1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 9394:2012Ophthalmic optics Contactlenses and contact lens careproducts Determinationof biocompatibility by ocularstudy with rabbit eyesBS EN ISO 9394:2012 BRITISH STAND
2、ARDNational forewordThis British Standard is the UK implementation of EN ISO 9394:2012. It supersedes BS EN ISO 9394:1998, which is withdrawn.The UK participation in its preparation was entrusted to T e c h n i c a l C o m m i t t e e C H / 1 7 2 / 9 , C o n t a c t l e n s e s a n d c o n t a c t l
3、 e n s care products.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The British Standards Institution 2012. P
4、ublished by BSI Standards Limited 2012.ISBN 978 0 580 74794 6 ICS 11.040.70 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 31 October 2012.Amendments issued sin
5、ce publicationDate T e x t a f f e c t e dEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 9394 October 2012 ICS 11.040.70 Supersedes EN ISO 9394:1998English Version Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rab
6、bit eyes (ISO 9394:2012) Optique ophtalmique - Lentilles de contact et produits dentretien pour lentilles de contact - Dtermination de la biocompatibilit par valuation de la tolrance oculaire chezle lapin (ISO 9394:2012) Augenoptik - Kontaktlinsen und Kontaktlinsenpflegemittel - Bestimmung der Bioko
7、mpatibilitt durch Erprobung am Kaninchenauge (ISO 9394:2012) This European Standard was approved by CEN on 30 September 2012. 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 w
8、ithout 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 oth
9、er 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,
10、 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 COMM
11、ITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 9394:2012: EBS EN ISO 9394:2012EN
12、 ISO 9394:2012 (E) 3 Foreword This document (EN ISO 9394:2012) 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
13、of a national standard, either by publication of an identical text or by endorsement, at the latest by April 2013, and conflicting national standards shall be withdrawn at the latest by April 2013. Attention is drawn to the possibility that some of the elements of this document may be the subject of
14、 patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 9394:1998. According to the CEN/CENELEC Internal Regulations, the national standards organisations of the following countries are bound to implement this Eu
15、ropean 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, S
16、lovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom. Endorsement notice The text of ISO 9394:2012 has been approved by CEN as a EN ISO 9394:2012 without any modification. BS EN ISO 9394:2012ISO 9394:2012(E) ISO 2012 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope
17、12 Normative references . 13 Terms and definitions . 14 General requirements . 15 Animals and husbandry . 16 Reagents/materials . 27 Apparatus 28 Test specimens 38.1 Lens parameters 38.2 Preparation and storage 39 Test procedure . 39.1 Preliminary examination of animals . 39.2 Insertion and removal
18、of test lens 49.3 Examination of the rabbits eye . 49.4 Weighing of animals . 49.5 Histological examination . 59.6 Corneal metabolism 510 Assessment of results . 511 Test report . 5Annex A (normative) McDonald-Shadduck score system Slit lamp 7Annex B (normative) Draize scale for scoring ocular lesio
19、ns 11Bibliography .13BS EN ISO 9394:2012ISO 9394:2012(E)ForewordISO (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.
20、 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 Interna
21、tional 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 Standa
22、rds 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
23、of patent rights. ISO shall not be held responsible for identifying any or all such patent rights.ISO 9394 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments.This third edition cancels and replaces the second edition (ISO 9394:1
24、998), which has been technically revised.iv ISO 2012 All rights reservedBS EN ISO 9394:2012ISO 9394:2012(E)IntroductionThe ocular tissue of the rabbit is traditionally used to evaluate the irritant properties of materials which come in contact with ocular tissue.The use of the device under evaluatio
25、n is governed by the nature, degree, duration, frequency and conditions of exposure of humans to the device in normal intended use.It is incumbent upon the investigator to conduct such evaluations using good scientific laboratory practices, complying with regulations related to animal welfare and th
26、e general principles set forth in the normative references.ISO 10993-1 is the basic horizontal International Standard for biological evaluation of medical devices, and serves as a framework for planning biological evaluation tests.ISO 10993-10 assesses possible contact hazards from device-released c
27、hemicals that may produce skin and mucosal irritation, eye irritation and delayed contact sensitization.Usage tests for specific devices are defined in vertical standards. This International Standard describes one of several specific usage tests for contact lenses and contact lens care products.The
28、existence of this International Standard does not imply that rabbit-eye testing is a requirement in the determination of biocompatibility of contact lenses and contact lens care products, nor that this test is sufficient by itself to determine the biocompatibility of contact lenses and contact lens
29、care products. Taking into consideration animal welfare requirements (ISO 10993-2), it is recommended that this in vivo test be carried out after obtaining data of in vitro toxicological testing such as that described in ISO 10993-5.Care should be taken when extrapolating the test results to the hum
30、an eye. ISO 2012 All rights reserved vBS EN ISO 9394:2012BS EN ISO 9394:2012Ophthalmic optics Contact lenses and contact lens care products Determination of biocompatibility by ocular study with rabbit eyes1 ScopeThis International Standard specifies an in vivo method of test to assess the ocular sa
