SIST EN ISO 16672:2015
(Main)Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)
Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)
This International Standard applies to ocular endotamponades (OE), a group of non-solid implants used
in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina.
With regard to the safety and efficacy of OE, this International Standard specifies requirements for
their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product
packaging, product labelling and the information supplied by the manufacturer.
Ophthalmische Implantate - Okulare Endotamponaden (ISO 16672:2015)
Diese Internationale Norm befasst sich mit okularen Endotamponaden (OE), einer Klasse nicht-solider Implantate, die in der Ophthalmologie zur Glättung und zum Wiederanlegen einer abgelösten Netzhaut an die Aderhaut oder als Netzhauttamponade verwendet werden.
Mit Bezug auf die Sicherheit und Effektivität von OE legt diese Internationale Norm Anforderungen für die beabsichtigte Funktion, Konstruktionsmerkmale, vorklinische und klinische Prüfungen, Sterilisation, Verpackung, Kennzeichnung und die Bereitstellung von Informationen durch den Hersteller fest.
Implants ophtalmiques - Produits de tamponnement endoculaires (ISO 16672:2015)
L'ISO 16672:2015 s'applique aux produits de tamponnement endoculaires, un groupe d'implants non solides utilisés en ophtalmologie pour mettre à plat et repositionner une rétine décollée sur la choroïde, ou pour tamponner la rétine.
Tout en tenant compte de la sécurité et de l'efficacité des produits de tamponnement endoculaires, l'ISO 16672:2015 définit les exigences relatives à leurs performances attendues, à leurs données de conception, à une évaluation préclinique et clinique, à la stérilisation, au conditionnement du produit, à son étiquetage et aux informations fournies par le fabricant.
Očesni vsadki (implantati) - Sredstva za notranjo očesno tamponado (ISO 16672:2015)
Ta mednarodni standard se uporablja za sredstva za notranjo očesno tamponado (OE), tj. skupino vsadkov, ki niso v trdnem stanju, ki se uporabljajo v oftalmologiji za izravnavo in nameščanje mrežnice na horoideo, ali za tamponado mrežnice. Ta mednarodni standard določa zahteve glede varnosti in učinkovitosti sredstva za notranjo očesno tamponado za predvidene lastnosti, atribute načrtovanja, predklinično in klinično ocenjevanje, sterilizacijo, pakiranje izdelkov, označevanje izdelkov in informacije, ki jih dobavlja proizvajalec.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 16672:2015
01-oktober-2015
1DGRPHãþD
SIST EN ISO 16672:2003
2þHVQLYVDGNL LPSODQWDWL 6UHGVWYD]DQRWUDQMRRþHVQRWDPSRQDGR ,62
Ophthalmic implants - Ocular endotamponades (ISO 16672:2015)
Ophthalmische Implantate - Okulare Endotamponaden (ISO 16672:2015)
Implants ophtalmiques - Produits de tamponnement endoculaires (ISO 16672:2015)
Ta slovenski standard je istoveten z: EN ISO 16672:2015
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 16672:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 16672:2015
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SIST EN ISO 16672:2015
EUROPEAN STANDARD
EN ISO 16672
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2015
ICS 11.040.70 Supersedes EN ISO 16672:2003
English Version
Ophthalmic implants - Ocular endotamponades (ISO
16672:2015)
Implants ophtalmiques - Produits de tamponnement Ophthalmische Implantate - Okulare Endotamponaden (ISO
endoculaires (ISO 16672:2015) 16672:2015)
This European Standard was approved by CEN on 7 May 2015.
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
© 2015 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16672:2015 E
worldwide for CEN national Members.
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SIST EN ISO 16672:2015
EN ISO 16672:2015 (E)
Contents Page
European foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .5
2
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SIST EN ISO 16672:2015
EN ISO 16672:2015 (E)
European foreword
This document (EN ISO 16672:2015) 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 February 2016, and conflicting national standards shall be withdrawn
at the latest by February 2016.
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 16672:2003.
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(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
The following referenced documents are indispensable for the application of this document. For undated
references, the latest edition of the referenced document (including any amendments) applies. For dated
references, only the edition cited applies. However, for any use of this standard ‘within the meaning of Annex
ZA’, the user should always check that any referenced document has not been superseded and that its
relevant contents can still be considered the generally acknowledged state-of-art.
