DIN EN ISO 14729-2011 Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact le.pdf

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1、January 2011 Translation by DIN-Sprachendienst.English price group 14No part of this translation may be reproduced without prior permission ofDIN Deutsches Institut fr Normung e. V., Berlin. Beuth Verlag GmbH, 10772 Berlin, Germany,has the exclusive right of sale for German Standards (DIN-Normen).IC

2、S 11.040.70; 11.080.20!$m2;“1741524www.din.deDDIN EN ISO 14729Ophthalmic optics Contact lens care products Microbiological requirements and test methods for products andregimens for hygienic management of contact lenses (ISO 14729:2001 +Amd. 1:2010)English translation of DIN EN ISO 14729:2011-01Auge

3、noptik Kontaktlinsenpflegemittel Mikrobiologische Anforderungen und Prfverfahren fr Produkte und Systeme zumHygienemanagement von Kontaktlinsen (ISO 14729:2001 + Amd. 1:2010)Englische bersetzung von DIN EN ISO 14729:2011-01Optique ophtalmique Produits dentretien des lentilles de contact Exigences mi

4、crobiologiques et mthodes dessai des produits et protocoles dentretiendes lentilles de contact (ISO 14729:2001 + Amd. 1:2010)Traduction anglaise de DIN EN ISO 14729:2011-01SupersedesDIN EN ISO 14729:2001-09www.beuth.deDocument comprises 29 pagesIn case of doubt, the German-language original shall be

5、 considered authoritative.04.11 DIN EN ISO 14729:2011-01 2 A comma is used as the decimal marker. National foreword This standard has been prepared by Technical Committee ISO/TC 172/SC 7 “Ophthalmic optics and instruments” in collaboration with Technical Committee CEN/TC 170 “Opht almic optics” (bot

6、h secretariats are held by DIN, Germany). The responsible German body involved in its preparation was the Normenausschuss Feinmechanik und Optik (Optics and Precision Mechanics Standards Committee). This standard specifies two test methods for evaluating the antimicrobial activity of products to be

7、marketed for contact lens disinfection by chemical means. The stand-alone test is designed to qualify individual solutions with a suitable level of antimicrobial activity as contact lens disinfection products. The regimen test is designed to qualify individual solutions as part of a contact lens dis

8、infecting regimen. This standard is the consolidated version of ISO 14729:2001 incorporating the Amendment ISO 14729:2001/Amd. 1:2010. The start and finish of text introduced or altered by amendment is indicated in the text by tags !“. The DIN Standard corresponding to the International Standard ref

9、erred to in this document is as follows: ISO 18369-1 DIN EN ISO 18369-1 Amendments This standard differs from DIN EN ISO 14729:2001-09 as follows: a) Subclauses 5.1.2 “Moulds and yeasts” and 5.2 “Stand alone test: Secondary criteria” have been revised; b) Subclause 5.4 “Test requirements for contact

10、 lens care products without rubbing (or mechanical cleaning) and/or rinsing steps” has been added; c) Subclause 6.4.1 “Lens inoculation” has been revised with regard to silicone hydrogel lenses; d) ISO 14729:2001 Amendment A1:2010 (EN ISO 14729:2001/Amd. 1:2010) has been incorporated. Previous editi

11、ons DIN EN ISO 14729: 2001-09 hDIN EN ISO 14729:2011-01 3 National Annex NA (informative) Bibliography DIN EN ISO 14534, Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements DIN EN ISO 14730, Ophthalmic optics Contact lens care products Antimicrobial preservative

12、efficacy testing and guidance on determining discard date DIN EN ISO 18369-1, Ophthalmic optics Contact lenses Part 1: Vocabulary, classification system and recommendations for labelling specifications ISO/TS 19979, Ophthalmic optics Contact lenses Hygienic management of multipatient use trial conta

13、ct lenses DIN EN ISO 14729:2011-01 4 This page is intentionally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 14729 April 2001 + A1 October 2010 ICS 11.040.70 English version Ophthalmic optics Contact lens care products Microbiological requirements and test methods for products and

