ANSI Z80.7-2013 Ophthalmic Optics C Intraocular Lenses (VC)《眼内透镜》.pdf

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1、American National Standardfor Ophthalmic Optics Intraocular LensesANSI Z80.7-2013ANSI Z80.7-2013ANSIZ80.7-2013Revision ofANSI Z80.7-2002American National Standardfor Ophthalmic Optics Intraocular LensesSecretariatThe Vision CouncilApproved July 29, 2013 American National Standards Institute, Inc.App

2、roval of an American National Standard requires review by ANSI that therequirements for due process, consensus, and other criteria for approval havebeen met by the standards developer.Consensus is established when, in the judgement of the ANSI Board ofStandards Review, substantial agreement has been

3、 reached by directly andmaterially affected interests. Substantial agreement means much more thana simple majority, but not necessarily unanimity. Consensus requires that allviews and objections be considered, and that a concerted effort be madetowards their resolution.The use of American National S

4、tandards is completely voluntary; theirexistence does not in any respect preclude anyone, whether he has approvedthe standards or not, from manufacturing, marketing, purchasing, or usingproducts, processes, or procedures not conforming to the standards.The American National Standards Institute does

5、not develop standards andwill in no circumstances give an interpretation of any American NationalStandard. Moreover, no person shall have the right or authority to issue aninterpretation of an American National Standard in the name of the AmericanNational Standards Institute. Requests for interpreta

6、tions should beaddressed to the secretariat or sponsor whose name appears on the titlepage of this standard.CAUTION NOTICE: This American National Standard may be revised orwithdrawn at any time. The procedures of the American National StandardsInstitute require that action be taken periodically to

7、reaffirm, revise, orwithdraw this standard. Purchasers of American National Standards mayreceive current information on all standards by calling or writing the AmericanNational Standards Institute.American National StandardPublished byThe Vision Council225 Reinekers Lane, Suite 700Alexandria, VA 223

8、14Copyright 2013 by The Vision CouncilAll rights reserved.No part of this publication may be reproduced in anyform, in an electronic retrieval system or otherwise,without prior written permission of the publisher.Printed in the United States of AmericaDeveloped byThe Accredited Committee Z80 for Oph

9、thalmic Standards -The Vision CouncilZ80 Secretariat225 Reinekers Lane, Suite 700Alexandria, VA 22314iContentsPageForewordii1 Scope and Purpose12 Normative references.13 Vocabulary24 Physical requirements25 Optical requirements26 Mechanical requirements27 Biocompatibility requirements38 Sterility/pa

10、ckage integrity requirements.49 Shelf-life/shipping requirements5AnnexesA Genotoxicity test.6B Maximization sensitization test.7C Ocular Implantation Test8D Residual monomer determination - Methyl methacrylate.11E Bibliography13iiForeword(This foreword is not part of American National Standard ANSI

11、Z80.7-2013.)The Z80 Standards Committee for Ophthalmic Lenses was organized in 1956, andthe committees initial standard was issued in 1964. At the beginning of 1970, theZ80 Standards Committee was reorganized, with the Optical Society of Americaserving as secretariat. In 1972, the committee was auth

12、orized to broaden its scopefrom “prescription glass ophthalmic lenses“ to “prescription ophthalmic lenses.“ Sub-sequently, the scope of the committee was further broadened to “ophthalmic stan-dards.“The first Z80.7 subcommittee on intraocular lenses was established in 1976 to pro-vide intraocular le

13、ns standards that could be used by both manufacturers and physi-cians. Intraocular lenses are lenses that have optical and haptic components and thatare surgically implanted in the anterior or posterior chamber of the eye to correct vi-sion.In 1982, the Optical Laboratories Association (OLA) assumed

14、 the responsibility of theSecretariat; and in 1985, the Z80 committee became an accredited standards com-mittee. The scope of the Z80 committee is for the establishment of standards thatshall apply to ophthalmic lenses and to equipment, instruments and processes usedin the final fabrication level wh

15、ich affect their performance; to ophthalmic frames,sunglasses and fashion eyewear; to contact lenses and accessories for their use; tolow-vision aids and ophthalmic contact devices in addition to contact lenses; to opti-cal instrumentation used in ophthalmic procedures and vision evaluation; to intr

16、aocu-lar implant lenses; to viscoelastic devices; to aid ophthalmic endotamponades,ophthalmic irrigating solutions, glaucoma shunts, surgical microscopes used in oph-thalmic surgery and endoilluminators. Further additions were made concerning notonly intraocular implants used in cataract surgery, bu

17、t also in refractive surgery inphakic eyes, laser reshaping of the cornea and corneal implants to alter the refractivepower of the eye.The Z80.7 subcommittee deals with intraocular aphakic implants to correct the condi-tion of aphakia.The current ophthalmic standards are drafted by subcommittees of