When an IEC or ISO standard is referred to in the ISO standard text, this shall be understood as a normative
reference to the corresponding EN standard, if available, and otherwise to the dated version of the ISO or IEC
standard, as listed below.
NOTE The way in which these referenced documents are cited in normative requirements determines the extent (in
whole or in part) to which they apply.
Table — Correlation between normative references and dated EN and ISO standards
Normative references Equivalent dated standard
as listed in Clause 2 of the ISO
EN ISO
standard
ISO 10993-1:2009 EN ISO 10993-1:2009 + AC:2010 ISO 10993-1:2009 + Cor 1:2010
ISO 10993-2:2006 EN ISO 10993-2:2006 ISO 10993-2:2006
ISO 11607-1:2006 EN ISO 11607-1:2009 + A1:2014 ISO 11607-1:2006 + Amd 1:2014
ISO 13408-1:2008 + Amd 1:2013 EN ISO 13408-1:2011 + A1:2013 ISO 13408-1:2008 + Amd 1:2013
ISO 14155:2011 EN ISO 14155:2011 + AC:2011 ISO 14155:2011 + Cor 1:2011
ISO 14630:2012 EN ISO 14630:2012 ISO 14630:2012
ISO 14971:2007 EN ISO 14971:2012 ISO 14971:2007
ISO 15223-1:2012 EN ISO 15223-1:2012 ISO 15223-1:2012
ISO 22442-1:2007 EN ISO 22442-1:2007 ISO 22442-1:2007
EN 1041:2008 + A1:2013 EN 1041:2008 + A1:2013 —
3
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SIST EN ISO 16672:2015
EN ISO 16672:2015 (E)
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 16672:2015 has been approved by CEN as EN ISO 16672:2015 without any modification.
4
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SIST EN ISO 16672:2015
EN ISO 16672:2015 (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 the Essential Requirements of
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 normative 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.
NOTE 1 Where a reference from a clause of this standard to the risk management process is made, the risk
management process needs to be in compliance with Directive 93/42/EEC, as amended by 2007/47/EC. This means that
risks have to be reduced ‘as far as possible’, ‘to a minimum’, ‘to the lowest possible level’, ‘minimized’ or ‘removed’,
according to the wording of the corresponding essential requirement.
NOTE 2 The manufacturer’s policy for determining acceptable risk must be in compliance with essential requirements
1, 2, 5, 6, 7, 8, 9, 11 and 12 of the Directive.
NOTE 3 This Annex ZA is based on normative references according to the table of references in the European
foreword, replacing the references in the core text.
NOTE 4 When an Essential Requirement does not appear in Table ZA.1, it means that it is not addressed by this
European Standard.
Table ZA.1 — Correspondence between this European Standard and Directive 93/42/EEC
Essential Requirements
Clause(s)/subclause(s) of this Qualifying
(ERs) of Directive
European Standard remarks/notes
93/42/EEC
5.2 & 5.11, 7.2
7 in respect of EO contamination
only.
6.3 7.3
7 7.6
7 8.1
5.2, 6.2.1 8.2
10, 8.3
11 in respect of exposure to
environmental elements
7 in respect of EO sterilization 8.4
11 13.1
11 13.2
11 13.3 a), b), c), d),
e), f), i), j), k), m)
5
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SIST EN ISO 16672:2015
EN ISO 16672:2015 (E)
11 13.4
11 13.6 a), b), e), f), g)
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 16672:2015
INTERNATIONAL ISO
STANDARD 16672
Second edition
2015-08-01
Ophthalmic implants — Ocular
endotamponades
Implants ophtalmiques — Produits de tamponnement endoculaires
Reference number
ISO 16672:2015(E)
©
ISO 2015
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SIST EN ISO 16672:2015
ISO 16672:2015(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2015, Published in Switzerland
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
Ch. de Blandonnet 8 • CP 401
CH-1214 Vernier, Geneva, Switzerland
Tel. +41 22 749 01 11
Fax +41 22 749 09 47
copyright@iso.org
www.iso.org
ii © ISO 2015 – All rights reserved
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SIST EN ISO 16672:2015
ISO 16672:2015(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Intended performance . 3
5 Design attributes . 3
5.1 General . 3
5.2 Chemical and biological contaminants . 3
5.3 Chemical description . 3
5.4 Concentration of the components . 4
5.5 Density . 4
5.6 Gaseous expansion . 4
5.7 Interfacial tension . 4
5.8 Kinematic viscosity . 4
5.9 Dynamic viscosity . 4
5.10 Molecular mass distribution . 4
