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1、DRAFT FOR DEVELOPMENT DD ISO/TS 19979:2004 Ophthalmic optics Contact lenses Hygienic management of multipatient use trial contact lenses ICS 11.040.70 ? Licensed Copy: London South Bank University, London South Bank University, Sun Dec 10 13:26:19 GMT+00:00 2006, Uncontrolled Copy, (c) BSI DD ISO/TS
2、 19979:2004 This Draft for Development was published under the authority of the Standards Policy and Strategy Committee and comes into effect on 14 November 2005 BSI 14 November 2005 ISBN 0 580 46812 7 National foreword This Draft for Development reproduces verbatim ISO/TS 19979:2004. This publicati
3、on is not to be regarded as a British Standard. It is being issued in the Draft for Development series of publications and is of a provisional nature because the document may form the basis of a full ISO standard in due course. It should be applied on this provisional basis, so that information and
4、experience of its practical application may be obtained. Comments arising from the use of this Draft for Development are requested so that UK experience can be reported to the international organization responsible for the Technical Specification. A review of this publication will be initiated not l
5、ater than 3 years after its publication by the international organization so that a decision can be taken on its status at the end of its 3-year life. Notification of the start of the review period will be made in an announcement in the appropriate issue of Update Standards. According to the replies
6、 received by the end of the review period, the responsible BSI Committee will decide whether to support the conversion into an international standard, to extend the life of the Technical Specification for another 3 years or to withdraw it. Comments should be sent in writing to the Secretary of BSI T
7、echnical Committee CH/172, Ophthalmic optics, at British Standards House, 389 Chiswick High Road, London W4 4AL, giving the document reference and clause number and proposing, where possible, an appropriate revision of the text. A list of organizations represented on this committee can be obtained o
8、n request to its secretary. Cross-references The British Standards which implement international publications referred to in this document may be found in the BSI Catalogue under the section entitled “International Standards Correspondence Index”, or by using the “Search” facility of the BSI Electro
9、nic Catalogue or of British Standards Online. This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. Summary of pages This document comprises a front cover, an inside front cover, the ISO/TS title page, pages ii to
10、iv, pages 1 to 7 and a back cover. The BSI copyright notice displayed in this document indicates when the document was last issued. Amendments issued since publication Amd. No. DateComments Licensed Copy: London South Bank University, London South Bank University, Sun Dec 10 13:26:19 GMT+00:00 2006,
11、 Uncontrolled Copy, (c) BSI Reference number ISO/TS 19979:2004(E) TECHNICAL SPECIFICATION ISO/TS 19979 First edition 2004-02-01 Ophthalmic optics Contact lenses Hygienic management of multipatient use trial contact lenses Optique ophtalmique Lentilles de contact Entretien de lhygine des lentilles de
12、 contact dessai usage multipatient DD ISO/TS 19979:2004 Licensed Copy: London South Bank University, London South Bank University, Sun Dec 10 13:26:19 GMT+00:00 2006, Uncontrolled Copy, (c) BSI ii Licensed Copy: London South Bank University, London South Bank University, Sun Dec 10 13:26:19 GMT+00:0
13、0 2006, Uncontrolled Copy, (c) BSI iii 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 bod
14、y 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 with the International Electrote
15、chnical Commission (IEC) on all matters of electrotechnical standardization. International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2. The main task of technical committees is to prepare International Standards. Draft International Standards adopted by
16、 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. In other circumstances, particularly when there is an urgent market requirement for such documents, a technical c
17、ommittee may decide to publish other types of normative document: an ISO Publicly Available Specification (ISO/PAS) represents an agreement between technical experts in an ISO working group and is accepted for publication if it is approved by more than 50 % of the members of the parent committee cas
18、ting a vote; an ISO Technical Specification (ISO/TS) represents an agreement between the members of a technical committee and is accepted for publication if it is approved by 2/3 of the members of the committee casting a vote. An ISO/PAS or ISO/TS is reviewed after three years in order to decide whe
19、ther it will be confirmed for a further three years, revised to become an International Standard, or withdrawn. If the ISO/PAS or ISO/TS is confirmed, it is reviewed again after a further three years, at which time it must either be transformed into an International Standard or be withdrawn. Attenti
20、on 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/TS 19979 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophtha
21、lmic optics and instruments. DD ISO/TS 19979:2004 Licensed Copy: London South Bank University, London South Bank University, Sun Dec 10 13:26:19 GMT+00:00 2006, Uncontrolled Copy, (c) BSI iv Introduction Wherever possible, a trial contact lens should be used only on one individual. While the current
22、 trend in contact lens development is toward disposable and extended wear lenses, conventional lenses including RGP and soft contact lenses in special designs and parameters are necessary to meet individual patient needs. The subject of transmission of diseases such as nvCJD via multipatient use of
23、trial contact lenses has recently become a topic of discussion. It is anticipated that the discussions will be ongoing for some time making it impossible to reach agreement on an International Standard. Therefore, the working group decided that the publication of a Technical Specification for the hy
24、gienic management of multipatient use trial contact lenses would be appropriate at this time. However, this Technical Specification does not address the inactivation of prions since there are no reported cases of transmission of prions by contact lenses. The user of this Technical Specification shou
25、ld consult the scientific literature for any change in processes and procedures that may result. It is important that industry have available, a guideline in the form of a Technical Specification. If the standard is followed, the risk of patient-to-patient transmission of an infectious micro-organis
26、m from trial contact lenses may be reduced. This Technical Specification is not to be regarded as an International Standard. Its proposed application is provisional so that information and experience based on its use in practice may be gathered. DD ISO/TS 19979:2004 Licensed Copy: London South Bank
27、University, London South Bank University, Sun Dec 10 13:26:19 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 1 Ophthalmic optics Contact lenses Hygienic management of multipatient use trial contact lenses 1 Scope This Technical Specification provides guidance to contact lens manufacturers for the develo
28、pment of information to be provided to eye care practitioners for the hygienic management of trial soft and rigid gas- permeable (RGP) contact lenses intended for multipatient use. See Annex A for an example of labelling information. This Technical Specification does not address: national regulation
29、s for labelling of contact lenses; the inactivation of prions since there are no reported cases of transmission of prions by contact lenses. NOTE This Technical Specification acknowledges that risk factors for possible transmission of specific diseases by use of trial contact lenses on multiple pati
30、ents may vary by country or other political or geographical barriers. Legal requirements involving national practices or regulations take precedence over this Technical Specification. 2 Normative references The following referenced documents are indispensable for the application of this document. Fo
31、r dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO 14534:2002, Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements 3 Terms and definitions For the purpo
32、ses of this document the following terms and definitions apply. 3.1 trial contact lens diagnostic contact lens contact lens only used by a practitioner or fitter for the purpose of selecting the appropriate contact lens parameters for the intended wearer 3.2 multipatient use trial contact lens trial
33、 contact lens permitted to be used on more than one person DD ISO/TS 19979:2004 Licensed Copy: London South Bank University, London South Bank University, Sun Dec 10 13:26:19 GMT+00:00 2006, Uncontrolled Copy, (c) BSI 2 4 Methods of hygienic management for multipatient use of trial contact lenses 4.
