÄISCHE NORM
ICS 11.040.70 Supersedes EN ISO 15798:2013, EN ISO
15798:2013/A1:2017
English Version
Ophthalmic implants - Ophthalmic viscosurgical devices
(ISO 15798:2022)
Implants ophtalmiques - Dispositifs ophtalmiques Ophthalmische Implantate - Viskoelastische
viscoélastiques (ISO 15798:2022) Substanzen (ISO 15798:2022)
This European Standard was approved by CEN on 17 January 2022.
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-CENELEC 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-CENELEC 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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15798:2022 E
worldwide for CEN national Members.
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SIST EN ISO 15798:2022
EN ISO 15798:2022 (E)
Contents Page
European foreword . 3
2
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SIST EN ISO 15798:2022
EN ISO 15798:2022 (E)
European foreword
This document (EN ISO 15798:2022) 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 2022, and conflicting national standards shall
be withdrawn at the latest by August 2022.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 15798:2013.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 15798:2022 has been approved by CEN as EN ISO 15798:2022 without any modification.
3
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SIST EN ISO 15798:2022
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SIST EN ISO 15798:2022
INTERNATIONAL ISO
STANDARD 15798
Fourth edition
2022-01
Ophthalmic implants — Ophthalmic
viscosurgical devices
Implants ophtalmiques — Dispositifs ophtalmiques viscoélastiques
Reference number
ISO 15798:2022(E)
© ISO 2022
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SIST EN ISO 15798:2022
ISO 15798:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
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SIST EN ISO 15798:2022
ISO 15798:2022(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
5.1 General . 4
5.2 Characterization of the components . 4
5.3 Characterization of the finished product. 4
5.3.1 General . 4
5.3.2 Absolute complex viscosity . 5
5.3.3 Chemical and biological contaminants . 5
5.3.4 Concentration . 5
5.3.5 Elasticity . 5
5.3.6 Molecular mass distribution . 5
5.3.7 Osmolality . 5
5.3.8 Particulates . 6
5.3.9 pH . 6
5.3.10 Refractive index . 6
5.3.11 Shear viscosity . 6
5.3.12 Spectral transmittance . . 6
5.4 Usability . 7
6 Design evaluation . 7
6.1 General . 7
6.2 Evaluation of biological safety . 7
6.2.1 General . 7
6.2.2 Bacterial endotoxins test . 8
6.2.3 Clearance of residual OVD from the anterior chamber . 8
6.2.4 Degradation and toxicokinetics . 8
6.2.5 Evaluation of inflammation and intraocular pressure . 8
6.3 Clinical evaluation . 8
6.3.1 General . 8
6.3.2 Clinical investigation design . 9
6.3.3 Corneal endothelial cell density . 9
6.3.4 Postoperative inflammation . 9
6.3.5 Post-operative intraocular pressure change . 10
6.3.6 Adverse events . 10
7 Sterilization .10
8 Product stability .11
9 Integrity and performance of the delivery system .11
10 Packaging.11
10.1 Protection from damage during storage and transport. 11
10.2 Maintenance of sterility in transit . 11
11 Information to be supplied by the manufacturer .11
Annex A (normative) Intraocular implantation test .13
Annex B (informative) Patient numbers for clinical investigation of intraocular pressure .16
Annex C (informative) Analyses of OVD clinical data .17
Bibliography .19
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SIST EN ISO 15798:2022
ISO 15798:2022(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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to
the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee
SC 7, Ophthalmic optics and instruments, in collaboration with the European Committee for
Standardization (CEN) Technical Committee CEN/TC 170, Ophthalmic optics, in accordance with the
Agreement on technical cooperation between ISO and CEN (Vienna Agreement).
This fourth edition cancels and replaces the third edition (ISO 15798:2013 and its Amendment,
ISO 15798:2013/Amd.1:2017), which has been technically revised.
