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)
ISO 16671:2015 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.
ISO 16671:2015 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 (OIS, en: ophthalmic irrigating solution), 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
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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.
Contents Page
European foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC .5
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 —
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.
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)
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.
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
ISO 16671:2015(E)
© ISO 2015, Published in Switzerland
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ii © ISO 2015 – All rights reserved
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 .
...
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