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1、BRITISH STANDARD BS EN ISO 11987:1998 BS 7208-14: 1998 Incorporating Corrigendum No. 1 Ophthalmic optics Contact lenses Determination of shelf-life The European Standard EN ISO 11987:1997 has the status of a British Standard ICS 11.040.70 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:55:
2、11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 11987:1998 This British Standard, having been prepared under the direction of the Health and Environment Sector Board, was published under the authority of the Standards Board and comes into effect on 15 February 1998 BSI 04-1999 ISBN 0 580 291
3、07 3 National foreword This British Standard is the English language version of EN ISO 11987:1997. It is identical with ISO 11987:1997. The UK participation in its preparation was entrusted by Technical Committee CH/78, Ophthalmic optics, to Subcommittee CH/78/4, Physical properties of contact lense
4、s, which has the responsibility to: aid enquirers to understand the text; present to the responsible international/European committee any enquiries on the interpretation, or proposals for change, and keep the UK interests informed; monitor related international and European developments and promulga
5、te them in the UK. A list of organizations represented on this subcommittee can be obtained on request to its secretary. Cross-references Attention is drawn to the fact that CEN and CENELEC Standards normally include an annex which lists normative references to international publications with their
6、corresponding European publications. The British Standards which implement these international or European publications may be found in the BSI Standards Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Find” facility of the BSI Standards Electron
7、ic Catalogue. A British Standard does not purport to include all the necessary provisions of a contract. Users of British Standards are responsible for their correct application. Compliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This docum
8、ent comprises a front cover, an inside front cover, pages i and ii, the EN ISO title page, page 2, the ISO title page, pages ii to iv, pages 1 to 4 and a back cover. This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment
9、table on the inside front cover. Amendments issued since publication Amd. No.DateComments 9954 Corrigendum No. 1 March 1998 BS 7208-14:1997 corrected to BS 7208-14:1998 on the front and back cover Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:55:11 GMT+00:00 2006, Uncontrolled Copy, (c)
10、BSI BS EN ISO 11987:1998 BSI 04-1999i Contents Page National forewordInside front cover Foreword2 Forewordiii Text of EN ISO 119871 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:55:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii blank Licensed Copy: sheffieldun sheffieldun, na, Wed Nov
11、15 12:55:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 11987 December 1997 ICS 11.040.70 Descriptors: See ISO document English version Optics and optical instruments Contact lenses Determination of shelf-life (ISO 11987-1997) Optique et instru
12、ments doptique Lentilles de contact Dtermination de la dure de conservation (ISO 11987:1997) Augenoptik Kontaktlinsen Bestimmung der Lagerdauer (ISO 11987:1997) This European Standard was approved by CEN on 30 October 1997. CEN members are bound to comply with the CEN/CENELEC Internal Regulations wh
13、ich 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 Central Secretariat or to any CEN member. This European St
14、andard 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 Central Secretariat has the same status as the official versions. CEN members are the national st
15、andards bodies of Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and United Kingdom. CEN European Committee for Standardization Comit Europen de Normalisation Europisches Komi
16、tee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1997 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 11987:1997 E Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:55:11 GMT+00:00 2006, Uncontrol
17、led Copy, (c) BSI EN ISO 11987:1997 BSI 04-1999 2 Foreword The text of the International Standard ISO 11987 has been prepared by Technical Committee ISO/TC 172 “Optics and optical instruments” in collaboration with Technical Committee CEN/TC 170 “Ophthalmic optics”, the secretariat of which is held
18、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 June 1998, and conflicting national standards shall be withdrawn at the latest by June 1998. According to the CEN/CENELEC Internal Regulatio
19、ns, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic, Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the Unite
20、d Kingdom. Endorsement notice The text of the International Standard ISO 11987:1997 was approved by CEN as a European Standard without any modification. NOTENormative references to International Standards are listed in Annex ZA (normative). A-deviations are given in Annex ZB (informative). Licensed
21、Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:55:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:55:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 11987:1997 ii BSI 04-1999 Contents Page Forewordiii Introduction1 1Scope1 2Normative ref
22、erences1 3Principle1 4Reagent1 5Apparatus1 6Test samples2 7Test procedure2 8Presentation of results3 9Test report3 Annex A (informative) Bibliography4 Annex ZA (normative) Normative references to international publications with their relevant European publications4 Annex ZB (informative) A-deviation
23、s4 Table 1 Suitable parameters for test lenses2 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:55:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 11987:1997 BSI 04-1999iii Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standard
24、s 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. International organiz
25、ations, 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. Draft International Standards adopted by the technical committees are circ
26、ulated to the member bodies for voting. Publication as an International Standard requires approval by at least 75 % of the member bodies casting a vote. International Standard ISO 11987 was prepared by ISO/TC 172, Optics and optical instruments, Subcommittee SC 7, Ophthalmic optics and instruments.
