ANSI Z80.27-2014 Ophthalmics C Implantable Glaucoma Devices (VC)《青光眼治疗用眼液分流器》.pdf

1、American National Standardfor Ophthalmics Implantable Glaucoma DevicesANSI Z80.27-2014ANSIZ80.27-2014ANSIZ80.27-2014(revision ofANSI Z80.27-2001(R2011)American National Standardfor Ophthalmics Implantable Glaucoma DevicesSecretariatThe Vision CouncilApproved January 27, 2014American National Standar

2、ds Institute, Inc.Approval 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, substanti

3、al agreement has been 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 o

4、f American National Standards 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 Stan

5、dards Institute does 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. Re

6、quests for interpretations 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 t

7、aken periodically to 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 CouncilZ80 Secretariat225 Reineke

8、rs LaneAlexandria, VA 22314Copyright 2014 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 Accredi

9、ted Committee Z80 for Ophthalmic StandardsThe Vision CouncilZ80 Secretariat225 Reinekers LaneAlexandria, VA 22314iContentsPageForeword ii1 Scope and purpose 12 Normative references. 13 Definitions 24 Design attributes and evaluation 24.1 Scope. 24.2 General guidelines. 35 Physical and mechanical req

10、uirements . 35.1 Scope. 35.2 Surface quality . 35.3 Edge quality . 35.4 Dimensions 35.5 Physical stability. 35.6 Pressure/flow characteristics . 45.7 Structural integrity 46 Biocompatiblity requirements. 46.1 Scope. 46.2 General guidelines. 46.3 Biological requirements 46.3.1 Texts on extracts 56.3.

11、2 Cytotoxicity. 56.3.3 Genotoxicity . 56.3.4 Sensitization test 56.3.5 Immunotoxicity testing . 56.3.6 Ocular implantation test . 66.3.7 Rabbit pyrogen test 66.4 Physicochemical test requirements . 66.4.1 Extractables by exhaustive extraction 66.4.2 Test for leachables. 66.4.3 Hydrolysis testing. 67

12、 Sterility/package integrity requirements. 77.1 Scope. 77.2 General guidelines. 77.3 Requirements. 77.4 Ethylene oxide sterilent residues . 77.5 Bacterial endotoxin 78 Shelf-life and transport stability requirements 78.1 Scope. 78.2 Requirements. 8iiPage9 Additional requirements . 89.1 Insertion met

13、hod 89.2 Surface coatings 810 Clinical evaluation 810.1 Scope. 810.2 Clinical investigational plan 811 Labeling . 9AnnexesA Examples of practices for in-Vitro flow characteristics ofaqueous shunt type of implantable glaucoma devices 10B Ocular implantation test . 14C Guidance on clinical study desig

14、n for implantable glaucomadevices with refractory glaucoma indications 17D Guidance on clinical study design for implantable glaucomadevices with nonrefractory glaucoma indications 21E Evaluations, methodology and adverse events . 27F Statistical sample size considerations for nonrefractory glaucoma

15、devices. 33G Recommended analysis of data from the clinical investigation . 35H Labeling for implantable glaucoma devices. 38I Bibliography . 40TablesC.1 Recommended examination schedule - Refractory glaucomaindication devices 20D.1 Recommended minimum endothelial cell density 24D.2 Recommended exam

16、ination schedule - nonrefractory glaucomaindication devices 26F.1 Symbol definitions 33G.1 Accountability at each visit enrolled (N) = _. 35iiiForeword (This foreword is not part of American National Standard ANSI Z80.27-2014.)ANSI Z80.27-2014 was developed by a group of experts under the direct cha

17、irman-ship of Dr. Carl Tubbs, with detailed editing by the group secretary, Jane Ellen Giamporcaro. The current standard represents a revision of the original and first2001 document chaired by Dr. Dale Heuer, and pertains to the physical, biocompati-bility, and mechanical properties, as well as to p

18、erformance properties of implantablemedical devices that are designed to lower IOP (intraocular pressure). The revisionwas completed by an active group of basic scientists, industrialists, regulatory agen-cies, clinicians, and clinician researchers, and involved spirited discussion on severalfronts.

