BS EN ISO 11979-6-2014 Ophthalmic implants Intraocular lenses Shelf-life and transport stability testing《眼科植入物 眼内透镜 贮藏寿命和运输稳定性试验》.pdf

1、BSI Standards PublicationBS EN ISO 11979-6:2014Ophthalmic implants Intraocular lensesPart 6: Shelf-life and transport stabilitytestingBS EN ISO 11979-6:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN ISO11979-6:2014. It supersedes BS EN ISO 11979-6:2007 whi

2、ch iswithdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/172/7, Eye implants.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. U

3、sers are responsible for its correctapplication. The British Standards Institution 2014. Published by BSI StandardsLimited 2014ISBN 978 0 580 76822 4ICS 11.040.70Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of

4、 theStandards Policy and Strategy Committee on 31 October 2014.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11979-6 October 2014 ICS 11.040.70 Supersedes EN ISO 11979-6:2007English Version Ophthalmic implants - Intraocular lenses - Par

5、t 6: Shelf-life and transport stability testing (ISO 11979-6:2014) Implants ophtalmiques - Lentilles intraoculaires - Partie 6: Dure de conservation et stabilit pendant le transport (ISO 11979-6:2014) Ophthalmische Implantate - Intraokularlinsen - Teil 6: Haltbarkeits- und Transportprfungen (ISO 119

6、79-6:2014)This European Standard was approved by CEN on 28 June 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. Up-to-date lists and bibliographi

7、cal 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 translation under the responsibility

8、 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, Finland, Former Yugoslav Republic of

9、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 STANDARDIZATION COMIT EUROPEN DE NORMALISATION

10、 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 11979-6:2014 EBS EN ISO 11979-6:2014EN ISO 11979-6:2014 (E) 3 Foreword This d

11、ocument (EN ISO 11979-6:2014) 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 national standard, either b

12、y publication of an identical text or by endorsement, at the latest by April 2015, and conflicting national standards shall be withdrawn at the latest by April 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 CENEL

13、EC shall not be held responsible for identifying any or all such patent rights. This document supersedes EN ISO 11979-6:2007. According to the CEN-CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Bel

14、gium, 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, Spain, Sweden, Switz

15、erland, Turkey and the United Kingdom. Endorsement notice The text of ISO 11979-6:2014 has been approved by CEN as EN ISO 11979-6:2014 without any modification. BS EN ISO 11979-6:2014ISO 11979-6:2014(E) ISO 2014 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative refe

16、rences 13 Terms and definitions . 14 Requirements 14.1 General . 14.2 Materials and methods 24.3 Product stability. 24.4 Package integrity . 44.5 Transport stability . 54.6 Results 55 Test methods and sampling 6Annex A (informative) Shelf-life study example . 7Annex B (informative) Tests for shelf-l

17、ife studies .10Bibliography .11BS EN ISO 11979-6:2014ISO 11979-6:2014(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 techn

18、ical 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. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely

19、with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization.The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria neede

20、d 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 (see www.iso.org/directives). Attention is drawn to the possibility that some of the elements of this document may be the subject of patent r

21、ights. 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 document 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

22、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 and expressions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers

23、 to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments.This third edition cancels and replaces the second edition (ISO 11979-6:2007), which has be

24、en technically revised.ISO 11979 consists of the following parts, under the general title Ophthalmic implants Intraocular lenses: Part 1: Vocabulary Part 2: Optical properties and test methods Part 3: Mechanical properties and test methods Part 4: Labelling and information Part 5: Biocompatibility P

25、art 6: Shelf-life and transport stability testing Part 7: Clinical investigations Part 8: Fundamental requirements Part 9: Multifocal intraocular lenses Part 10: Phakic intraocular lensesiv ISO 2014 All rights reservedBS EN ISO 11979-6:2014ISO 11979-6:2014(E)IntroductionThe purpose of a stability st

26、udy is to ascertain that the properties of a product, in this case an intraocular lens (IOL), remain within specified limits for a sufficiently long period of time under the influence of a variety of environmental conditions.The storage stability of the intraocular lens material is an important fact

27、or in the overall investigation of a new lens material, a new combination of given lens materials, a new packaging material, or a new manufacturing process. To assess this, a study of the ageing of the lenses in their containers is performed.Changes in the composition and material, material supplier

28、s, manufacturing conditions (including the sterilization process), or the package design or material could affect the shelf-life and could therefore necessitate renewed investigations. The need for studies of product stability, package integrity, and transport stability can be assessed using ISO 149

29、71.The design of the stability tests should be based on the known properties of the material from which the intraocular lens is made, and the recommendations for use of the intraocular lens. Knowledge of the quantity and identity of extractable substances found after storage or accelerated ageing st