18、the Z80 commit-tee. These subcommittees may, in turn, establish working groups, as needed, to ad-dress detailed areas in the assigned project.This standard contains five annexes. Annexes A through C are normative and areconsidered part of this standard. Annexes D and E are informative and are not co

19、n-sidered part of this standard.Suggestions for improvement of this standard will be welcome. They should be sentto The Vision Council, 225 Reinekers Lane, Suite 700, Alexandria, VA 22314.This standard was processed and approved for submission to ANSI by the Accredit-ed Standards Committee on Ophtha

20、lmics, Z80. Committee approval of this standarddoes not necessarily imply that all committee members voted for its approval. At thetime it approved this standard, the Z80 committee had the following members:Thomas C. White, ChairpersonQuido Cappelli, Vice-ChairpersonRobert Rosenberg, SecretaryJeffre

21、y Endres, SecretariatiiiOrganization Represented Name of RepresentativeAdvance Medical Technologies Association Paul LudingtonRichard Courtney (Alt.)Glenn Davies (Alt.)Bernie Liebler (Alt.)American Academy of OphthalmologyThomas C. White Carl Tubbs (Alt.)Pradeep Ramalu (Alt.)Shannon Curtis (Alt.)Ame

22、rican Acadamy of Optometry.David S. LoshinAmerican Ceramic SocietyLyle RubinHerbert Hoover (Alt.)American Glaucoma Society.Steven J. GeddeDouglas Rhee (Alt.)American Optometric Association Karl CitekRobert Rosenberg (Alt.)William Benjamin (Alt.)American Society of Cataract and Refractive SurgeryStep

23、hen KlyceJack T. Holladay (Alt.)Contact Lens Institute.Stan RogaskiPeter Mathers (Alt.)Contact Lens Manufacturers Association.Quido CappelliTroy Miller (Alt.)Department of Veterans Affairs.John TownsendMichael White (Alt.)Federated Cornea Societies.Michael BelinDavid Glasser (Alt.)Kathy Colby (Alt.)

24、Elmer Tu (Alt.)Food to quantify possible degradation products from hydrolysis; to quantify extractable additives and other leachables; to assure that toxic products that may result from processing, laser treatment, or aging do not affect the biocompatibility of the test material. 7.4.1 Testing of ex

25、tractable and hydrolytic stability Extractable and hydrolytic stability testing shall be performed in accordance with Annex A of ISO 11979-5 with the following additional requirement: 7.4.1.1 Optical stability testing The stability of the properties affecting the power and resolution of the IOL (e.g

26、., water uptake, refractive index) shall be demonstrated as part of the hydrolytic stability study. 7.4.2 Extractables by exhaustive extraction Exhaustive extraction by an appropriate solvent shall be performed to swell the polymer for determination of absolute levels of any free monomers, UV absorb

27、er or contaminants. An example of an exhaustive extraction method is described in Annex B of ISO/DIS 11979-6.2. An example of an exhaustive extraction method for PMMA is described in Annex D. 7.4.3 Photostability testing Testing for the photostability of the material shall be performed in accordance

28、 with Annex B of ISO 11979-5. 7.4.4 Nd:YAG laser exposure test Testing for the physical and chemical effects of Nd:YAG laser exposure on the IOL material shall be performed in accordance with Annex C of ISO 11979-5. 8 Sterility/package integrity requirements 8.1 Scope This section applies to the ste

29、rility and integrity of the packaging of the IOL in its final form, as intended for implantation in the human eye. The IOL shall be provided sterile. Whenever possible, the product shall be terminally sterilized in its final container. 8.2 Requirements 8.2.1 Validation of sterilization method The ma

30、nufacturer shall validate the sterilization method to be used for the IOL. Validation of steam sterilization shall be carried out in accordance with ISO 11134. Validation of ethylene oxide sterilization shall be carried out in accordance with ISO 11135. Validation of radiation sterilization shall be

31、 carried out in accordance with ISO 11137. 8.2.2 Sterility testing Device sterility testing shall be carried out in accordance with a validated sterility test that includes a Growth Promotion test and ANSI Z80.7-2013 5 bacteriostatis/fungistatis testing (U.S. Pharmacopeia 24, , 2000 contains additio

32、nal information). Sterility testing performed on biological indicators (BIs) shall be carried out in accordance with a validated sterility test that includes a Growth Promotion test (U.S. Pharmacopeia 24 , 2000 contains additional information). 8.2.3 Bacterial endotoxins Bacterial endotoxin testing

33、shall be conducted in accordance with a validated bacterial endotoxin test that includes an inhibition/enhancement test (U.S. Pharmacopeia 36, , 2012 and ANSI/AAMI ST 72 contain additional information on test methods). U.S. Pharmacopeia 36, 2012, , contains information on appropriate endotoxin level