31、fety of both novel contact lens material and contact lens care products. The test assesses the degree of irritation to the ocular tissue produced by the device under test. The test method is described in application to rabbit eyes.2 Normative referencesThe following referenced documents are indispen
32、sable 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, Biological evaluation of medical devices Part 1: Evaluation and testing within a ris
33、k management processISO 10993-2, Biological evaluation of medical devices Part 2: Animal welfare requirementsISO 10993-10, Biological evaluation of medical devices Part 10: Tests for irritation and skin sensitizationISO 18369-1, Ophthalmic optics Contact lenses Part 1: Vocabulary, classification sys
34、tem and recommendations for labelling specificationsISO/IEC 17025, General requirements for the competence of testing and calibration laboratoriesOECD 1997, OECD Principles of Good Laboratory Practice, No.13 Terms and definitionsFor the purposes of this document, the terms and definitions given in I
35、SO 18369-1 apply.4 General requirementsThe general principles for biological evaluation and categorization of medical devices given in ISO 10993-1 shall apply. The study shall be performed in accordance with ISO/IEC 17025 and Good Laboratory Practice (GLP) (OECD, Principles of Good Laboratory Practi
36、ce, No.1).Tests for irritation and sensitization of contact lenses and contact lens care products shall be carried out in accordance with ISO 10993-10.The assessment of the results shall be carried out by appropriately experienced and competent personnel.5 Animals and husbandry5.1 New Zealand white
37、strain rabbits (male, female or mixed sexes) or equivalent albino rabbits shall be used to test each type of contact lens or lens care product. They shall be healthy young adults from a single strain INTERNATIONAL STANDARD ISO 9394:2012(E) ISO 2012 All rights reserved 1BS EN ISO 9394:2012ISO 9394:20
38、12(E)from a single recognized source weighing 2,5 kg. They shall have eyes free from clinically significant ocular irritation or corneal retention of fluorescein stain.A minimum number of three rabbits shall be used, however a number of six is recommended to ensure an acceptable level of precision o
39、f the test results. If less than six rabbits are used, then the quantity shall be justified.If control articles are included in the evaluation, use the contra-lateral eye or an additional group of animals with the same number of animals chosen as before for each control article. For contact lens car
40、e products, the control group should use the same type of contact lens which has not been treated with the test product.Positive controls shall not be used.NOTE In this context, “control article“ should be interpreted as being a device with defined safety and performance characteristics.5.2 The anim
41、al welfare requirements set out in ISO 10993-2 shall be met.5.3 The animals shall be housed individually and have free access to commercially pelted rabbit feed and tap water. Group housing is not feasible in this test since any lens found expulsed from the eye shall be matched to the specific rabbi
42、t which wore the lens and re-inserted into the same eye.5.4 Each animal shall be identified by one of the following:a) a numbered ear tag;b) a tattoo;c) a microchip; ord) a permanent ink marking.The animals shall be acclimatized to the laboratory conditions for at least five days prior to testing.5.
43、5 The nictitating membrane should not be removed from the rabbits eyes, and the eyelids should not be sutured during lens wear. Any deviations shall be justified and documented in the test report.NOTE The albino rabbit eye is free of pigment, easily examined and has historically been used for ocular
44、 irritation studies.All appropriate regulatory requirements governing the care and use of animals shall be followed.5.6 During daily treatment, the rabbits shall be minimally restrained.6 Reagents/materials6.1 Sodium fluorescein, as specified by an appropriate pharmacopoeia.NOTE Attention should be
45、made to the degree of staining and the concentration of fluorescein administered to the eye (e.g. 3 l of 1 % fluorescein in saline solution).6.2 Contact lens care products, as recommended by the manufacturers.6.3 Contact lenses, as recommended by the manufacturer.7 Apparatus7.1 Slit lamp microscope,
46、 with appropriate filters.2 ISO 2012 All rights reservedBS EN ISO 9394:2012ISO 9394:2012(E)7.2 Magnifying glass, of minimum magnification 6.7.3 Balance or weighing machine, capable of weighing up to 5 kg to an accuracy of 100 g.8 Test specimens8.1 Lens parametersContact lenses shall be sufficiently
47、thick to represent eithera) reasonable human use extremes; orb) the extreme of the manufacturers product line.The contact lens selected shall produce a good fit to a rabbit eye.NOTE This is necessary to minimize physical irritation and expulsion. In the case where this thickness does not allow a goo
48、d fit of the contact lens, a contact lens of the greatest thickness which allows a good fit should be used.Contact lens parameters shall be documented in the final report.8.2 Preparation and storageIf contact lens care products are to be used in the evaluation, lenses shall be prepared, cleaned, dis
49、infected, stored and rinsed according to the lens manufacturers instructions using contact lens care products (6.2). If a lens falls out during the daily treatment period, it shall be rinsed with rinsing solution (6.2) and re-inserted into the rabbits eye from which it has fallen out.NOTE 1 Sufficient additional lenses should be treated using at least one complete daily lens care treatment to replace any lenses that are damaged or lost during the lens-wear day.NOTE 2 Hydrogel lenses which cannot be immediately reinserted because of
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