30、udies are of importance in evaluating new intraocular lens materials.On the basis of the information obtained, transport and storage conditions can be recommended that will maintain the quality of the intraocular lens in relation to its safety, efficacy, and acceptability, throughout the proposed sh

31、elf-life, i.e. during storage and distribution up until the moment of dispensing. The results obtained are also used to determine the expiration date.In practical terms, it is the stability of the material from which the intraocular lens is made that is being tested, along with the integrity of the

32、packaging that maintains the necessary environment of the intraocular lens.Stability studies for intraocular lenses are thus material specific, i.e. this type of study need not be performed for more than one intraocular lens model for a given combination of IOL material(s), packaging materials, and

33、manufacturing processes. ISO 2014 All rights reserved vBS EN ISO 11979-6:2014BS EN ISO 11979-6:2014Ophthalmic implants Intraocular lenses Part 6: Shelf-life and transport stability testing1 ScopeThis part of ISO 11979 specifies tests by which the shelf-life of sterile intraocular lenses (IOLs) in th

34、eir final packaging can be determined. These tests include procedures to establish the stability of IOLs in distribution and storage.2 Normative referencesThe following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated re

35、ferences, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.ISO 11979-1, Ophthalmic implants Intraocular lenses Part 1: VocabularyISO 10993-5, Biological evaluation of medical devices Part 5: Tests for in vitro cy

36、totoxicityISO 10993-12, Biological evaluation of medical devices Part 12: Sample preparation and reference materialsISO 11607-1, Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systemsISO 11607-2, Packaging for terminally

37、sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processesISO 14971, Medical devices Application of risk management to medical devices3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 11979-1 apply.4 Requireme

38、nts4.1 GeneralIf, following a risk analysis in accordance with ISO 14971, it is found that a product stability study, a package integrity study, and/or a transport stability study are needed, this part of ISO 11979 shall apply to the planning and conduct of these studies.A study protocol shall be de

39、veloped prior to initiation of the study.The study results shall demonstrate that the parameters measured with regard to performance, safety, and product acceptability are within the finished product specifications, when available. In cases where there are no finished product specifications, then th

40、e parameters measured shall remain within the limits of the applicable parts of ISO 11979. If there exists neither finished product specifications nor applicable limits specified within ISO 11979, then a comparison to time zero product shall be performed.INTERNATIONAL STANDARD ISO 11979-6:2014(E) IS

41、O 2014 All rights reserved 1BS EN ISO 11979-6:2014ISO 11979-6:2014(E)In view of the fact that an intraocular lens may not have sufficient storage assessments accumulated by the time it is brought to the market, the results of accelerated tests (see 4.3.2) are acceptable for initial labelling purpose

42、s, i.e. to establish a shelf-life to be indicated on the product labelling. A maximum of five years of shelf-life can be claimed by a real-time study or an accelerated study regardless of material used in the intraocular lens. However, an accelerated study shall always be verified by a real-time stu

43、dy, and the real-time study results shall always take precedence over the accelerated study results. The same product or a Level A modification of it (see ISO/TR 22979) shall be used in the real-time study, and the real-time study shall be started before the release of the new intraocular lens into

44、the market.In case a manufacturer wishes to maintain the possibility of resterilizing finished intraocular lens lots, the finished intraocular lens lot(s) used in the stability study shall have undergone the maximum number of sterilization cycles allowed under the manufacturers procedures.4.2 Materi

45、als and methods4.2.1 Test samplesThe studies shall be performed using IOLs from finished intraocular lens lots. The proposed sample sizes are described in Annex A.4.2.2 MethodsSuitable methods shall be chosen for any tests contained in the study protocol. The methods selected shall be recorded. Anne

46、x B contains suggested tests. Due to the variation in product and package materials and design, other tests could be more appropriate. The methods selected, other than those specified in Annex B, shall be recorded and the details of validation for each test method, demonstrating the capability of th

47、e method, shall also be documented.In certain cases, more than one of the tests listed in Annex B can be performed on a single IOL, thereby reducing the total number of IOLs required.4.3 Product stability4.3.1 GeneralIf the risk analysis in accordance with ISO 14971 shows a need for a shelf-life stu

48、dy, the following shall apply. The rationale for choice of tests shall be documented in the risk management plan.For both real-time and accelerated testing, finished IOLs (or finished injector systems with IOLs) shall be used. For test parameters that can be affected by optical power, at least three

49、 groups, comprising lenses from one or more finished intraocular lens lots, shall be tested, one each from low, medium, and high dioptric power ranges, each group comprising one or more dioptric powers. For test parameters not affected by optical power, at least one group of lenses shall be used. See Annex A for guidance.4.3.2 Real-time shelf-life study4.3.2.1 Test parametersThe following parameters shall be considered:a) dimensions;b) dioptric power;c) imaging quality;d) surgical manipulation;2 ISO 2014 All rights reservedBS EN IS