SIST EN ISO 16672:2003
(Main)Ophthalmic implants - Ocular endotamponades (ISO 16672:2003)
Ophthalmic implants - Ocular endotamponades (ISO 16672:2003)
Specification of fundamental requirements for endotamponades used in ocular surgery.
Ophthalmische Implantate - Okulare Endotamponaden (ISO 16672:2003)
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 16672:2003)
L'ISO 16672:2002 s'applique aux produits de tamponnements 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 tamponnements endoculaires, l'ISO 16672:2002 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 16672:2003)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 16672:2003
01-september-2003
2þHVQLYVDGNL LPSODQWDWL ±6UHGVWYD]DQRWUDQMRRþHVQRWDPSRQDGR ,62
Ophthalmic implants - Ocular endotamponades (ISO 16672:2003)
Ophthalmische Implantate - Okulare Endotamponaden (ISO 16672:2003)
Implants ophtalmiques - Produits de tamponnement endoculaires (ISO 16672:2003)
Ta slovenski standard je istoveten z: EN ISO 16672:2003
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 16672:2003 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 16672:2003
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SIST EN ISO 16672:2003
EUROPEAN STANDARD
EN ISO 16672
NORME EUROPÉENNE
EUROPÄISCHE NORM
February 2003
ICS 11.040.70
English version
Ophthalmic implants - Ocular endotamponades (ISO
16672:2003)
Implants ophtalmiques - Produits de tamponnement Ophthalmische Implantate - Okulare Endotamponaden
endoculaires (ISO 16672:2003) (ISO 16672:2003)
This European Standard was approved by CEN on 2 January 2003.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European
Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national
standards may be obtained on application to the Management Centre or to any CEN member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CEN member into its own language and notified to the Management Centre has the same status as the official
versions.
CEN members are the national standards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Luxembourg, Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and United
Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: rue de Stassart, 36 B-1050 Brussels
© 2003 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 16672:2003 E
worldwide for CEN national Members.
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SIST EN ISO 16672:2003
EN ISO 16672:2003 (E)
CORRECTED 2003-03-19
Foreword
This document (EN ISO 16672:2003) has been prepared by Technical Committee ISO/TC 172 "Optics
and optical instruments" in collaboration with Technical Committee CEN/TC 170 "Ophthalmic optics",
the secretariat of which is held by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by August 2003, and conflicting national standards shall
be withdrawn at the latest by August 2003.
According to the CEN/CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Czech
Republic, Denmark, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Luxembourg,
Malta, Netherlands, Norway, Portugal, Slovakia, Spain, Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 16672:2003 has been approved by CEN as EN ISO 16672:2003 without any
modifications.
NOTE Normative references to International Standards are listed in Annex ZA (normative).
2
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SIST EN ISO 16672:2003
EN ISO 16672:2003 (E)
Annex ZA
(normative)
Normative references to international publications
with their relevant European publications
This European Standard incorporates by dated or undated reference, provisions from other publications.
These normative references are cited at the appropriate places in the text and the publications are listed
hereafter. For dated references, subsequent amendments to or revisions of any of these publications
apply to this European Standard only when incorporated in it by amendment or revision. For undated
references the latest edition of the publication referred to applies (including amendments).
NOTE Where an International Publication has been modified by common modifications, indicated by
(mod.), the relevant EN/HD applies.