The main changes compared to the previous edition are as follows:
a) Inclusion of applicable sections from ISO 14630 throughout the document, but removal of any
reference to that standard. It was further clarified that ophthalmic viscosurgical devices (OVD) are
no implant by their intended use but are likely to share some of the risks related to non-active
implants. Therefore, the following clauses and subclauses have been revised: Clauses 4 and 5, 6.1,
6.2.1, Clause 7. A new subclause 5.4 has been added.
b) minor clarifications in Clause 3 (3.3, 3.4) and addition of term surgical invasive medical device;
c) clarification in Clause 4 that a recommended removal procedure shall enable removal of the OVD as
completely as possible;
d) revised wording in 5.2 to align with defined terminology from Clause 3;
e) revised note in 5.3.2: narrowed recommended measuring range;
f) revised note in 5.3.8: more accurate description of the risk;
g) clarification that control OVD for the intraocular implantation test and the clinical investigation
shall be the same in both studies; therefore, the following subclauses have been revised: 6.1, 6.2.5,
6.3.2, and Annex A;
h) revised wording in 6.2.2 of this document to include ISO 15798:2013/Amd.1:2017 and guidance on
standard LAL-test;
iv
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SIST EN ISO 15798:2022
ISO 15798:2022(E)
i) revised wording in 6.2.3 to address the potential risk of interaction of the OVD with fluorescence or
radioisotope labelling;
j) revised 6.3 to clarify requirement of a clinical evaluation, clarification of the clinical investigation
protocol, revision of the clinical investigation design, and additional standardization for evaluation
and reporting of result from the clinical investigation;
k) inclusion of reference to ISO 10993-7 for acceptable levels of ethylene oxide and ethylene
chlorohydrin in Clause 7;
l) packaging integrity has been specifically included into the scope of product stability Clause 8; in
addition, reference to ISO 14971 has been included into this clause;
m) “Do not use if sterile barrier is breached” has been aligned with the recommended wording from
ISO 15223-1 “Do not use if package is damaged”; in addition, molecular mass distribution has been
removed from the list of information to be supplied by the manufacturer in Table 1;
n) major revision of Annex A;
o) correction of a typo in the formula for calculating the minimum number of evaluable patients per
treatment group in Annex B.
p) Addition of new informative Annex C on analyses of OVD clinical data.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
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SIST EN ISO 15798:2022
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SIST EN ISO 15798:2022
INTERNATIONAL STANDARD ISO 15798:2022(E)
Ophthalmic implants — Ophthalmic viscosurgical devices
1 Scope
This document is applicable to ophthalmic viscosurgical devices (OVDs), a class of surgical invasive
medical devices 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
intraocular tissues and to manipulate tissues during surgery.
This document 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 documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 10993-6, Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
ISO 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
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, Sterilization of health-care products — Ethylene oxide — Requirements for the 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 of
development, validation and routine control
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, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14971, Medical devices — Application of risk management to medical devices
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
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SIST EN ISO 15798:2022
ISO 15798:2022(E)
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 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.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
absolute complex viscosity
05,
* 22
′′′
ηη= () +()η
absolute value of complex viscosity (3.2)
Note 1 to entry: 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
0,5
by i = (−1)
3.3
delivery system
primary container in which the product is supplied and any additional components provided to
introduce the product into the eye
3.4
elasticity
G ’= σ /ε ·cosδ
0 0
tendency of a body to return to its original shape after having been deformed
Note 1 to entry: Elasticity is quantitatively defined as stress (the force generated within the body) divided by
strain (the change in dimensions of the body) multiplied by cosine of the phase lag between stress and strain.
Note 2 to entry: Elasticity is expressed in pascal (Pa).
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 1 to entry: 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 intraocular tissues and to manipulate tissues during
surgery in the anterior segment of the human eye
2
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SIST EN ISO 15798:2022
ISO 15798:2022(E)
3.7
primary container
vial or syringe that contains the OVD
Note 1 to entry: 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 to entry: Quantitatively, shear viscosity is the quotient of shear stress divided by shear rate in steady
shear flow.
Note 2 to entry: Shear viscosity is expressed in pascal seconds (Pa·s), traditionally in millipascal seconds (mPa·s).
