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1、BRITISH STANDARD BS EN ISO 10344:1998 BS 7208-11: 1998 Optics and optical instruments Contact lenses Saline solution for contact lens testing The European Standard EN ISO 10344:1998 has the status of a British Standard ICS 11.040.70 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:00:57 GMT
2、+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 10344:1998 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 September 1998 BSI 05-1999 ISBN 0 580 30279 2
3、National foreword This British Standard is the English language version of EN ISO 10344:1998. It is identical with ISO 10344:1996. The UK participation in its preparation was entrusted by Technical Committee CH/78, Ophthalmic optics, to Subcommittee CH/78/4, Physical properties of contact lenses, wh
4、ich 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 promulgate th
5、em 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 corre
6、sponding European publications. The British Standards which implement international or European publications referred to in this document 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
7、Standards Electronic Catalogue. Additional information The formula given in clause 4.6 does not require a separate adjustment of pH. 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. Co
8、mpliance with a British Standard does not of itself confer immunity from legal obligations. Summary of pages This document comprises a front cover, an inside front cover, pages i and ii, the EN ISO title page, page 2, the ISO title page, page ii, pages 1 and 2, an inside back cover and a back cover.
9、 This standard has been updated (see copyright date) and may have had amendments incorporated. This will be indicated in the amendment table on the inside front cover. Amendments issued since publication Amd. No.DateComments Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:00:57 GMT+00:00 2
10、006, Uncontrolled Copy, (c) BSI BS EN ISO 10344:1998 BSI 05-1999i Contents Page National forewordInside front cover Foreword2 Forewordii Text of ISO 103441 Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:00:57 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii blank Licensed Copy: sheffieldun s
11、heffieldun, na, Wed Nov 15 13:00:57 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN ISO 10344 July 1998 ICS 11.040.70 Descriptors: See ISO document English version Optics and optical instruments Contact lenses Saline solution for contact lens testing (
12、ISO 10344:1996) Optique et instruments doptique Lentilles de contact Solution saline pour les essais des lentilles de contact (ISO 10344:1996) Optik und optische Instrumente Kontaktlinsen Kochsalzlsung fr die Prfung von Kontaktlinsen (ISO 10344:1996) This European Standard was approved by CEN on 22
13、June 1998. 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 bibliographical references concerning such national standards may be ob
14、tained on application to the Central Secretariat 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 of a CEN member into its own language and notified to the Central Se
15、cretariat has the same status as the official versions. CEN members are the national standards 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
16、 European Committee for Standardization Comit Europen de Normalisation Europisches Komitee fr Normung Central Secretariat: rue de Stassart 36, B-1050 Brussels 1998 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN ISO 10344:1998 E Li
17、censed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:00:57 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10344:1998 BSI 05-1999 2 Foreword The text of the International Standard from Technical Committee ISO/TC 172 “Optics and optical instruments” of the International Organization for Standard
18、ization (ISO) has been taken over as an European Standard by 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 an identical text or by endorsement, at the late
19、st by January 1999, and conflicting national standards shall be withdrawn at the latest by January 1999. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Austria, Belgium, Czech Republic,
20、 Denmark, Finland, France, Germany, Greece, Iceland, Ireland, Italy, Luxembourg, Netherlands, Norway, Portugal, Spain, Sweden, Switzerland and the United Kingdom. Endorsement notice The text of the International Standard ISO 10344:1996 was approved by CEN as a European Standard without any modificat
21、ion. NOTENormative references to International Standards are listed in Annex ZA (normative). Contents Page Foreword2 1Scope1 2Normative references1 3Definitions1 4Requirements1 5Preparation procedure2 Annex A (informative) BibliographyInside back cover Annex ZA (normative) Normative references to in
22、ternational publications with their corresponding European publicationsInside back cover Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:00:57 GMT+00:00 2006, Uncontrolled Copy, (c) BSI Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:00:57 GMT+00:00 2006, Uncontrolled Copy, (c) B
23、SI EN ISO 10344:1998 ii BSI 05-1999 Foreword ISO (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 technical committees. Each member body i
24、nterested 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 with the International Electrotechn
25、ical Commission (IEC) on all matters of electrotechnical standardization. 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 member bodies casting a vote.