Publication Year Title EN Year
ISO 10993-1 1997 Biological evaluation of medical devices - EN ISO 10993-1 1997
Part 1: Evaluation and testing
ISO 10993-2 1992 Biological evaluation of medical devices - EN ISO 10993-2 1998
Part 2: Animal welfare requirements
ISO 10993-6 1994 Biological evaluation of medical devices - EN 30993-6 1994
Part 6: Tests for local effects after
implantation
ISO 14630 1997 Non-active surgical implants - General EN ISO 14630 1997
requirements
ISO 14971 2000 Medical devices - Application of risk EN ISO 14971 2000
management to medical devices
3
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SIST EN ISO 16672:2003
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SIST EN ISO 16672:2003
INTERNATIONAL ISO
STANDARD 16672
First edition
2003-02-01
Ophthalmic implants — Ocular
endotamponades
Implants ophtalmiques — Produits de tamponnement endoculaires
Reference number
ISO 16672:2003(E)
©
ISO 2003
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SIST EN ISO 16672:2003
ISO 16672:2003(E)
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ii © ISO 2003 — All rights reserved
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SIST EN ISO 16672:2003
ISO 16672:2003(E)
Contents Page
Foreword. iv
1 Scope. 1
2 Normative references . 1
3 Terms and definitions. 2
4 Intended performance . 2
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 . 3
5.5 Density . 3
5.6 Gaseous expansion . 3
5.7 Interfacial tension . 3
5.8 Kinematic viscosity. 4
5.9 Molecular mass distribution . 4
5.10 Particulates. 4
5.11 Refractive index . 4
5.12 Spectral transmittance . 4
5.13 Surface tension . 4
5.14 Vapour pressure. 4
6 Design evaluation . 4
6.1 General. 4
6.2 Evaluation of biological safety . 5
6.3 Clinical investigation . 6
7 Sterilization. 6
8 Product stability. 6
9 Integrity and performance of the delivery system. 6
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 2003 — All rights reserved iii
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SIST EN ISO 16672:2003
ISO 16672:2003(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 16672 was prepared by Technical Committee ISO/TC 172, Optics and optical instruments, Subcommittee
SC 7, Ophthalmic optics and instruments.
iv © ISO 2003 — All rights reserved
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SIST EN ISO 16672:2003
INTERNATIONAL STANDARD ISO 16672:2003(E)
Ophthalmic implants — Ocular endotamponades
1 Scope
This International Standard applies to ocular endotamponades (OEs), 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 OEs, 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 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 10993-1:1997, Biological evaluation of medical devices — Part 1: Evaluation and testing
ISO 10993-2:1992, Biological evaluation of medical devices — Part 2: Animal welfare requirements
ISO 10993-6:1994, Biological evaluation of medical devices — Part 6: Tests for local effects after implantation
ISO 11607:1997, Packaging for terminally sterilized medical devices
ISO 13408-1:1998, Aseptic processing of health care products — Part 1: General requirements
1)
ISO 14155-1:— , Clinical investigation of medical devices for human subjects — Part 1: General
requirements
1)
ISO 14155-2:— , Clinical investigation of medical devices for human subjects — Part 2: Clinical investigation
plans
ISO 14630:1997, Non-active surgical implants — General requirements
ISO 14971:2000, Medical devices — Application of risk management to medical devices
ISO/TR 15223:2000, Medical devices — Symbols to be used with medical device labels, labelling and
information to be supplied
EN 868-1:1997, Packaging materials and systems for medical devices which are to be sterilized — Part 1:
General requirements and test methods
EN 1041:1998, Information supplied by the manufacturer with medical devices
USP 24 <85> Jan/2000, United States Pharmacopoeia <85> Bacterial endotoxins test
1) To be published.
© ISO 2003 — All rights reserved 1
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SIST EN ISO 16672:2003
ISO 16672:2003(E)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
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 The dynamic viscosity is expressed in pascal seconds (Pa⋅s).
3.3
interfacial tension
tension against liquids
NOTE The interfacial tension is expressed in newtons per metre (N/m).
3.4
kinematic viscosity
quotient of the dynamic viscosity with the gravity
2
NOTE The kinematic viscosity is expressed in metres squared per second (m /s).
3.5
non-solid implants
tamponade media such as gases, liquids or gels
3.6
surface tension
tension against air
NOTE Surface tension is expressed in newtons per metre (N/m).
3.7
vapour pressure
vapour pressure of a liquid OE that defines its volatility
NOTE Vapour pressure is expressed in conventional millimetres of mercury (mmHg) at (35 ± 2) °C.
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.
2 © ISO 2003 — All rights reserved
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SIST EN ISO 16672:2003
ISO 16672:2003(E)
The intended performance shall be determined, taking into account published standards, published clinical
and scientific literature, 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 may 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, 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.
5.4 Concentration of the components
The concentration of each component material in the finished product shall be stated. Since the testing
methodology may affect the actual concentration reported, the physical or chemical techniques utilized shall
be described.
5.5 Density
The density of liquid forms of OEs shall be specified in kilograms per cubic metre (kg/m³).
5.6 Gaseous expansion
For gaseous forms of OEs 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 shall be expressed in newtons per metre (N/m) at (35 ± 2) °C.
© ISO 2003 — All rights reserved 3
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SIST EN ISO 16672:2003
ISO 16672:2003(E)
5.8 Kinematic viscosity
2
Where appli
...
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