27、Annex A of this International Standard is for information only. Descriptors: Optics, optical equipment, ophthalmic equipment, contact lenses, tests, determination, stability, shelf-life. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:55:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv bla
28、nk Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:55:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 11987:1997 BSI 04-19991 Introduction The tests included in this International Standard are designed to obtain information that will enable proposals to be made for the shelf-life of t
29、he contact lens, and enable storage conditions to be recommended. However in practical terms it is the stability of the material from which the 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 purp
30、ose 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 variety of environmental factors. On the basis of the information thus obtained, storage conditions can be recommended which will guarantee the maintenance of th
31、e quality of the contact lens in relation to its safety, efficacy and acceptability, throughout the proposed shelf-life (i.e. during storage and distribution until the moment of dispensing). 1 Scope This International Standard describes the testing required in order to determine the stability of con
32、tact lenses, once placed in their final packaging, during storage and distribution. NOTEThe results obtained can be used for determining the “expiry date”. 2 Normative references The following standards contain provisions which, through reference in this text, constitute provisions of this Internati
33、onal Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this International Standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Mem
34、bers of IEC and ISO maintain registers of currently valid International Standards. ISO 8321-1:1991, Optics and optical instruments Contact lenses Part 1: Specification for rigid corneal and scleral contact lenses. ISO 8599:1994, Optics and optical instruments Contact lenses Determination of spectral
35、 and luminous transmittances. ISO 9337-1:1), Ophthalmic optics Contact lenses Determination of back vertex power Part 1: Focimeter. ISO 9338:1996, Optics and optical instruments Contact lenses Determination of the diameters. ISO 9341:1996, Optics and optical instruments Contact lenses Determination
36、of inclusions and surface imperfections for rigid contact lenses. ISO 10338:1996, Optics and optical instruments Contact lenses Determination of curvature. 3 Principle Suitable tests are described by which the stability of contact lenses under controlled storage conditions is established and their s
37、helf-life under those conditions determined. The design of the stability tests is based on the known properties of the material from which the contact lens is made, and the recommendations for storage of the contact lens. NOTE 1A knowledge of the quantity and identity of extractable substances (see
38、ISO 10340) is of particular help in evaluating new contact lens materials, and in determining the information that needs to be obtained from the stability testing. NOTE 2The specifications claimed at the time of manufacture and to the end of the proposed shelf-life should reflect, as far as possible
39、, the results of the stability studies, particularly in relation to any parameters which could have a bearing on efficacy, safety and product acceptability. NOTE 3In designing stability tests, the manufacturer should consider any sterility requirement. Validation and requirements of sterilization pr
40、ocesses are described in other International Standards. Additionally, sterility testing is described in pharmacopoeia monographs. 4 Reagent The reagent shall be the contact lens storage solution used by the manufacturer for packing the contact lens. 5 Apparatus 5.1 Controlled storage chamber, capabl
41、e of being maintained at 25 C 2 C, and equipped with means for continuously recording temperature and humidity. NOTEAdditional storage conditions, for example at 35 C 2 C and 45 C 2 C, may be required for accelerated studies. 5.2 Measuring equipment, as required, for the determination of back vertex
42、 power, total diameter, curvature and spectral transmittance. The equipment shall incorporate, if necessary, the facility to condition the contact lens within the storage solution before and during measurement, under the controlled conditions specified in the measurement method. 1) To be published.
43、Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 12:55:11 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 11987:1997 2 BSI 04-1999 Table 1 Suitable parameters for test lenses 6 Test samples 6.1 Test lenses shall be representative of the normal production. The parameters of the contact lenses
44、 being studied shall be representative of the range of parameters normally produced, in particular high and low back vertex powers (see Table 1). If supplied sterile, the contact lenses shall have been subjected to the sterilization process normally used. 6.2 The contact lenses to be studied shall b
45、e randomly selected from not less than two different batches of the contact lens polymer, preferably from production-scale manufacture. NOTEIn practice, a manufacturer would normally have some stability data from contact lenses made from small-scale or research lots of polymer. The examination of th
46、e data may indicate that more than two batches should be selected for this stability study. 6.3 The contact lenses shall be packaged in the same manner as that intended when supplied to the purchaser. For contact lenses that are supplied sterile, the package is required to maintain the sterility unt
47、il opened, or until the shelf-life has expired. NOTE 1The usual limitations on shelf-life are the permeability of the package to moisture and the sensitivity of the contact lens parameters to change in degree of hydration and/or salinity. A packaging failure is the most common cause of a shortened s
48、helf-life. Therefore sufficient contact lenses should be placed on test to clearly differentiate between a material instability and a packaging failure. NOTE 2There is a possibility that substances could be extracted from the packaging itself and that these might interfere with the safety or perform
49、ance of contact lenses. The manufacturer should recognize this possibility when selecting the packaging materials and either carry out suitable testing or use packaging that meets a relevant national or international specification or a specification of a National Pharmacopoeia. 7 Test procedure 7.1 Real-time studies 7.1.1 Measure and record the initial parameters of the contact lenses under test (see clause 6) and identify each contact lens with a unique number upon the contact lens packaging. 7.1.2 Tran