−1
Note 3 to entry: Shear rate is the velocity gradient in a flowing fluid, expressed in s (per second).
Note 4 to entry: 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 (3.3), 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
surgical invasive medical device
invasive device which penetrates inside the body through the surface of the body with the aid or in the
context of a surgical operation
3.13
viscoelasticity
characteristics of a fluid having both viscous and elastic properties
Note 1 to entry: 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).
3.14
zero shear viscosity
plateau viscosity at vanishing shear rate in a log-log plot of viscosity versus shear rate
Note 1 to entry: 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.
4 Intended performance
OVDs are surgically invasive medical devices. They shall be compatible with the internal ocular
environment. Intended performance is primarily provided for by their viscous and/or viscoelastic
properties, which are designed to create and maintain space, to protect intraocular tissues and to
manipulate tissues during surgery in the anterior segment of the human eye. OVDs are used intra-
3
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SIST EN ISO 15798:2022
ISO 15798:2022(E)
operatively and intended to be removed at the end of surgery. The manufacturer shall describe any
performance characteristic to be provided for by the OVD. In addition, the manufacturer shall
particularly describe the intended way of application, the performance in protecting the corneal
endothelium, the intended time that the OVD resides in the anterior chamber of the eye, and the method
for removal. This method shall enable removal of the OVD as completely as possible.
In addition, the manufacturer shall describe and document the functional characteristics of the OVD in
terms of its:
a) chemical composition;
b) rheological properties.
5 Design attributes
5.1 General
The following subclauses are listing specific design attributes to be met for the intended performance.
Tests described therein are intended to apply when qualifying materials but not necessarily apply as a
routine quality assurance/control programme.
A risk assessment shall be performed in accordance with ISO 14971. OVD design attributes shall be
documented. Where any of the design attributes is not considered to be relevant, the reason shall be
documented and justified.
5.2 Characterization of the components
The manufacturer shall provide a description of the rheologically active component(s).
The manufacturer shall provide a description of each compound belonging to the rheologically active
component(s).
The raw materials use
...
SLOVENSKI STANDARD
oSIST prEN ISO 15798:2021
01-februar-2021
Očesni vsadki (implantati) - Očesni kirurški pripomočki (ISO/DIS 15798:2020)
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO/DIS 15798:2020)
Ophthalmische Implantate - Viskoelastische Substanzen (ISO/DIS 15798:2020)
Implants ophtalmiques - Dispositifs ophtalmiques viscoélastiques (ISO/DIS 15798:2020)
Ta slovenski standard je istoveten z: prEN ISO 15798
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
oSIST prEN ISO 15798:2021 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN ISO 15798:2021
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oSIST prEN ISO 15798:2021
DRAFT INTERNATIONAL STANDARD
ISO/DIS 15798
ISO/TC 172/SC 7 Secretariat: DIN
Voting begins on: Voting terminates on:
2020-12-28 2021-03-22
Ophthalmic implants — Ophthalmic viscosurgical devices
Implants ophtalmiques — Dispositifs ophtalmiques viscoélastiques
ICS: 11.040.70
THIS DOCUMENT IS A DRAFT CIRCULATED
This document is circulated as received from the committee secretariat.