14、regimens for hygienic management of contact lenses (ISO 14729:2001 + Amd. 1:2010) Optique ophtalmique Produits d entretien des lentilles de contact Exigences microbiologiques et mthodes d essai des produits et protocoles d entretien des lentilles de contact (ISO 14729:2001 + Amd. 1:2010) Augenoptik

15、Kontaktlinsenpflegemittel Mikrobiologische Anforderungen und Prfverfahren fr Produkte und Systeme zum Hygienemanagement von Kontaktlinsen (ISO 14729:2001 + Amd. 1:2010) EN ISO 14729 was approved by CEN on 2001-04-15 and Amendment A1:2010 on 2010-09-30. CEN members are bound to comply with the CEN/CE

16、NELEC 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 C

17、EN member. The European Standards exist 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 mem

18、bers are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden,

19、 Switzerland, and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATIONEUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref

20、. No. EN ISO 14729:2001 + A1:2010 E DIN EN ISO 14729:2011-01 EN ISO 14729:2001 + A1:2010 (E) 2 Contents Page Foreword to ISO 14729:20013 !Foreword to EN ISO 14729:2001/A1:2010 .3 Introduction .4 1 Scope 5 2 Normative references 5 3 Terms and definitions .5 4 Principle6 4.1 General6 4.2 Stand-alone t

21、est (Inoculum challenge test) 6 4.3 Regimen test 7 5 Performance requirements .7 5.1 Stand-alone test: Primary criteria (see also Table 1) 7 5.2 Stand-alone test: Secondary criteria (see also Table 1) .8 5.3 Regimen test: Regimen criteria (see also Table 1)8 !5.4 Test requirements for contact lens c

22、are products without rubbing (or mechanical cleaning) and/or rinsing steps.8 6 Test methods9 6.1 Materials and reagents9 6.2 Preparation of microbial challenge (Inoculum) 10 6.3 Stand-alone procedure11 6.4 Regimen procedure .14 Annex A (informative) Test organisms from other culture collections .17

23、Annex B (informative) Example of a membrane filtration procedure 18 Annex C (informative) Technical report: Virus testing20 Annex D (informative) Technical report: Acanthamoeba testing .21 Annex E (informative) Technical report: Artificial tears (organic soil) in laboratory testing 22 Bibliography 2

24、3 DIN EN ISO 14729:2011-01 EN ISO 14729:2001 + A1:2010 (E) 3Foreword to ISO 14729:2001 International Standard ISO 14729:2001, Ophthalmic optics Contact lens care products Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses, which was prep

25、ared by ISO/TC 172 “Optics and optical instruments” of the International Organization for Standardization, has been adopted by Technical Committee CEN/TC 170 “Ophthalmic optics”, the Secretariat of which is held by DIN, as a European Standard. This European Standard shall be given the status of a na

26、tional standard, either by publication of an identical text or by endorsement, at the latest by October 2001, and conflicting national standards shall be withdrawn at the latest by October 2001. In accordance with the CEN/CENELEC Internal Regulations, the national standards organizations of the foll

27、owing countries are bound to implement this European Standard: Austria, Belgium, the Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, the Netherlands, Norway, Portugal, Spain, Sweden, Switzerland, and the United Kingdom. Annexes A to E are for informati

28、on only. Endorsement notice The text of the International Standard ISO 14729:2001 was approved by CEN as a European Standard without any modification. !Foreword to EN ISO 14729:2001/A1:2010 This Amendment (EN ISO 14729:2001/A1:2010) has been prepared by Technical Committee ISO/TC 172 “Optics and pho

29、tonics” in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics”, the secretariat of which is held by DIN. This Amendment to the European Standard EN ISO 14729:2001 shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the

30、latest by April 2011, and conflicting national standards shall be withdrawn at the latest by April 2011. 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 s

31、uch patent rights. 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, France, Germany, Greece, Hungar

32、y, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of ISO 14729:2001/Amd. 1:2010 has been approved by CEN as EN ISO 14729:2001/A1:2010 wit

33、hout any modification.“ DIN EN ISO 14729:2011-01 EN ISO 14729:2001 + A1:2010 (E) 4 Introduction Products for contact lens disinfection by chemical means are intended to reduce microbial contamination introduced during lens wear and removal, cleaning and storage and are required to contain antimicrob

