EN ISO 11987-2012 en Ophthalmic optics - Contact lenses - Determination of shelf-life《眼科光学 接触镜 储存寿命的测定》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN ISO 11987:2012Ophthalmic optics Contactlenses Determination ofshelf-life (ISO 11987:2012)BS EN ISO 11987:2012 BRITISH STANDARDNational forewordThis British Standard is the

2、UK implementation of EN ISO11987:2012. It supersedes BS EN ISO 11987:1998 which is withdrawn.The UK participation in its preparation was entrusted to TechnicalCommittee CH/172/9, Contact lenses and contact lens care products.A list of organizations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 req

3、uest to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for its correctapplication. The British Standards Institution 2012. Published by BSI StandardsLimited 2012ISBN 978 0 580 66351 2ICS 11.040.70Compliance with a British S

4、tandard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 July 2012.Amendments issued since publicationDate Text affectedEUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11987 July 2012 ICS

5、 11.040.70 Supersedes EN ISO 11987:1997English Version Ophthalmic optics - Contact lenses - Determination of shelf-life (ISO 11987:2012) Optique ophtalmique - Lentilles de contact - Dtermination de la dure de conservation (ISO 11987:2012) Augenoptik - Kontaktlinsen - Bestimmung der Lagerdauer (ISO 1

6、1987:2012) This European Standard was approved by CEN on 14 July 2012. 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 bibliograph

7、ical 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 responsibilit

8、y 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 NORMALISATIO

10、N EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2012 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11987:2012: EBS EN ISO 11987:2012EN ISO 11987:2012 (E) 3 Foreword This document (EN ISO

11、11987:2012) 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 by publication of a

12、n identical text or by endorsement, at the latest by January 2013, and conflicting national standards shall be withdrawn at the latest by January 2013. 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 b

13、e held responsible for identifying any or all such patent rights. This document supersedes EN ISO 11987:1997. 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,

14、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, Switzerland, Turkey a

15、nd the United Kingdom. Endorsement notice The text of ISO 11987:2012 has been approved by CEN as a EN ISO 11987:2012 without any modification. BS EN ISO 11987:2012ISO 11987:2012(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies

16、(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. International organizations, g

17、overnmental 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.International Standards are drafted in accordance with the rules given in the ISO/IE

18、C Directives, Part 2.The main task of technical committees is to prepare International Standards. Draft International Standards adopted by the technical committees are circulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the membe

19、r bodies casting a vote.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.ISO 11987 was prepared by Technical Committee ISO/TC 172, Optics and photonics

20、, Subcommittee SC 7, Ophthalmic optics and instruments.This second edition cancels and replaces the first edition (ISO 11987:1997), which has been technically revised. It also incorporates the Technical Corrigendum ISO 11987:1997/Cor.1:1998. ISO 2012 All rights reserved iiiBS EN ISO 11987:2012ISO 11

21、987:2012(E)IntroductionThe tests included in this International Standard are designed to obtain information that enables proposals to be made for the shelf-life of a contact lens, and storage conditions to be recommended. However, in practical terms, it is the stability of the material from which th

22、e contact lens is made that is being tested, along with the integrity of the packaging that maintains the environment necessary for the contact lens.The purpose of the stability studies is to ascertain how the quality of the contact lens varies as a function of time and under the influence of a vari

23、ety of environmental factors. On the basis of the information thus obtained, storage conditions can be recommended that guarantee the maintenance of the quality of the contact lens in relation to its safety, efficacy and acceptability throughout the proposed shelf-life (i.e. during storage and distr

24、ibution until the moment of dispensing).iv ISO 2012 All rights reservedBS EN ISO 11987:2012Ophthalmic optics Contact lenses Determination of shelf-life1 ScopeThis International Standard specifies test procedures for determining the stability of contact lenses once they are placed in their final pack

25、aging during storage and distribution.NOTE The results obtained can be used for determining the expiry date.2 Normative referencesThe following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, t

26、he latest edition of the referenced document (including any amendments) applies.ISO 18369-1, Ophthalmic optics Contact lenses Part 1: Vocabulary, classification system and recommendations for labelling specificationsISO 18369-2, Ophthalmic optics Contact lenses Part 2: TolerancesISO 18369-3, Ophthal

27、mic optics Contact lenses Part 3: Measurement methods3 Terms and definitionsFor the purposes of this document, the terms and definitions given in ISO 18369-1 apply.4 PrincipleThe stability of contact lenses, packaging solution and packaging is established under controlled storage conditions in order

28、 to determine their shelf-life under those conditions.The design of the stability tests is based on the known properties of the material from which the contact lens is made, the packaging system, and the recommendations for storing the contact lens.5 General requirements and recommendationsA risk as

29、sessment shall be performed to evaluate the critical properties and parameters, and a test protocol prepared.NOTE 1 A knowledge of the quantity and identity of extractable substances (see ISO 18369-4) is of particular help in evaluating new contact lens materials and in determining the information t

