EN ISO 16671:2003
(Main)Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2003)
Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2003)
ISO 16671:2002 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 16671:2002 applies to ophthalmic irrigating solutions (OISs), used during ophthalmic surgery. These solutions do not provide any primary immunological, pharmacological or metabolic function.
Ophthalmische Implantate - Spüllösungen für die ophthalmische Chirurgie (ISO 16671:2003)
Implants ophtalmiques - Solutions d'irrigation pour la chirurgie ophtalmique (ISO 16671:2003)
L'ISO 16671:2002 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 16671:2002 s'applique aux solutions d'irrigation ophtalmique utilisées en chirurgie ophtalmique. Elles n'ont pas de fonction immunologique, pharmacologique ou métabolique primaire.
Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2003)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-februar-2004
Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2003)
Ophthalmic implants - Irrigating solutions for ophthalmic surgery (ISO 16671:2003)
Ophthalmische Implantate - Spüllösungen für die ophthalmische Chirurgie (ISO
16671:2003)
Implants ophtalmiques - Solutions d'irrigation pour la chirurgie ophtalmique (ISO
16671:2003)
Ta slovenski standard je istoveten z: EN ISO 16671:2003
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
November 2003
ICS 11.040.70
English version
Ophthalmic implants - Irrigating solutions for ophthalmic surgery
(ISO 16671:2003)
Implants ophtalmiques - Solutions d'irrigation pour la Ophthalmische Implantate - Spüllösungen für die
chirurgie ophtalmique (ISO 16671:2003) ophthalmische Chirurgie (ISO 16671:2003)
This European Standard was approved by CEN on 3 November 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 16671:2003 E
worldwide for CEN national Members.
Foreword
The text of ISO 16671:2003 has been prepared by Technical Committee ISO/TC 172 "Optics
and optical instruments" of the International Organization for Standardization (ISO) and has
been taken over as EN ISO 16671:2003 by 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 May 2004, and conflicting national
standards shall be withdrawn at the latest by May 2004.
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 16671:2003 has been approved by CEN as EN ISO 16671:2003 without any
modifications.
NOTE Normative references to International Standards are listed in Annex ZA (normative).
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 10993-2 1992 Biological evaluation of medical EN ISO 10993-2 1998
devices - Part 2: Animal welfare
requirements
ISO 14155-1 2003 Clinical investigation of medical EN ISO 14155-1 2003
devices for human subjects - Part
1: General requirements
ISO 14155-2 2003 Clinical investigation of medical EN ISO 14155-2 2003
devices for human subjects - Part
2: Clinical investigation plans
ISO 14630 1997 Non-active surgical implants - EN ISO 14630 1997
General requirements
INTERNATIONAL ISO
STANDARD 16671
First edition
2003-05-01
Ophthalmic implants — Irrigating
solutions for ophthalmic surgery
Implants ophtalmiques — Solutions d'irrigation pour la chirurgie
ophtalmique
Reference number
ISO 16671:2003(E)
©
ISO 2003
ISO 16671:2003(E)
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ii © ISO 2003 — All rights reserved
ISO 16671:2003(E)
Contents Page
Foreword. iv
1 Scope. 1
2 Normative references. 1
3 Terms and definitions. 2
4 Intended performance. 2
5 Design attributes. 2
6 Design evaluation. 4
7 Sterilization. 5
8 Product stability. 6
9 Packaging. 6
10 Information supplied by the manufacturer. 6
Annex A (informative) Example of a suitable method for pH measurement and buffer capacity
determination . 8
Annex B (normative) Particulate contamination: visible particulates . 9
Annex C (informative) Light obscuration test method for particulate contamination: subvisible
particles. 10
Annex D (informative) Microscopic test method for particulate contamination: subvisible particles . 12
Annex E (normative) Intraocular irrigation test. 17
Annex F (informative) Clinical investigation. 18
Bibliography . 21
ISO 16671:2003(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 16671 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
INTERNATIONAL STANDARD ISO 16671:2003(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 (OISs), used during ophthalmic surgery.
These solutions do not provide any primary immunological, pharmacological or metabolic function.
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.
1)
ISO 10993-1:— , 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 11607:2002, Packaging for terminally sterilized medical devices
ISO 13408-1:1998, Aseptic processing of health care products — Part 1: General requirements
ISO 14155-1, Clinical investigation of medical devices for human subjects — Part 1: General requirements
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 14971-1:1998, Medical devices — Risk management — Part 1: Application of risk analysis
ISO 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
EN 12442-1:2000, Animal tissues and their derivatives utilized in the manufacture of medical devices —
Part 1: Analysis and management of risk
1) To be published. (Revision of ISO 10993-1:1997)
ISO 16671:2003(E)
3 Terms and definitions
For the purposes of this International Standard, 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
3.2
ophthalmic irrigating solution (OIS)
aqueous solution that is physiologically compatible with the intraocular environment and functions solely by
mechanical means
NOTE It does not provide any primary immunological, pharmacological or metabolic function.
4 Intended performance
The intended performance of the product shall be defined by the manufacturer. The intended performance
shall include the general requirements for the intended performance of non-active surgical implants outlined in
ISO 14630.
The extent to which the intended performance has been achieved shall be determined, taking into account
publ
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