1、BSI Standards PublicationBS EN ISO 13212:2014Ophthalmic optics Contact lens care products Guidelines for determination ofshelf-lifeBS EN ISO 13212:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO13212:2014. It supersedes BS EN ISO 13212:2011 which is wit
2、hdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/172/9, Contact lenses and contact lens care products.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessarypr
3、ovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 79722 4ICS 11.040.70Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was publish
4、ed under the authority of theStandards Policy and Strategy Committee on 30 September 2014.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 13212 September 2014 ICS 11.040.70 Supersedes EN ISO 13212:2011English Version Ophthalmic optics - C
5、ontact lens care products - Guidelines for determination of shelf-life (ISO 13212:2014) Optique ophtalmique - Produits dentretien pour lentilles de contact - Lignes directrices pour la dtermination de la dure de conservation (ISO 13212:2014) Augenoptik - Kontaktlinsenpflegemittel - Leitfaden fr die
6、Bestimmung der Lagerdauer (ISO 13212:2014) This European Standard was approved by CEN on 14 May 2014. 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. U
7、p-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 tran
8、slation 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, Finla
9、nd, 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 STANDARDIZATIO
10、N COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG CEN-CENELEC Management Centre: Avenue Marnix 17, B-1000 Brussels 2014 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 13212:2014 EBS EN ISO 13212:2014EN ISO 13212:
11、2014 (E) 3 Foreword This document (EN ISO 13212:2014) 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 nat
12、ional standard, either by publication of an identical text or by endorsement, at the latest by March 2015, and conflicting national standards shall be withdrawn 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
13、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. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European
14、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
15、, 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 without any modification. BS EN ISO 13212:2014ISO 13212:2014(E) ISO 2014 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12
16、Normative references 13 Terms and definitions . 14 General requirements . 15 Determination of finished product stability 15.1 Objective . 15.2 Study methods . 25.3 Description of the product under study 35.4 Characteristics . 35.5 Evaluation methods 45.6 Presentation of results . 45.7 Discussion, in
17、terpretation, and conclusions . 45.8 Ongoing stability . 5Annex A (informative) Example of a stability testing plan for the finished contact lens care product 6Bibliography 7BS EN ISO 13212:2014ISO 13212:2014(E)ForewordISO (the International Organization for Standardization) is a worldwide federatio
18、n 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.
19、 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.The procedures used to develop this document and thos
20、e intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (s
21、ee www.iso.org/directives). 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. Details of any patent rights identified during the development of the doc
22、ument will be in the Introduction and/or on the ISO list of patent declarations received (see www.iso.org/patents). Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement.For an explanation on the meaning of ISO specific terms an
23、d expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 172, Optics and photonics, Subco
24、mmittee SC 7, Ophthalmic optics and instruments.This third edition cancels and replaces the second edition (ISO 13212:2011), which has been technically revised.iv ISO 2014 All rights reservedBS EN ISO 13212:2014ISO 13212:2014(E)IntroductionThe purpose of stability tests of contact lens care products
25、 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 quality of a contact lens care product is determined by its content of active ingredient(s), its pu
26、rity, 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 ascertain how the quality of a product varies as a function of time and under the influence of
27、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 safety, performance, and acceptability throughout the proposed shelf-life.The design of the finished
28、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. ISO 2014 All rights reserved vBS EN ISO 13212:2014BS EN ISO 13212:2014Ophthalmic optics Contact lens care products Guidelines for determination o
29、f shelf-life1 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 establis
30、h the in-use 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 unda
31、ted references, 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 Conta
32、ct lens care 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,
33、the terms and 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
34、assay for active 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 test
35、ing on contact 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 pr
36、operties of the 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.INTERNATIONAL STANDARD ISO 13212:2014(E) ISO 2014 All rights reserved 1BS EN ISO 13212:2014ISO 13212:2014(E)The specifications
37、 proposed from the time of manufacture to the end of the proposed shelf-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 Ge
38、neralBefore starting stability studies, a suitable testing plan should be 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 tes
39、t conditions, when applicable, which will enable the shelf-life and the 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
40、30 C to be evaluated. However, 25 C 2 C should be used as the mean kinetic 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
41、, low humidity conditions should be considered (see Annex A).For each study, 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,
42、 any changes that could significantly impact the safety and performance 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 Stu
43、dies under varying storage conditionsThese studies shall be carried out 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, i
44、f it occurs, is likely to be accelerated, producing useful data at an early 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 va
45、rious test conditions should be stated. Depending on the nature and objectives 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 m
46、ight need to be considered, such as below 15 C (freezer), 2 C to 8 C (refrigerator) 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,
47、 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;2 ISO 2014 All rights reservedBS EN ISO 13212:2014ISO 13212:2014(E)c) eleva
48、ted temperature and humidity in combination: e.g. temperature of 40 C associated with a relative humidity of up to 75 %, possibly with the effects of cycling between different temperatures and humidities;d) since most contact lens care products are water-based, relative humidity of 40 % or less (for
49、 example, 25 C and 40 % relative humidity) should be considered (see Annex A);e) light: either natural daylight or defined artificial illumination (see Annex A).5.3 Description of the product under study5.3.1 Number and nature of the batches testedThe number of batches tested shall be stated with the batch number, details of the composition, date of manufacture, size of the batch and the name of the manufacturer of the active ingredient(s) used. The material used for all packaging that can impact stability of the product shal
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