5.11 Particulates. 4
5.12 Refractive index . 4
5.13 Spectral transmittance . 5
5.14 Surface tension . 5
5.15 Vapour pressure . 5
6 Design evaluation . 5
6.1 General . 5
6.2 Evaluation of biological safety . 5
6.2.1 General. 5
6.2.2 Bacterial endotoxins test . 5
6.2.3 Intraocular implantation test . 5
6.2.4 Ethylene oxide . 6
6.3 Clinical investigation . 6
7 Sterilization . 6
8 Product stability . 7
9 Integrity and performance of the delivery system . 7
10 Packaging . 7
10.1 Protection from damage during storage and transport. 7
10.2 Maintenance of sterility in transit . 7
11 Information supplied by the manufacturer . 7
Annex A (normative) Intraocular implantation test . 9
Annex B (informative) Clinical investigation .10
Bibliography .13
© ISO 2015 – All rights reserved iii
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SIST EN ISO 16672:2015
ISO 16672:2015(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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical
Barriers to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 172, Optics and photonics, Subcommittee SC 7,
Ophthalmic optics and instruments.
This second edition cancels and replaces the first edition (ISO 16672:2003), which has been
technically revised.
iv © ISO 2015 – All rights reserved
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SIST EN ISO 16672:2015
INTERNATIONAL STANDARD ISO 16672:2015(E)
Ophthalmic implants — Ocular endotamponades
1 Scope
This International Standard applies to ocular endotamponades (OE), a group of non-solid implants used
in ophthalmology to flatten and position a detached retina onto the choroid, or to tamponade the retina.
With regard to the safety and efficacy of OE, this International Standard specifies requirements for
their intended performance, design attributes, pre-clinical and clinical evaluation, sterilization, product
packaging, product labelling and the information supplied by the manufacturer.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 10993-1:2009, Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk
management process
ISO 10993-2:2006, Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 10993-6:2007, Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
ISO 11135-1:2007, Sterilization of health care products — Ethylene oxide — Part 1: Requirements for
development, validation and routine control of a sterilization process for medical devices
ISO 11137-1:2006 + Amd.1:2013, Sterilization of health care products — Radiation — Part 1: Requirements
for development, validation and routine control of a sterilization process for medical devices
ISO 11607-1:2006, Packaging for terminally sterilized medical devices — Part 1: Requirements for
materials, sterile barrier systems and packaging systems
ISO 13408-1:2008 + Amd.1:2013, Aseptic processing of health care products — Part 1: General requirements
ISO 14155:2011, Clinical investigation of medical devices for human subjects — Good clinical practice
ISO 14630:2012, Non-active surgical implants — General requirements
ISO 14971:2007, Medical devices — Application of risk management to medical devices
ISO 15223-1:2012, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied — Part 1: General requirements
ISO 17665-1:2006, 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 20857:2010, Sterilization of health care products — Dry heat — Requirements for the development,
validation and routine control of a sterilization process for medical devices
EN 1041:2008 + A1:2013, 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 2015 – All rights reserved 1
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SIST EN ISO 16672:2015
ISO 16672:2015(E)
3.1
delivery system
sealed container in which the product is supplied and any additional component provided to introduce
the product into the eye
3.2
dynamic viscosity
quotient of the part of the stress in phase with the rate of strain divided by the rate of strain under
sinusoidal conditions
Note 1 to entry: The dynamic viscosity is expressed in pascal seconds (Pa⋅s).
3.3
interfacial tension
tension against liquids
Note 1 to entry: The interfacial tension is expressed in newton per metre (N/m).
3.4
kinematic viscosity
quotient of the dynamic viscosity with the gravity
2
Note 1 to entry: The kinematic viscosity is expressed in square metres per second (m /s).