34、ial agents capable of achieving this. It is essential that all liquid contact lens care products are sterile until opened. Dry products (tablets, granules, etc.) should be subject to control of microbial contamination and should be dissolved in a suitable diluent immediately prior to use. Multidose

35、contact lens care products must be adequately preserved or be packaged in a container designed and labelled to minimize the risk of injury resulting from in-use contamination. Contact lenses are normally subject to a regimen of cleaning and contact lens disinfection between periods of wear. Aqueous

36、solutions containing cleaning and/or disinfecting agents are commonly used for this purpose. These products may be marketed as solutions or as tablets for dissolution immediately prior to use in a suitable diluent such as saline. The past 20 years of experience in the use and regulation of contact l

37、ens disinfecting products has shown distinct disinfecting antimicrobial criteria for this class of medical devices. Ocular toxicology concerns, process convenience and product comfort on the eye, have meant an evolution of products which maintain a low incidence of contact lens associated ocular inf

38、ection when used as instructed by the manufacturer. This International Standard gives these distinct contact lens disinfecting antimicrobial criteria along with annexes to explain why viruses (annex C) and Acanthamoeba (annex D) are not included as challenges. Organic soil is not required for evalua

39、tion of contact lens care disinfecting products but may be used; an informative annex (annex E) is included to discuss organic soil in the context of contact lenses and contact lens care products. DIN EN ISO 14729:2011-01 EN ISO 14729:2001 + A1:2010 (E) 51 Scope This International Standard specifies

40、 two test methods for evaluating the antimicrobial activity of products to be marketed for contact lens disinfection by chemical means and for products that are part of a contact lens care regimen. This International Standard is not applicable to the hygienic management of trial lenses. NOTE General

41、 disinfection product standards are not applicable to contact lens care products, e.g. EN 1040:1997 and EN 1275:1997. 2 Normative references The following normative documents contain provisions which, through reference in this text, constitute provisions of this International Standard. For dated ref

42、erences, subsequent amendments to, or revisions of, any of these publications do not apply. However, parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the normative documents indicated below. For undated r

43、eferences, the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of currently valid International Standards. !Deleted text“!Deleted text“ !ISO 18369-1, Ophthalmic optics Contact lenses Part 1: Vocabulary, classification system and recommen-dation

44、s for labelling specifications“ 3 Terms and definitions !Deleted text“ !For the purposes of this document, the terms and definitions given in ISO 18369-1 and the following apply.“ 3.1 contact lens disinfecting product product that possesses cidal activity (kills, destroys and/or inactivates) meeting

45、 the primary criteria of the stand-alone test specified in this International Standard 3.2 contact lens disinfecting regimen contact lens care regimen designed to meet both the secondary criteria of the stand-alone test and the regimen test as specified in this International Standard 3.3 contact len

46、s disinfection chemical or physical process to reduce the number of viable microorganisms as specified in the performance requirement sections of this International Standard DIN EN ISO 14729:2011-01 EN ISO 14729:2001 + A1:2010 (E) 6 4 Principle 4.1 General The stand-alone test is designed to qualify

47、 individual solutions with a suitable level of antimicrobial activity as contact lens disinfection products. The regimen test is designed to qualify individual solutions as part of a contact lens disinfecting regimen. Products meeting the regimen test criteria shall also meet the minimum performance

48、 requirements of the stand-alone test. It is fundamental that such products (unopened containers) are capable of meeting the requirements of the test throughout their labelled shelf life. As described in Figure 1, contact lens care solutions which are designed to possess disinfecting properties shal

49、l be tested in the stand-alone test first. If the respective primary criteria are met (see 5.1), the product may be labelled as a contact lens disinfecting product. If the product fails the primary criteria of the stand-alone test, the product must exhibit sufficient antimicrobial activity to meet the secondary criteria of the stand-alone test as listed in 5.2. If these secondary criteria are met, the regimen test shall be performed in order to qualify the product as part of a contact lens disinfecting regimen by meeting