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
ISO/CEN PARALLEL PROCESSING
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 15798:2020(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
©
PROVIDE SUPPORTING DOCUMENTATION. ISO 2020
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oSIST prEN ISO 15798:2021
ISO/DIS 15798:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
on the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
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oSIST prEN ISO 15798:2021
ISO/DIS 15798:2020(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 . 5
5.3.1 General. 5
5.3.2 Absolute complex viscosity . 5
5.3.3 Chemical and biological contaminants . 5
5.3.4 Concentration . 5
5.3.5 Elasticity . 5
5.3.6 Molecular mass distribution . 5
5.3.7 Osmolality . 6
5.3.8 Particulates . 6
5.3.9 pH . 6
5.3.10 Refractive index . 6
5.3.11 Shear viscosity . 6
5.3.12 Spectral transmittance . . 7
5.4 Usability . 7
6 Design evaluation . 7
6.1 General . 7
6.2 E valuation of biological safety . 7
6.2.1 General. 7
6.2.2 Bacterial endotoxins test . 8
6.2.3 Clearance of residual OVD from the anterior chamber . 8
6.2.4 Degradation and toxicokinetics . 8
6.2.5 Evaluation of inflammation and intraocular pressure . 8
6.3 Clinical evaluation . 9
6.3.1 General. 9
6.3.2 Clinical investigation design . 9
6.3.3 Corneal endothelial cell density .10
6.3.4 Postoperative inflammation .10
6.3.5 Post-operative intraocular pressure change .10
6.3.6 Adverse events .10
7 Sterilization .11
8 Product stability .11
9 Integrity and performance of the delivery system .11
10 Packaging .11
10.1 Protection from damage during storage and transport.11
10.2 Maintenance of sterility in transit .11
11 Information to be supplied by the manufacturer .12
Annex A (normative) Intraocular implantation test .13
Annex B (informative) Patient numbers for clinical investigation of intraocular pressure .16
Bibliography .17
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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.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).
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. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www .iso .org/ patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see www .iso .org/
iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee
SC 7, Ophthalmic optics and instruments.
This fourth edition cancels and replaces the third edition (ISO 15798:2013 and its Amendment,
ISO 15798:2013/Amd.1:2017), which has been technically revised.
The main changes compared to the previous edition are as follows:
a) Inclusion of applicable sections from ISO 14630 throughout the document, but removal of any
reference to that standard. It was further clarified that OVDs are no implant by their intended use but
are likely to share some of the risks related to non-active implants. Therefore, the following clauses
and sub-clauses have been revised: 4, 5, 6.1, 6.2.1, 7. A new sub-clause 5.4 Usability has been added.
b) minor clarifications in clause 3 Terms and definitions (3.3, 3.4) and addition of term surgical invasive
medical device;
c) clarification in clause 4 that a recommended removal procedure shall enable removal of the OVD as
completely as possible;
d) revised wording in sub-clause 5.2 to align with defined terminology from clause 3;
e) revised note in sub-clause 5.3.2: narrowed recommended measuring range;
f) revised note in sub-clause 5.3.8: more accurate description of the risk;
g) clarification that control OVD for the intraocular implantation test and the clinical investigation
shall be the same in both studies; therefore, the following sub-clauses have been revised: 6.1, 6.2.5,
6.3.2, and Annex A;
h) revised wording in sub-clause 6.2.2 to include ISO 15798:2013/Amd.1:2017 and guidance on
standard LAL-test;
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i) revised wording in sub-clause 6.2.3 to address the potential risk of interaction of the OVD with
fluorescence or radioisotope labelling;
j) revised sub-clause 6.3 to clarify requirement of a clinical evaluation, clarification of the clinical
investigation protocol, revision of the clinical investigation design, and additional standardization
for evaluation and reporting of result from the clinical investigation;
k) inclusion of reference to ISO 10993-7 for acceptable levels of ethylene oxide and ethylene
chlorohydrin in clause 7;
l) packaging integrity has been specifically included into the scope of product stability; in addition,
reference to ISO 14971 has been included into this section;
m) “Do not use if sterile barrier is breached” has been aligned with the recommended wording from
ISO 15223-1 “Do not use if package is damaged”; in addition, molecular mass distribution has been
removed from the list of information to be supplied by the manufacturer;
n) major revision of Annex A;
o) correction of a typo in the formula for calculating the minimum number of evaluable patients per
treatment group in Annex B.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www .iso .org/ members .html.
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DRAFT INTERNATIONAL STANDARD ISO/DIS 15798:2020(E)
Ophthalmic implants — Ophthalmic viscosurgical devices
1 Scope
This document is applicable to ophthalmic viscosurgical devices (OVDs), a class of surgical invasive
medical devices 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
intraocular tissues and to manipulate tissues during surgery.