3.5
non-solid implants
tamponade media such as gases, liquids, or gels
3.6
ocular endotamponade
OE
non-solid implant used in ophthalmology to flatten and position a detached retina onto the choroid, or
to tamponade the retina
3.7
primary container
container providing mechanical and microbiological protection of the content
3.8
sterile barrier system
minimum package that prevents ingress of microorganisms and allows aseptic presentation of the
product at the point of use
[SOURCE: ISO/TS 11139:2006, 2.44]
3.9
storage container
part of the packaging intended to protect the device during transport and storage, containing the
sterile barrier
3.10
surface tension
tension against air
Note 1 to entry: Surface tension is expressed in newton per metre (N/m).
3.11
vapour pressure
vapour pressure of a liquid OE that defines its volatility
Note 1 to entry: Vapour pressure is expressed in Pascal (Pa) at (35 ± 2) °C.
2 © ISO 2015 – All rights reserved
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SIST EN ISO 16672:2015
ISO 16672:2015(E)
4 Intended performance
The general requirements for the intended performance of non-active surgical implants specified in
ISO 14630 shall apply.
This International Standard describes non-solid medical devices which are compatible with the ocular
environment, used to reposition and/or tamponade a detached retina, and which function primarily
mechanically. They are used either intra-operatively and removed at the end of surgery, as in the case
of heavy liquids such as perfluorocarbons, or are designed to remain in the vitreous cavity until a
reattachment of the retina is achieved.
The manufacturer shall describe and document the functional characteristics of the OE in terms of
its chemical composition and physical properties, the intended surgical applications, the conditions
of use and the maximum duration of contact with, and effects upon, ocular tissues, with particular
regard to safety.
The intended performance shall be determined, taking into account published standards, published
clinical and scientific literature, validated test results, pre-clinical and clinical evaluation, and clinical
investigations.
5 Design attributes
5.1 General
The general requirements for non-active surgical implants specified in ISO 14630 shall apply.
All testing requirements specified below shall be performed with finished, sterilized product, ready for
release. Any analytical methods utilized shall be validated.
NOTE Tests described herein are intended to apply when qualifying materials and not necessarily as a
routine quality assurance/control programme.
5.2 Chemical and biological contaminants
The identification of potentially hazardous chemical or biological contaminants shall be determined
by a risk analysis. For raw materials of biological origin, these impurities can include proteins, nucleic
acids, or other biological materials. Contaminants of the finished product derived from the source
materials or from the manufacturing process, such as cross-linking agents and antioxidants, that are
potentially hazardous to the tissues of the eye, or systemically, shall be identified and quantified,
whenever possible, and their concentration in the finished products 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 documented. Testing for the
biological effects of these contaminants during evaluation of biological safety may be required if the
risk analysis determines it necessary.
5.3 Chemical description
The manufacturer shall provide a description of each chemical component in the finished product and
its quality specifications. If the component material is derived from biological sources, the organism
from which it is obtained shall be stated along with its source. For synthetic polymers, the backbone
and end-groups shall be identified. Residual monomers and reaction by-products shall be quantified
and identified, if possible.
© ISO 2015 – All rights reserved 3
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SIST EN ISO 16672:2015
ISO 16672:2015(E)
5.4 Concentration of the components
The concentration of each component material in the finished product shall be stated. Since the testing
methodology can affect the actual concentration reported, the physical or chemical techniques utilized
shall be described and validated.
5.5 Density
3
The density of liquid forms of OE shall be specified in kilograms per cubic metre (kg/m ).
5.6 Gaseous expansion
For gaseous forms of OE the intraocular gaseous expansion at (35 ± 2) °C and its dependence on
atmospheric pressure shall be expressed.
5.7 Interfacial tension
Where applicable, the interfacial tension against water shall be expressed in newton per metre (N/m)
at (35 ± 2) °C.
5.8 Kinematic viscosity
Where applicable, the kinematic viscosity at (35 ± 2) °C shall be expressed in millimetres squared per
2
second (mm /s).
5.9 Dynamic viscosity
For viscous or viscoelastic OE, the dynamic viscosity shall be determined at (35 ± 2) °C in the range
−1
between 0,01 and 100 s and expressed in mPa⋅s.
5.10 Molecular mass distribution
If the OE is a polymer, the average molecular mass, the range of molecular mass distribution and the
polydispersity shall be reported.
The manufacturer shall conduct and report such additional tests as necessary to provide an adequate
description of the molecular mass distribution of the components in the finished product. Whenever
possible, standard methods shall be used and specified.
5.11 Particul
...
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