19、 Z80.27 is a subcommittee on Medical Ophthalmic Devices of ANSI (Accredit-ed Standards Committee) Z80.Z80 Committee was established in 1956, and is now a U.S. standards developer andaccredited by ANSI. The Vision Council became Secretariat for Z80 in January of2009. The Z80 committee, made up of 19

20、voting organizations and more than 200participants, meets at least twice a year in order to regularly create and to rewritedraft standards. There are eight subcommittees that operate under the Z80 parentcommittee. The Medical Ophthalmic Devices (SC4) subcommittee deals with intraoc-ular lenses (whet

21、her phakic or aphakic, toric or accommodative); devices to changethe refractive power of the eye including lasers; viscoelastic devices; ophthalmic irri-gating solutions; and finally, implantable glaucoma devices. The Z80.27 standard contains nine annexes, A through I. The annexes are informa-tive a

22、nd supply additional guidance, but are not considered part of the standard.Suggestions for improvement of this standard are welcome. They should be sent tothe Vision Council, 225 Reinekers Lane, Suite 700, Alexandria, VA 22314.This standard was processed and approved for submittal to ANSI by the Acc

23、reditedStandards Committee on Ophthalmic Optics, Z80. Committee approval of this stan-dard indicates general consensus but in no way implies that all committee membersvoted for approval. At the time it approved this standard, the Z80 Committee had thefollowing members:Thomas C. White, M.D., Chairman

24、Quido Cappelli, Vice-Chairman Dr. Robert Rosenberg, O.D., SecretaryJeff Endres, Secretariat Z80Organization Represented Name of RepresentativeAdvance Medical Technologies Michael PflegerRichard Courtney (Alt.)American Academy of Ophthalmology . Thomas WhiteCarl Tubbs (Alt.)Pradeep Ramulu (Alt.)Shann

25、on Curtis (Alt.)American Academy of Optometry. David LoshinAmerican Ceramic Society . Lyle RubinHerbert Hoover (Alt.)American Glaucoma Society Steven GeddeDouglas Rhee (Alt.)American Optometric Association Karl CitekRobert Rosenberg (Alt.)William Benjamin (Alt.)American Society of Cataract and Refra

26、ctive Surgery (ASCRS) . Steven KlyceJack Holladay (Alt.)Contact Lens Institute. Stan RogaskiPeter Mathers (Alt.)ivOrganization Represented Name of RepresentativeContact Lens Manufacturers Association. Quido CappelliTroy Miller (Alt.)Department of Veterans Affairs John TownsendMichael White (Alt.)Fed

27、erated Cornea Societies. Michael BelinDavid Glasser (Alt.)Kathy Colby (Alt.)Elmer Tu (Alt.)Food there shall be no observable unintended leaks. Annex A describes examples of test methods for determining the theoretical flow characteristics of these devices. 5.7 Structural integrity The junctions of a

28、ny components of the implantable glaucoma devices shall be able to withstand an axial-pull force of 0.5 N without breaking or resulting in the loss of the leak-free junction. Manufacturers are encouraged to confirm that the 0.5 N axial load aligns with the force loading seen during implantation. If

29、the force loading is not applicable, the manufacturer can elect to specify a different requirement, based on actual stresses encountered, during the implantation procedure, using an animal model or other bench model. Methodology such as a modification of method described in annex H of ISO 11979-3 ma

30、y be employed. NOTE: The adequacy of the structural integrity specification should be validated by an assessment of the devices structural failure rate in the clinical study 6 Biocompatibility requirements 6.1 Scope This clause applies to the biocompatibility requirements for implantable glaucoma de

31、vices in the assembled or final form as intended for implantation in the human eye. These requirements include evaluation of physicochemical properties that are relevant to biocompatibility. 6.2 General guidelines Unless otherwise indicated, the materials used in biocompatibility testing should eith

32、er be sterile finished implantable glaucoma devices or facsimile materials fabricated and processed in a manner equivalent to that used for the devices. The manufacturer shall establish and document equivalency in material and in test sensitivity, where appropriate, for the test sample and the steri

33、le finished glaucoma device. All biological tests shall be performed in accordance with the requirements of Good Laboratory Practices (GLP), U.S. Code of Federal Regulations 21, Part 58. The treatment of animals during testing, where indicated, shall be carried out in accordance with ISO 10993-2. So

34、me of the requirements may be waived if there is documented evidence that the glaucoma device material is identical to that used in another implantable device of an identical or equivalent application and which has been widely marketed for at least the last five years. ANSI Z80.27-2014 5 6.3 Biologi