This document 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 documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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 8601, Data elements and interchange formats - Information interchange - Representation of dates
and times
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 10993-7, Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals
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, Sterilization of health-care products — Ethylene oxide — Requirements for the 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 of
development, validation and routine control
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, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14971, Medical devices — Application of risk management to medical devices
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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.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
absolute complex viscosity
2 2 0,5
Iη* I = [(η′) + (η′′) ]
absolute value of complex viscosity (3.2)
Note 1 to entry: 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
0,5
by i = (−1)
3.3
delivery system
primary container in which the product is supplied, and any additional components provided to
introduce the product into the eye
3.4
elasticity
G’=σ/ε*cosδ
0 0
tendency of a body to return to its original shape after having been deformed
Note 1 to entry: Elasticity is quantitatively defined as stress (the force generated within the body) divided by
strain (the change in dimensions of the body) multiplied by cosine of the phase lag between stress and strain.
Note 2 to entry: Elasticity is expressed in pascal (Pa).
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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 1 to entry: 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 intraocular 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 1 to entry: 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 to entry: Quantitatively, shear viscosity is the quotient of shear stress divided by shear rate in steady
shear flow.
Note 2 to entry: Shear viscosity is expressed in pascal seconds (Pa·s), traditionally in millipascal seconds (mPa·s).
−1
Note 3 to entry: Shear rate is the velocity gradient in a flowing fluid, expressed in s (per second).
Note 4 to entry: 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
surgical invasive medical device
invasive device which penetrates inside the body through the surface of the body with the aid or in the
context of a surgical operation
3.13
viscoelasticity
characteristics of a fluid having both viscous and elastic properties
Note 1 to entry: 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).
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3.14
zero shear viscosity
plateau viscosity at vanishing shear rate in a log-log plot of viscosity versus shear rate
Note 1 to entry: 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.
4 Intended performance
OVDs are surgically invasive medical devices. They must be compatible with the internal ocular
environment. Intended performance is primarily provided for by their viscous and/or viscoelastic
properties, which are designed to create and maintain space, to protect intraocular tissues and to
manipulate tissues during surgery in the anterior segment of the human eye. OVDs are used intra-
operatively and intended to be removed at the end of surgery. The manufacturer shall describe any
performance characteristic to be provided for by the OVD. In addition, the manufacturer shall
particularly describe the intended way of application, the performance in protecting the corneal
endothelium, the intended time that the OVD resides in the anterior chamber of the eye, and the method
for removal, whereas this method shall enable removal of the OVD as completely as possible.
In addition, the manufacturer shall describe and document the functional characteristics of the OVD in
terms of its
a) chemical composition;
b) rheological properties.
5 Design attributes
5.1 General
The following subclauses of this section are listing specific design attributes to be met for the intended
performance. Tests described therein are intended to apply when qualifying materials but not
necessarily apply as a routine quality assurance/control programme.
A risk assessment shall be performed in accordance with ISO 14971. OVD design attributes shall be
documented. Where any of the design attributes is not considered to be relevant, the reason shall be
documented and justified.
5.2 Characterization of the components
The manufacturer shall provide a description of the rheologically active component(s).
The manufacturer shall provide a description of each compound belonging to the rheologically active
component(s).
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 or one of its compounds 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 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.
The purity of water used shall be water for injection.
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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.
−1
NOTE Complex viscosity should, if possible, be determined at frequencies between (0,01 to 100) 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, viruses and other transmissible agents (unclassified pathogenic entities, prions
and similar entities, or other biological materials. Contaminants derived from the source materials or
from the manufacturing process (including sterilization), e.g. cross-linking agents and antioxidants,
shall be identified whenever possible, and their concentrations in the finished product shall be reported.
Assessment of contaminants shall consider degradation characteristics of active component, including
interactions with laser light, ultrasound energy, or other high energy sources likely to be used along
with the OVD during surgery, and leachables/extractables from the primary container.
Contaminants shall be determined using standard analytical methods, when available, and all methods
shall be described. Limits for identified conta
...
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