SIST EN ISO 16671:2015
(Main)Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015)
Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015)
This International Standard defines requirements with regards to safety for the intended performance,
design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling,
and the information supplied by the manufacturer.
This International Standard applies to ophthalmic irrigating solutions (OIS), used during ophthalmic
surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic
function.
Ophthalmische Implantate - Spüllösungen für die ophthalmische Chirurgie (ISO 16671:2015)
Mit Bezug auf die Sicherheit legt diese Internationale Norm Anforderungen für die beabsichtigte Funktion, Konstruktionsmerkmale, präklinische und klinische Auswertungen, Sterilisation, Verpackung, Kennzeichnung und die Bereitstellung von Informationen durch den Hersteller fest.
Diese Internationale Norm befasst sich mit ophthalmischen Spüllösungen, die in der Ophthalmo-Chirurgie zum Einsatz kommen. Diese Spüllösungen weisen keine primär immunologische, pharmakologische oder metabolische Funktion auf.
Implants ophtalmiques - Solutions d'irrigation pour la chirurgie ophtalmique (ISO 16671:2015)
L'ISO 16671:2015 définit des exigences en matière de sécurité dans les performances prévues, les attributs de conception, les évaluations précliniques et cliniques, la stérilisation, l'emballage des produits, l'étiquetage des produits et les informations données par le fournisseur.
L'ISO 16671:2015 s'applique aux solutions d'irrigation ophtalmique utilisées en chirurgie ophtalmique. Elles n'ont pas de fonction immunologique, pharmacologique ou métabolique primaire.
Očesni vsadki (implantati) - Raztopine za izpiranje za očesno kirurgijo (ISO 16671:2015)
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.
Ta mednarodni standard se uporablja za raztopine za izpiranje za očesno kirurgijo (OIS), ki se uporabljajo med kirurškimi posegi. Te raztopine ne zagotavljajo nobene primarne imunološke, farmakološke ali metabolične funkcije.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 16671:2015
01-oktober-2015
1DGRPHãþD
SIST EN ISO 16671:2004
2þHVQLYVDGNL LPSODQWDWL 5D]WRSLQH]DL]SLUDQMH]DRþHVQRNLUXUJLMR ,62
Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2015)
Ophthalmische Implantate - Spüllösungen für die ophthalmische Chirurgie (ISO
16671:2015)
Implants ophtalmiques - Solutions d'irrigation pour la chirurgie ophtalmique (ISO
16671:2015)
Ta slovenski standard je istoveten z: EN ISO 16671:2015
ICS:
11.040.70 Oftalmološka oprema Ophthalmic equipment
SIST EN ISO 16671:2015 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 16671:2015
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SIST EN ISO 16671:2015
EUROPEAN STANDARD
EN ISO 16671
NORME EUROPÉENNE
EUROPÄISCHE NORM
August 2015
ICS 11.040.70 Supersedes EN ISO 16671:2003
English Version
Ophthalmic implants - Irrigating solutions for ophthalmic surgery
(ISO 16671:2015)
Implants ophtalmiques - Solutions d'irrigation pour la Ophthalmische Implantate - Spüllösungen für die
chirurgie ophtalmique (ISO 16671:2015) ophthalmische Chirurgie (ISO 16671:2015)
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 16671:2015 E
worldwide for CEN national Members.
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SIST EN ISO 16671:2015
EN ISO 16671:2015 (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 16671:2015
EN ISO 16671:2015 (E)
European foreword
This document (EN ISO 16671:2015) 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 16671:2003.
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 16671:2015
EN ISO 16671:2015 (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 16671:2015 has been approved by CEN as EN ISO 16671:2015 without any modification.
4
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SIST EN ISO 16671:2015
EN ISO 16671:2015 (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
5.4.3 & 5.4.6, 7.2
7 in respect of EO contamination
only.
6.3 7.3
7 7.6
7 8.1
5.2, 5.4.3, 6.2.1 8.2
9, 8.3
10 in respect of exposure to
environmental elements
7 in respect of EO sterilization 8.4
10 13.1
10 13.2
10 13.3 a), b), c), d),
e), f), i), j), k), m)
5
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SIST EN ISO 16671:2015
EN ISO 16671:2015 (E)
10 13.4
10 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 16671:2015
INTERNATIONAL ISO
STANDARD 16671
Second edition
2015-08-01
Ophthalmic implants — Irrigating
solutions for ophthalmic surgery
Implants ophtalmiques — Solutions d’irrigation pour la chirurgie
ophtalmique
Reference number
ISO 16671:2015(E)
©
ISO 2015
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SIST EN ISO 16671:2015
ISO 16671:2015(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 16671:2015
ISO 16671:2015(E)
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Intended performance . 2
5 Design attributes . 2
5.1 General . 2
5.2 Concentration of the components . 2
5.3 Water used . 3
5.4 Characterization of the finished product . 3
5.4.1 General. 3
5.4.2 pH and buffering capacity . 3
5.4.3 Chemical and biological contaminants . 3
5.4.4 Osmolality . 4
5.4.5 Spectral transmittance . . 4
5.4.6 Particulates . 4
6 Design evaluation . 5
6.1 General . 5
6.2 Preclinical evaluation of biological safety . 5
6.2.1 General. 5
6.2.2 Bacterial endotoxins test . 5
6.2.3 Intraocular irritation and inflammation . 5
6.3 Clinical evaluation . 6
7 Sterilization . 6
8 Product stability . 6
9 Packaging . 7
9.1 Protection from damage during storage and transport. 7
9.2 Maintenance of sterility in transit . 7
10 Information supplied by the manufacturer . 7
Annex A (informative) Example of a suitable method for pH measurement and buffer
capacity determination . 9
Annex B (normative) Particulate contamination: Visible particulates .10
Annex C (informative) Light obscuration test method for particulate contamination: sub-
visible particles .11
Annex D (informative) Microscopic test method for particulate contamination: sub-
visible particles .13
Annex E (normative) Intraocular irrigation test .18
Annex F (informative) Clinical investigation .19
Bibliography .22
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SIST EN ISO 16671:2015
ISO 16671:2015(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 16671:2003), which has been
technically revised.