34、1 General The contact lens manufacturers instructions for the hygienic management of multipatient use trial contact lenses should ensure that the performance criteria of methods of heat or chemical management are not compromised by the instructions. Manufacturers of contact lenses and contact lens c
35、are products should consider the issues that may arise when specifying a system for the hygienic management of multipatient use trial contact lenses (e.g., incompatibilities between a specific contact lens, lens care system, chemical agents and/or storage container). 4.2 Single use conditions All tr
36、ial contact lenses used with patients identified as potential carriers of infectious diseases such as CJD, herpes simplex, hepatitis, HIV or adenovirus shall be disposed of after use. Any lens known to be infected shall be discarded immediately to minimize contamination in practice. In this case, th
37、e use of disposable gloves is necessary. NOTE 1 If any countrys regulations require other infectious diseases to be added, these should apply in the country/area concerned. NOTE 2 Local regulations governing the disposal of biohazardous waste may apply. 4.3 Hand washing Instructions should be given
38、to wash the hands in accordance with the eye care professionals recommendations. NOTE For those countries without an eye care professions recommendation on hand washing, see A.1.2 and A.1.3. 4.4 Adjunctive solutions All solutions used in the hygienic management of contact lenses or contact lens cont
39、ainers shall meet the requirements of ISO 14534. Water from the tap should not be used to hygienically manage the contact lens or its container. 4.5 Use of a contact lens cleaner The use of a cleaning and rinsing solution(s) shall be part of the procedure of reprocessing of multipatient use trial co
40、ntact lenses, as specified by the manufacturer. All multipatient use trial contact lenses should be cleaned and rinsed just prior to use as well as after use. 4.6 Containers The contact lens manufacturer should state the type of container suitable for the hygienic management of multipatient use tria
41、l contact lenses. Consideration should be given to the recommendations of the manufacturer of the contact lens care system. The methods should be stated by which the container can be cleaned, properly closed and relabelled, if appropriate. 4.7 Frequency and lifetime of hygienic management of multipa
42、tient use trial contact lenses The physical performance criteria for discontinuation of use should be given by the contact lens manufacturer. Unless otherwise justified, the contact lens manufacturer should state the maximum number of times of re-use and the maximum duration of time from the first u
43、se as a multipatient use trial contact lens (e.g., not more than 25 trial uses and/or a 12-month duration for hydrogel trial lenses; for nonhydrogel trial lenses, the duration could be extended indefinitely). These times should not be exceeded. The manufacturer should encourage the practitioner to e
44、nsure that the multipatient use trial contact lens is examined to confirm that the lens is suitable for use (e.g., undamaged, free from deposits and within tolerance for dimensions). DD ISO/TS 19979:2004 Licensed Copy: London South Bank University, London South Bank University, Sun Dec 10 13:26:19 G
45、MT+00:00 2006, Uncontrolled Copy, (c) BSI 3 4.8 Options for hygienic management of multipatient use trial contact lenses 4.8.1 General The preference for trial contact lenses is to use the lens a single time, after which the lens is dispensed to the same individual or discarded in accordance with th
46、e procedures outlined in 4.2. If single use is not/cannot be followed, heat management is preferred over chemical management. Current scientific literature CDC, AAO, Smith and Pepose (see Bibliography) suggests the use of steam sterilization or a soak in 3 % hydrogen peroxide for sterilization or di
47、sinfection of trial lenses between patient fittings. Other chemical systems may be qualified as equivalent to 3 % hydrogen peroxide by a comparison of D-values obtained for a variety of challenge organisms including bacteria, fungi and viruses. 4.8.2 Heat management For lenses that are compatible wi
48、th heat, the preferred method is to sterilize the lenses, packed in appropriate solution and a sealed vial, such that the sterility assurance level will be less than or equal to 106 (e.g., 107, 108, etc.). For further information, consult the relevant standards in sterilization. In the absence of a
49、properly validated process, the lens cannot be described as sterile, only disinfected. 4.8.3 Chemical management Chemical management is achieved by soaking the lens. In the case of a 3 % hydrogen peroxide contact lens solution, the soaking period is for a minimum of three hours prior to neutralization of the hydrogen peroxide. Following neutralization of the hydrogen peroxide, the lens should be stored in a preserved solution. 4.8.4 Dry storage After completing the neutralizatio