35、cal requirements The general requirements specified in ISO 10993-1 shall apply, together with the following particular requirements: 6.3.1 Tests on extracts In tests that are conducted on material extracts, testing shall be conducted with two different extractants, one of which is an aqueous solutio

36、n, e.g., physiological saline (the formulation shall be reported), and the other a lipophilic or dipolar solvent. Extraction for cytotoxicity testing should be performed according to ISO 10993-5. The extractant(s) used shall be appropriate for the cytotoxicity test method(s). 6.3.2 Cytotoxicity Cyto

37、toxicity testing of the glaucoma device shall be carried out in accordance with the requirements of ISO 10993-5. The following cytotoxicity tests are examples that would satisfy the ISO requirements: 6.3.2.1 Direct contact solid Direct contact assessments (the qualitative assessment of damage to cel

38、ls that are at a stationary phase when in direct contact with the material) shall demonstrate a noncytotoxic response. NOTE: The agar diffusion test can be used if the design and/or density of the device do not lend themselves to the direct contact test. 6.3.2.2 Medium elution (qualitative assessmen

39、t of damage to cells that are at a stationary phase when exposed to an extract of the test material prepared in a physiological solution). The results shall demonstrate a noncytotoxic response. 6.3.2.3 Percent cell growth inhibition. One point (quantitative assessment of the effect of a material ext

40、ract on cells at the growth phase). The result shall demonstrate a lack of potential for inhibition of cell growth. NOTE: Alternate cytotoxicity tests can be used, provided that they have the same endpoints and the methods have been validated. 6.3.3 Genotoxicity Genotoxicity testing shall be conduct

41、ed in accordance with ISO 10993-3. The results shall demonstrate a lack of genotoxicity. NOTE: Carcinogenicity testing can be considered to demonstrate biocompatibility if genotoxicity testing has demonstrated a genotoxic potential in the test material. 6.3.4 Sensitization test Sensitization testing

42、 shall be conducted in accordance with ISO 10993-10. The results shall demonstrate a lack of sensitization potential. NOTE: The maximization sensitization test is the preferred test method. The local lymph node assay can also be used except for testing of implantable glaucoma devices containing meta

43、ls or metallic salts. ANSI Z80.27-2014 6 6.3.5 Immunotoxicity testing Immunotoxicity testing shall be considered for glaucoma devices fabricated from or containing materials derived from animal or plant sources. Where indicated, the results shall demonstrate a lack of immunotoxicity. NOTE: The use o

44、f Guidance for Industry and FDA Reviewers Immunotoxicity Testing Guidance, May 6, 1999, as a reference, is recommended. 6.3.6 Ocular implantation test This test shall be performed on the glaucoma device in lieu of the chronic toxicity test specified in ISO 10993-1. Annex B provides guidance to demon

45、strate the tolerance of the test material after implantation into the eye of an appropriate animal model. The results shall demonstrate that the test material is well tolerated by the ocular tissue. Unless the glaucoma device is intended to be biodegradable, the material shall also be stable over th

46、e implantation period. 6.3.7 Rabbit pyrogen test The rabbit pyrogen test shall be performed on the glaucoma device in accordance with the guidance in USP 31 NF 26 if the device is fabricated from a new material or if the device is coated to evaluate the presence of any material-mediated pyrogen. The

47、 material shall be nonpyrogenic. 6.4 Physiochemical test requirements Physicochemical testing shall be performed on the glaucoma device in order to assure that any toxic products that may result from processing, aging, and degradation do not affect the biocompatibility of the test material. Such tes

48、ting shall quantify potential residues from synthesis and impurities from manufacturing, possible degradation products from hydrolysis, extractable additives, and other leachables. 6.4.1 Extractables by exhaustive extraction The levels of monomers, additives, and other contaminants in the glaucoma d

49、evice that can be extracted under exhaustive extraction conditions shall be determined. A test method that can be adopted for use can be found in Annex A of ISO 11979-5. A risk analysis shall be performed to justify the levels of extractables detected, if any. 6.4.2 Test for leachables The levels of monomers, additives, and other contaminants in the glaucoma device that can be extracted under physiological conditions shall be determined. A test method that can be adopted for use can be found in Annex B of ISO 11979-5. A risk analysis shall be performed to justify the levels o