SIST EN ISO 15798:2013
(Main)Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013)
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013)
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 15798:2013)
Implants ophtalmiques - Dispositifs ophtalmiques viscoélastiques (ISO 15798:2013)
L'ISO 15798:2013 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'?il 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 15798:2013 spécifie 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 15798:2013)
Ta mednarodni standard se uporablja za očesne kirurške pripomočke (razred neaktivnih kirurških vsadkov 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 mednarodni standard 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 15798:2013
01-november-2013
1DGRPHãþD
SIST EN ISO 15798:2010
2þHVQLYVDGNL LPSODQWDWL 2þHVQLNLUXUãNLSULSRPRþNL ,62
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO 15798:2013)
Ophthalmische Implantate - Viskoelastische Substanzen (ISO 15798:2013)
Implants ophtalmiques - Dispositifs ophtalmiques viscoélastiques (ISO 15798:2013)
Ta slovenski standard je istoveten z: EN ISO 15798:2013
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 15798:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 15798:2013
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SIST EN ISO 15798:2013
EUROPEAN STANDARD
EN ISO 15798
NORME EUROPÉENNE
EUROPÄISCHE NORM
September 2013
ICS 11.040.70 Supersedes EN ISO 15798:2010
English Version
Ophthalmic implants - Ophthalmic viscosurgical devices (ISO
15798:2013)
Implants ophtalmiques - Dispositifs ophtalmiques Ophthalmische Implantate - Viskoelastische Substanzen
viscoélastiques (ISO 15798:2013) (ISO 15798:2013)
This European Standard was approved by CEN on 2 April 2013.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 15798:2013: E
worldwide for CEN national Members.
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SIST EN ISO 15798:2013
EN ISO 15798:2013 (E)
Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .4
2
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SIST EN ISO 15798:2013
EN ISO 15798:2013 (E)
Foreword
This document (EN ISO 15798:2013) 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 March 2014, and conflicting national standards shall be withdrawn at
the latest by March 2014.
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 15798:2010.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 15798:2013 has been approved by CEN as EN ISO 15798:2013 without any modification.
3
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SIST EN ISO 15798:2013
EN ISO 15798:2013 (E)
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
This European 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
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC
Clause(s)/sub-clause(s) of Essential Requirements (ERs) Qualifying remarks/Notes
this EN of Directive 93/42/EEC
5, 6.1, 6.2, 7 7.2 Reference to ISO 14971 for risk assessment.
Reference to ISO 22442-1, ISO 22442-2,
ISO 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.
Reference to ISO 17665-1 for sterilization by
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.
6.2 7.3
6.1, 6.2, 7 7.5 Reference to ISO 22442-1, ISO 22442-2,
ISO 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.
Reference to ISO 17665-1 for sterilization by
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
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SIST EN ISO 15798:2013
EN ISO 15798:2013 (E)
Clause(s)/sub-clause(s) of Essential Requirements (ERs) Qualifying remarks/Notes
this EN of Directive 93/42/EEC
7 7.6 Reference to ISO 17665-1 for sterilization by
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.
7 8.1 Reference to ISO 17665-1 for sterilization by
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.
5, 6.1, 6.2 8.2 Reference to ISO 14971 for risk assessment.
Reference to ISO 22442-1, ISO 22442-2,
ISO 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.
7, 8, 10 8.3 Reference to ISO 17665-1 for sterilization by
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.
Reference to ISO 11607-1 and ISO 14630 for
packaging requirements.
7 8.4 Reference to ISO 17665-1 for sterilization by
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.
11 8.7
9 9.1
5 9.2 Reference to ISO 14971 for risk assessment.
Reference to ISO 22442-1, ISO 22442-2,
ISO 22442-3 for material of animal origin.
5
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SIST EN ISO 15798:2013
EN ISO 15798:2013 (E)
Clause(s)/sub-clause(s) of Essential Requirements (ERs) Qualifying remarks/Notes
this EN of Directive 93/42/EEC
11 13 Ophthalmic viscosurgical devices (OVD)
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.
6
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SIST EN ISO 15798:2013
INTERNATIONAL ISO
STANDARD 15798
Third edition
2013-09-15
Ophthalmic implants — Ophthalmic
viscosurgical devices
Implants ophtalmiques — Dispositifs ophtalmiques viscoélastiques
Reference number
ISO 15798:2013(E)
©
ISO 2013
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SIST EN ISO 15798:2013
ISO 15798:2013(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2013
All rights reserved. Unless otherwise specified, 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
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 2013 – All rights reserved
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SIST EN ISO 15798:2013
ISO 15798:2013(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
6 Design evaluation . 6
6.1 General . 6
6.2 Evaluation of biological safety . 6
6.3 Clinical evaluation . 7
7 Sterilization . 9
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 .10
Annex A (normative) Intraocular implantation test .12
Annex B (informative) Patient numbers for clinical investigation of intraocular pressure .15
Bibliography .16
© ISO 2013 – All rights reserved iii
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SIST EN ISO 15798:2013
ISO 15798:2013(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 third edition cancels and replaces the second edition (ISO 15798:2010), which has undergone minor
revision to update the normative references and to revise Table 1.
iv © ISO 2013 – All rights reserved
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SIST EN ISO 15798:2013
INTERNATIONAL STANDARD ISO 15798:2013(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
intraocular 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, Clinical investigation of medical devices for human subjects — Good clinical practice
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 2013 – All rights reserved 1
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SIST EN ISO 15798:2013
ISO 15798:2013(E)
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 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
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 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).
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
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SIST EN ISO 15798:2013
ISO 15798:2013(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, 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 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).
3.13
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
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.
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SIST EN ISO 15798:2013
ISO 15798:2013(E)
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.
−3 −1
NOTE Complex viscosity should, if possible, be determined at frequencies between (10 to 103) Hz (s ).
3
For 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
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SIST EN ISO 15798:2013
ISO 15798:2013(E)
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. O
...
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