1、December 2014 Translation by DIN-Sprachendienst.English price group 10No 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).I
2、CS 11.040.70!%e;“2276624www.din.deDDIN EN ISO 13212Ophthalmic optics Contact lens care products Guidelines for determination of shelf-life (ISO 13212:2014);English version EN ISO 13212:2014,English translation of DIN EN ISO 13212:2014-12Augenoptik Kontaktlinsenpflegemittel Leitfaden fr die Bestimmun
3、g der Lagerdauer (ISO 13212:2014);Englische Fassung EN ISO 13212:2014,Englische bersetzung von DIN EN ISO 13212:2014-12Optique ophtalmique Produits dentretien pour lentilles de contact Lignes directrices pour la dtermination de la dure de conservation (ISO 13212:2014);Version anglaise EN ISO 13212:2
4、014,Traduction anglaise de DIN EN ISO 13212:2014-12SupersedesDIN EN ISO 13212:2011-08www.beuth.deDocument comprises 15 pagesIn case of doubt, the German-language original shall be considered authoritative.11.14 DIN EN ISO 13212:2014-12 2 A comma is used as the decimal marker. National foreword This
5、document (EN ISO 13212:2014) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics”, Subcommittee SC 7 “Ophthalmic optics and instruments” in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics” (both secretariats are held by DIN, Germany). The responsible German
6、 body involved in its preparation was the DIN-Normenausschuss Feinmechanik und Optik (DIN Standards Committee Optics and Precision Mechanics), Working Committee NA 027-01-08 AA Augenoptik, Working Group NA 027-01-08-04 AK Kontaktlinsen. The DIN Standards corresponding to the International Standards
7、referred to in this document are as follows: ISO 14534 DIN EN ISO 14534 ISO 14729 DIN EN ISO 14729 ISO 14730 DIN EN ISO 14730 ISO 18369-1 DIN EN ISO 18369-1 Amendments This standard differs from DIN EN ISO 13212:2011-08 as follows: a) requirements concerning the relative humidity during the test hav
8、e been rendered more precise; b) a description of the number and nature of the batches tested has been included (5.3.1): The material used for all packaging that can impact stability of the product is to be stated; c) Annex A (informative): the examples have been brought in line with the revised req
9、uirements concerning the relative humidity and references to relevant ICH documents have been added; d) the text of the revised version ISO 13212:2014 has been adopted in its entirety. Previous editions DIN EN ISO 13212: 1997-07, 2011-08 DIN EN ISO 13212:2014-12 3 National Annex NA (informative) Bib
10、liography DIN EN ISO 14534, Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements DIN EN ISO 14729, Ophthalmic optics Contact lens care products Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses DIN EN
11、 ISO 14730, Ophthalmic optics Contact lens care products Antimicrobial preservative 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 DIN EN ISO 183
12、69-2, Ophthalmic optics Contact lenses Part 2: Tolerances DIN EN ISO 18369-3 Ophthalmic optics Contact lenses Part 3: Measurement methods DIN EN ISO 18369-4 Ophthalmic optics Contact lenses Part 4: Physicochemical properties of contact lens materials DIN EN ISO 13212:2014-12 4 This page is intention
13、ally blank EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13212 September 2014 ICS 11.040.70 Supersedes EN ISO 13212:2011English Version Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life (ISO 13212:2014) Optique ophtalmique - Produits dentretien po
14、ur lentilles de contact - Lignes directrices pour la dtermination de la dure de conservation (ISO 13212:2014) Augenoptik - Kontaktlinsenpflegemittel - Leitfaden fr die Bestimmung der Lagerdauer (ISO 13212:2014) This European Standard was approved by CEN on 14 May 2014. CEN members are bound to compl
15、y 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
16、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 sam
17、e 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,
18、 Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 201
19、4 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 13212:2014 EContents PageForeword 3Introduction 41 Scope . 52 Normative references 53 Terms and definitions . 54 General requirements . 55 Determination of finished product stab
20、ility 55.1 Objective .55.2 Study methods .65.3 Description of the product under study 75.4 Characteristics . 75.5 Evaluation methods 85.6 Presentation of results .85.7 Discussion, interpretation, and conclusions .85.8 Ongoing stability . 9Annex A (informative) Example of a stability testing plan for
21、 the finished contact lens care product 10Bibliography . 11DIN EN ISO 13212:2014-12 EN ISO 13212:2014 (E) 2 DIN EN ISO 13212:2014-12 EN ISO 13212:2014 (E) 3Foreword This document (EN ISO 13212:2014) has been prepared by Technical Committee ISO/TC 172 “Optics and photonics” in collaboration with Tech
22、nical 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 March 2015, and conflicting national standards shall be with
23、drawn at the latest by March 2015. 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 13212:2011. Accordi
24、ng 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, G
25、reece, 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 13212:2014 has been approved by CEN as EN ISO 13212:2014 wi
26、thout any modification. IntroductionThe purpose of stability tests of contact lens care products is to obtain sufficient information to enable the manufacturer to establish an appropriate shelf-life and identify any unique storage conditions required to appear on the labelling of the product.The qua
27、lity of a contact lens care product is determined by its content of active ingredient(s), its purity, and its physicochemical and microbiological properties. It is important to take into account the possible interaction of the container/closure with the contents.The stability studies are intended to