34、s. NOTE - For new IOL submissions, guidance on endotoxin limits should be obtained from the FDA Center for Devices and Radiological Health. 8.3 Package integrity testing Package integrity testing shall consist of a seal integrity test and either a microbial barrier test or a whole package physical i

35、ntegrity test. ASTM F1585-95, ASTM F1929-98, ISO 2248, ISO 8318, and ISO 11607 contain information regarding package integrity testing. 8.4 Ethylene oxide residual testing For those implants sterilized by ethylene oxide, residual testing shall be carried out in accordance with ISO 10993-7 (1995) and

36、 the AAMI TIR No. 19 for ISO 10993-7 with the following additional requirements: 8.4.1 Ethylene oxide extraction The ethylene oxide analysis procedure shall utilize a solvent extraction or a head space exhaustive extraction. NOTE - Manufacturers should choose a solvent that adequately swells or diss

37、olves the lens material to facilitate extraction of the ethylene oxide molecules. A headspace method may be used if it has been validated to demonstrate that the extraction is as exhaustive as a solvent method. Alternatively, the manufacturer may demonstrate the relative efficiency of an extraction

38、method and adjust the internal release specifications accordingly. 8.4.2 Ethylene chlorohydrin residue levels The ethylene chlorohydrin residue in IOLs shall not exceed 2.0 g ECH per implant per day, not to exceed 5.0 g per implant. NOTE - Ethylene glycol residues should be sufficiently controlled b

39、y the limits set for ethylene oxide and ethylene chlorohydrin residues. 9 Shelf-life/shipping requirements 9.1 Scope This section applies to the ability of the packaging to protect the IOL from damage during shipping and to maintain the sterility of the device for the duration of its shelf-life. 9.2

40、 Requirements The manufacturer shall perform the testing described in ISO/DIS 11979-6.2. 10 Clinical evaluation This section applies to the clinical performance of the IOL in its final form, as intended for implantation in the human eye for aphakia following cataract extraction. 10.1 Requirements Th

41、e general requirements concerning the clinical investigations of medical devices for human subjects specified in ISO 14155:1996 shall apply. More specific requirements for monofocal IOLs are included in ISO 11979-7, and shall also apply. ANSI Z80.7-2013 6 Annex A (normative) Genotoxicity test A.1 Pu

42、rpose The purpose of this test is to determine if the material has any genotoxic potential. A.2 General Testing of the genotoxic potential of materials to be used in IOLs is essential unless materials already proven to be nongenotoxic are used, or if extracted compounds can be identified by suitable

43、 analytical methods and these compounds are known to possess no genotoxicity. A.3 Test material Sterile finished IOLs or facsimile material that has been cut into pieces to give about the same mass-to-surface-area ratio as what would be obtained with finished IOLs shall be used. If the manufacturers

44、 instruction for surgical use specified any forms of treatment prior to implantation, the test material is treated accordingly. Otherwise, no treatment, e.g., rinsing, is given. A.4 Test procedure The test material is extracted with two different extractants, one of which is physiological saline, an

45、d the second a lipophilic or dipolar solvent. Choose a lipophilic or dipolar solvent that does not dissolve or degrade the test material. Extraction is to be performed at 37C 2C for 72 2 hours at a ratio of one gram of material per 10 ml of extracting medium. The extracts are tested for genotoxicity

46、 in accordance with ISO 10993-3. A.5 Test evaluation The test results shall be interpreted in accordance with ISO 10993-3. ANSI Z80.7-2013 7 Annex B (normative) Maximization sensitization test B.1 Purpose The purpose of this test is to assess the potential of the test material to produce sensitizati

47、on. B.2 General ISO 10993-10 gives general guidance on maximization sensitization testing. This annex defines the specific test conditions for testing IOLs. ISO 10993-10 gives the necessary guidelines on how to carry out the actual testing. B.3 Test material Sterile finished IOLs or facsimile materi

48、al that has been cut into pieces to give about the same mass-to-surface-area ratio as what would be obtained with finished IOLs shall be used. If the manufacturers instruction for surgical use specifies any form of treatment prior to implantation, the test material is treated accordingly. Otherwise,

49、 no treatment, e.g., rinsing, is given. B.4 Equipment The equipment is described in ISO 10993-10. B.5 Test procedure The test material is extracted with two different extractants, one of which is physiological saline, and the second a lipophilic or dipolar solvent. Choose a lipophilic or dipolar solvent that does not dissolve or degrade the test material. Prepare the extracts in accordance with Annex B of ISO 10993-10. Subject the extracts to testing in accordance with ISO 10993-10. Omit the preliminary tests described in clause 6.3.4.2 of ISO 10993-10 and carry out the proc