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SIST EN ISO 16671:2015
INTERNATIONAL STANDARD ISO 16671:2015(E)
Ophthalmic implants — Irrigating solutions for
ophthalmic surgery
1 Scope
This International Standard defines requirements with regards to safety for the intended performance,
design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling,
and the information supplied by the manufacturer.
This International Standard applies to ophthalmic irrigating solutions (OIS), used during ophthalmic
surgery. These solutions do not provide any primary immunological, pharmacological, or metabolic
function.
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 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 22442-1:2007, Medical devices utilizing animal tissues and their derivatives — Part 1: Application of
risk management
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.
3.1
delivery system
sealed container in which the product is supplied and any additional components provided to introduce
the product into the eye
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SIST EN ISO 16671:2015
ISO 16671:2015(E)
3.2
ophthalmic irrigating solution
OIS
aqueous solution that is physiologically compatible with the intraocular environment and functions
solely by mechanical means
Note 1 to entry: It does not provide any primary immunological, pharmacological, or metabolic function.
3.3
primary container
container providing mechanical and microbiological protection of the content
3.4
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]
3.5
storage container
part of the packaging intended to protect the device during transport and storage, containing the
sterile barrier
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 rinse the ocular surface or intraocular spaces and structures.
The manufacturer shall describe and document the functional characteristics of the OIS in terms of its
chemical composition and physical properties, the intended surgical applications, the conditions of use
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 outlined 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 Concentration of the components
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
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SIST EN ISO 16671:2015
ISO 16671:2015(E)
potentially hazardous to the tissues of the eye, or systemically, shall be identified, whenever possible,
and their concentration in the finished products 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 documented. Testing for the
biological effects of these contaminants during evaluation of biological safety may be required if the
risk analysis determines it necessary.
The concentration of each component material in the finished product shall be determined and
documented, and the concentration of each component shall be expressed as weight of material per
unit volume of solution. Since the testing methodology can affect the actual concentration reported,
the standard physical or chemical techniques utilized shall be described and documented. Wherever
possible, components shall comply with stated compendial standards.
5.3 Water used
The purity of the water used shall be Water for Injections (see Reference [3]).
5.4 Characterization of the finished product
5.4.1 General
The manufacturer shall describe and document the physical characteristics that affect the performance
of the OIS efficacy in ophthalmic surgery.
These physical properties should be measured at the conditions expected and relevant at the time of use.
5.4.2 pH and buffering capacity
The pH of the finished product shall be determined and documented with a calibrated pH meter at
25 °C ± 2 °C.
The pH of the product should be close to that of the aqueous humour (pH 7,38) in order to prevent
damage to the corneal endothelial cells. In vitro studies have shown that the pH range tolerated by the
endothelium narrows as exposure time increases.
A suitable method shall be used to determine buffering capacity. An example of a suitable method is
given in Annex A. The products shall be classified as in Table 1.
Table 1 — Classification according to pH and buffering capacity
Base buffering capacity Acid buffering capacity
Group pH range
(mol/l per pH) (mol/l per pH)
Essentially unbuffered <0,000 5 <0,004 6,5 to 8,5
Moderately buffered 0,000 5 to 0,005 0,004 to 0,04 6,7 to 8,2
Buffered >0,005 >0,04 7,2 to 7,6
5.4.3 Chemical and biological contaminants
Potentially hazardous chemical or biological contaminants and impurities shall be determined by a risk
analysis. For raw materials of biological origin, these contaminants can include proteins, nucleic acids or
other biological materials. Contaminants of the finished product that are potentially hazardous either
to the tissues of the eye or systemically, shall be identified, whenever possible, and their concentrations
in the finished product 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 16671:2015
ISO 16671:2015(E)
effects of these contaminants during evaluation of biological safety may be required if the risk analysis
determines it necessary.
5.4.4 Osmolality
The manufacturer shall determine and document the osmolality range of the OIS. Osmolality of the
finished product shall be not less than 200 mosm/kg or greater than 400 mosm/kg. Osmolality shall be
determined using either a vapour pressure osmometer or a cryoscopic osmometer.
5.4.5 Spectral transmittance
The spectral transmittance of the finished product shall be recorded over the range 300 nm to 1 100 nm.
Results shall be presented graphically, plotting % transmission against wavelength.
5.4.6 Particulates
5.4.6.1 General
There is a potential for adverse events to take place as a result of particles of certain sizes and
characteristics in the finished product.
Particulate contamination of OIS consists of extraneous, mobile undissolved particles other than gas
bubbles, unintentionally present in the solutions.
A risk assessment shall evaluate the potential for contamination by, or formation of, particulates in
the product during manufacture as well as the conditions expected during transport and storage, and
during use of the product and the hazards associated with these.
In multi-component products (i.e. where there are two or more separate parts of a product that have to
be mixed prior to use) tests shall be applied to the mixed product.
5.4.6.2 Visible particles
The OIS shall be essentially free of visible particles. The method described in Annex B shall be used to
determine this.
5.4.6.3 Sub-visible particles
Ei
...
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