30、hat needs to be obtained from the stability testing.The specifications of the properties and parameters evaluated in the stability study, which are claimed at the time of manufacture and to the end of the proposed shelf-life, should reflect, as far as possible, the results of the stability studies,

31、particularly in relation to any parameters which could have a bearing on efficacy, safety and product acceptability.In designing stability tests, the manufacturer should consider any sterility requirements.NOTE 2 Requirements for the development, validation and routine control of sterilization proce

32、sses are described in other International Standards. Additionally, sterility testing is described in monographs in various pharmacopoeias.INTERNATIONAL STANDARD ISO 11987:2012(E) ISO 2012 All rights reserved 1BS EN ISO 11987:2012ISO 11987:2012(E)6 Test and measurement media6.1 The test medium shall

33、be the contact lens storage solution, if any, that is used by the manufacturer for packaging the contact lens.6.2 Measurements shall be made either in the test medium (packaging solution), or in the standard saline solution specified in ISO 18369-3 after equilibration in this solution, or dry. The s

34、ame measurement medium shall be used at all test stages. The choice of measurement medium shall be discussed in the risk assessment and test protocol.7 Apparatus7.1 Controlled storage chamber, capable of being maintained at 25 C 2 C, and equipped with means for continuously recording temperature and

35、 humidity.Additional storage conditions, for example at 35 C 2 C and 45 C 2 C, may be required for accelerated studies.Low relative humidity, for example 10 % RH to 20 % RH, can adversely affect products packed in semi-permeable containers; consideration should be given to appropriate testing under

36、such conditions.7.2 Lens/lens packaging measuring equipment, as required, for the determination of back vertex power, total diameter, curvature, spectral transmittance and other parameters of the lens and packaging system (to be determined from the risk assessment). The equipment shall incorporate,

37、if necessary, the ability to condition the contact lens within the measurement media before and during measurement, under the controlled conditions specified in the measurement method.7.3 Solution measuring equipment, as required, to measure the properties of the packaging solution (to be determined

38、 from the risk assessment).8 Test samples8.1 Test lenses shall be representative of the normal production. The parameters of the contact lenses being studied shall be representative of the range of parameters normally produced, in particular high and low back vertex powers. Additional properties, e.

39、g. ultraviolet light transmittance, shall be considered for measurement, depending on the nature of the contact lens and the outcome of the risk assessment. If supplied sterile, the contact lenses shall have been subjected to the sterilization process that has been validated.When contact lenses are

40、made by moulding or casting, the back vertex powers available are frequently limited to the range 0 D to -5 D during initial production runs. In these cases, the stability study should test contact lenses of the extreme back vertex powers available. If the back vertex power range is later increased,

41、 an additional risk assessment should be conducted which utilizes the data from the existing study to determine whether the stability study should be continued with contact lenses from the extreme back vertex powers of the new production range.The selection of power ranges may be adjusted to the req

42、uirements of specific test methods.8.2 The contact lenses to be studied shall be randomly selected from not less than two different traceable batches of the contact lens polymer, preferably from production scale manufacture.NOTE In practice, a manufacturer would normally have some stability data fro

43、m contact lenses made from small-scale or research lots of polymer. The examination of the data can indicate the need to select more than two batches for this stability study.2 ISO 2012 All rights reservedBS EN ISO 11987:2012ISO 11987:2012(E)8.3. The contact lenses shall be packaged in the same mann

44、er as that intended when supplied to the purchaser. For contact lenses that are supplied sterile, the package shall maintain the sterility until opened, or until the shelf-life has expired.There is a possibility that substances might be extracted from the packaging itself and that these might interf

45、ere with the safety or performance of the contact lenses. The manufacturer should recognize this possibility when selecting the packaging materials and either carry out a risk assessment, perform suitable testing, or use packaging that meets a relevant national or international specification or a sp

46、ecification of a national pharmacopoeia.8.4 The stability of the packaging solution shall also be monitored. The parameters monitored shall be those included in the solution specification (e.g. pH, osmolality), and additional ingredients added for performance and/or label claims.The usual limitation

47、s on shelf-life are the permeability of the package to moisture and the sensitivity of the parameters of the contact lens to change in the degree of hydration and/or salinity. A packaging failure is a common cause of a shortened shelf-life. Therefore, sufficient contact lenses should be tested to cl

48、early differentiate between a material instability and a packaging failure.9 Test procedure9.1 Real-time studies9.1.1 Measure and record the initial properties, parameters and solution properties of a sufficient number of contact lenses from each test lot. Identify each test lot with a unique identi

49、fier. Each lens should be traceable with respect to identity and source through the lot number or unique identifier.Sufficient samples from each lot should be stored in a controlled storage chamber and conditioned (see 7.2) to allow the measurement of properties and parameters at designated time intervals. The parameters and properties from these representative samples are used to determine stability.Additional properties, for example ultraviolet-light transmittance, should be considered for measurement, depending on the nature of the