BS EN ISO 13212-2014 Ophthalmic optics Contact lens care products Guidelines for determination of shelf-life《眼科光学 隐形眼镜护理产品 镜架寿命测定指南》.pdf
《BS EN ISO 13212-2014 Ophthalmic optics Contact lens care products Guidelines for determination of shelf-life《眼科光学 隐形眼镜护理产品 镜架寿命测定指南》.pdf》由会员分享,可在线阅读,更多相关《BS EN ISO 13212-2014 Ophthalmic optics Contact lens care products Guidelines for determination of shelf-life《眼科光学 隐形眼镜护理产品 镜架寿命测定指南》.pdf(18页珍藏版)》请在麦多课文档分享上搜索。
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
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