26、 International Standard ISO 10344 was prepared by Technical Committee ISO/TC 172, Optics and optical instruments, Subcommittee SC 7, Ophthalmic optics and instruments. Annex A of this International Standard is for information only. Descriptors: Optics, optical equipment, ophthalmic equipment, contac
27、t lenses, tests, testing conditions, packaging, labelling. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:00:57 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10344:1998 BSI 05-19991 1 Scope This International Standard specifies a saline solution for use when conducting specified stand
28、ardized test methods to determine dimensional, physical, chemical and biological characteristics of contact lenses and contact lens materials. The specified solution is applicable to the equilibrating of either a contact lens or a contact lens material prior to testing, and also to the immersion of
29、the test item during testing. The specified solution is not intended for the purpose of packaging finished contact lenses but is similar to many commercially used contact lens packaging solutions. 2 Normative references The following standards contain provisions which, through reference in this text
30、, constitute provisions of this International 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 editi
31、ons of the standards indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 3696:1987, Water for analytical laboratory use Specification and test methods. ISO 8320:1986, Optics and optical instruments Contact lenses Vocabulary and symbols. 3 Defini
32、tions For the purposes of this International Standard, the definitions given in ISO 8320 apply. 4 Requirements 4.1 General The standard saline solution shall be phosphate buffered at a pH of 7,4 0,1 and have a nominal osmolarity of 310 mOsm/kg. 4.2 Ingredients The standard saline shall be prepared u
33、sing hydrated sodium phosphate salts which comply with the requirements of monographs in current official pharmacopoeia such as the US Pharmacopoeia (USP), the European Pharmacopoeia (Ph Eur) or various national pharmacopoeia. The liquid phase is water complying with ISO 3696:1987, grade 3 or any pu
34、rer standardized grade. Water shall be either freshly prepared or sterilized within 24 h of preparation of the standard solution. 4.3 Formulation in molarities The following molar concentrations shall be applicable to the finished solution. a) sodium chloride (NaCl) 1,420 101 M b) sodium dihydrogen
35、phosphate (NaH2PO4) 3,384 103 M c) disodium phosphate (Na2HPO4) 1,673 102 M 4.4 Formula example using USP substances a) sodium chloride USP (NaCl) 8,300 g b) monobasic sodium phosphate monohydrate USP (NaH2PO4H2O) 0,467 g c) dibasic sodium phosphate heptahydrate USP (Na2HPO47H2O) 4,486 g d) water ac
36、cording to ISO 3696:1987, grade 3 (H2O) qs 1 000 ml 4.5 Formula example using Ph Eur substances a) NATRII CHLORIDUM Ph Eur (NaCl) 8,300 g b) NATRII DIHYDROGENOPHOSPHAS DIHYDRICUS Ph Eur (NaH2PO42H2O) 0,528 g c) DINATRII PHOSPHAS DODECAHYDRICUS Ph Eur (Na2HPO412H2O) 5,993 g d) water according to ISO
37、3696:1987, grade 3 (H2O) qs 1 000 ml 4.6 Formula example using anhydrous substances NOTE 1As these are not all pharmacopoeial substances, this example is for information only. a)NaCl8,300 g b)NaH2PO40,406 g c)Na2HPO42,376 g d)H2O qs1 000 ml Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:0
38、0:57 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10344:1998 2 BSI 05-1999 5 Preparation procedure 5.1 General As the hydrated phosphates of sodium may vary in the number of molecules of water of hydration, depending on the type and period of exposure to the atmosphere and thus affecting their
39、formula mass, the formulations given in 4.4 to 4.6 may not achieve the required molarity and therefore the pH of 7,4 0,1. In this sense the saline is not a “standard” until provision has been made to adjust the solution using a standardized pH-meter with standardized reference solutions for calibrat
40、ion (e.g. BS 1647 and BS 3145). To adjust the solution, either aqueous orthophosphoric acid (e.g. 5 M) or aqueous sodium hydroxide (e.g. 5 M) should be added after the ingredients have been dissolved in the water. Only a small amount of adjustment (less than 1 ml/l) is normal. 5.2 Formulating the so
41、lution The three ingredients are sequentially added to 70 percent of the water (700 ml in the examples given in 4.4 to 4.6), ensuring that all are completely dissolved by proper mixing. This solution is tested with a standardized calibrated pH-meter and adjusted by dropwise addition of either acid o
42、r alkali (see 5.1) to a pH of 7,4 0,1. Dilute the adjusted solution with water to a volume of 1 000 ml, mix thoroughly and test the pH again. If necessary, add more acid or alkali. 5.3 Packaging and labelling If the saline is to be retained, it shall be packaged in autoclavable containers, preferabl
43、y of neutral glass, and sterilized by a validated process. The closures shall be airtight. Labelling shall include: a) reference to this International Standard (i.e. ISO 10344); b) a description (e.g. standard saline for contact lens testing); c) the date of preparation. If the saline is not to be s
44、tored, it shall be used within 24 h of preparation and need not be autoclaved. Licensed Copy: sheffieldun sheffieldun, na, Wed Nov 15 13:00:57 GMT+00:00 2006, Uncontrolled Copy, (c) BSI EN ISO 10344:1998 BSI 05-1999 Annex A (informative) Bibliography 1 BS 1647: pH measurement, Part 2:1984(1991), Spe
45、cification for reference value standard solutions and operational reference standard solutions. 2 BS 3145:1978(1993), Specification for laboratory pH meters. Annex ZA (normative) Normative references to international publications with their corresponding European publications This European Standard
46、incorporates by dated or undated references, provisions from other publications. These normative references are cited at the appropriate places in the text and the publications are listed hereafter. For dated references, subsequent amendments to or revisions of any of these publications apply to thi
47、s European Standard only when incorporated in it by amendment or revision. For undated references the latest edition of the publication referred to applies. PublicationYearTitleENYear ISO 36961987Water for analytical laboratory use Specification and test methods EN ISO 36961995 Licensed Copy: sheffi
48、eldun sheffieldun, na, Wed Nov 15 13:00:57 GMT+00:00 2006, Uncontrolled Copy, (c) BSI BS EN ISO 10344:1998 BS 7208-11: 1998 BSI 389 Chiswick High Road London W4 4AL BSI British Standards Institution BSI is the independent national body responsible for preparing British Standards. It presents the UK
49、view on standards in Europe and at the international level. It is incorporated by Royal Charter. Revisions British Standards are updated by amendment or revision. Users of British Standards should make sure that they possess the latest amendments or editions. It is the constant aim of BSI to improve the quality of our products and services. We would be grateful if anyone finding an inaccuracy or ambiguity while using this British Standard would inform the Secretary of the technical committee responsible, the ident