28、 ascertain how the quality of a product varies as a function of time and under the influence of a variety of environmental factors.On the basis of the information obtained, storage conditions are recommended, which will guarantee the maintenance of the quality of the product in relation to its safet
29、y, performance, and acceptability throughout the proposed shelf-life.The design of the finished product stability studies for a care product is based on the knowledge obtained from studies on the active ingredient(s) and from the development studies.DIN EN ISO 13212:2014-12 EN ISO 13212:2014 (E) 4 1
30、 ScopeThis International Standard provides guidance on the design of stability studies for use in gathering information to enable determination of the shelf-life of contact lens care products.This International Standard does not address studies designed to obtain information to establish the in-use
31、stability (i.e. notice of discard date) of contact lens care products.2 Normative referencesThe 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 reference
32、s, the latest edition of the referenced document (including any amendments) applies.ISO 14729, Ophthalmic optics Contact lens care products Microbiological requirements and test methods for products and regimens for hygienic management of contact lensesISO 14730, Ophthalmic optics Contact lens care
33、products Antimicrobial preservative efficacy testing and guidance on determining discard dateISO 18369-1, Ophthalmic optics Contact lenses Part 1: Vocabulary, classification system and recommendations for labelling specifications3 Terms and definitionsFor the purposes of this document, the terms and
34、 definitions given in ISO 18369-1 apply.4 General requirements4.1 The specified shelf-life of the contact lens care product shall be based on the evaluation of the results of stability studies.4.2 Analytical methods that have been validated and are stability indicating shall be used to assay for act
35、ive ingredients. Validation includes, but is not limited to, being able to differentiate between the active ingredient and its degradation products. The test methods used shall be described in full.5 Determination of finished product stability5.1 ObjectiveThe objective of stability testing on contac
36、t lens care products is to provide data for determining the time period during which the product performance characteristics are maintained and to define appropriate storage conditions.The design of the stability tests is based on the known properties of the active ingredient(s), the properties of t
37、he chosen formulation, and the recommendations for use of the product.The relevant assay methods shall be determined prior to the start of the stability testing.DIN EN ISO 13212:2014-12 EN ISO 13212:2014 (E) 5 The specifications proposed from the time of manufacture to the end of the proposed shelf-
38、life shall reflect, as far as possible, the results of the stability studies, particularly in relation to any parameters which could have a bearing on performance and safety and on product acceptability.5.2 Study methods5.2.1 GeneralBefore starting stability studies, a suitable testing plan should b
39、e set up, taking into consideration the properties of the active ingredient(s) as well as the proposed mode of action of the care product.5.2.2 Real-time studiesThese studies should be carried out under a range of controlled test conditions, when applicable, which will enable the shelf-life and the
40、storage requirements which are to appear on the product container label/package insert to be defined. This will normally include studies which are intended to allow the properties of the product at temperatures between 20 C and 30 C to be evaluated. However, 25 C 2 C should be used as the mean kinet
41、ic testing temperature.Relative humidity should be controlled for all products that are not in hermetically sealed containers. In the case of tablets, high humidity conditions should be considered. In the case of aqueous liquids, low humidity conditions should be considered (see Annex A).For each st
42、udy, the mean temperature, the ranges of temperature, and mean humidity, if applicable, shall be stated in the stability report.These studies are intended to support the initial shelf-life request and, for shelf-life extensions, any changes that could significantly impact the safety and performance
43、of the product (e.g. certain changes in formulation, packaging materials, or manufacturing methods).NOTE Real-time studies are performed in conjunction with accelerated ageing studies to establish an initial shelf-life.5.2.3 Studies under varying storage conditionsThese studies shall be carried out
44、to provide important additional information. They can fulfil a number of objectives, such as supporting the initial shelf-life request, by complementing the limited results of the early real-time studies because decomposition, if it occurs, is likely to be accelerated, producing useful data at an ea
45、rly stage of development, demonstrating the effects of adverse storage in the packaging and product, and enabling storage conditions and suitable labelling to be provided, and supporting a request to extend the shelf-life.The various test conditions should be stated. Depending on the nature and obje
46、ctives of the stability study, the following points might need to be considered:a) various test temperatures: three or more, particularly if long-term real-time data are unavailable. In addition, the effect of low temperatures might need to be considered, such as below 15 C (freezer), 2 C to 8 C (re
47、frigerator) and freezethaw cycling;b) high humidity: relative humidity up to 75 % 5 % (see Annex A). Storage under high humidity conditions applies particularly to solid dosage forms. For products such as solutions, suspensions, etc. contained in packs designed to provide a permanent barrier to water loss, storage under high humidity is not necessary. However, low humidity can have an adverse effect on products packaged in semi-permeable containers;DIN EN ISO 13212:2014-12 EN ISO 13212:2014 (E) 6
