ANSI Z80.13-2007 Ophthalmics C Phakic Intraocular Lenses (VC)《晶体眼人工晶体植入术》.pdf

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1、American National Standardfor Ophthalmics Phakic Intraocular LensesANSI Z80.13-2007 (R2012)ANSI Z80.13-2007(R2012)ANSIZ80.13-2007 (R2012)Reaffirmation ofANSI Z80.13-2007American National Standardfor Ophthalmics Phakic Intraocular LensesSecretariatThe Vision CouncilApproved March 26, 2007Reaffirmed A

2、pril 16, 2012American National Standards 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 AN

3、SI Board ofStandards Review, substantial 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

4、madetowards their resolution.The use of 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 th

5、e standards.The American National Standards 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 Am

6、ericanNational Standards Institute. Requests 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 Stand

7、ardsInstitute require that action be taken 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 Vi

8、sion Council225 Reinekers Lane, Suite 700Alexandria, VA 22314Copyright 2012 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

9、 of AmericaDeveloped byThe Accredited Committee Z80 for Ophthalmic Standards -The Vision CouncilZ80 Secretariat225 Reinekers Lane, Suite 700Alexandria, VA 22314iContentsPageForeword .iv1 Scope and purpose 12 Normative references. 13 Definitions 24 Physical requirements 24.1 Scope. 24.2 Requirements.

10、 24.2.1 Tolerances and dimensions. 25 Optical requirements 25.1 Scope. 25.2 Requirements. 25.2.1 Dioptric power 25.2.2 Imaging quality. 25.2.3 Spectral transmittance . 26 Mechanical requirements. 36.1 Scope. 36.2 Requirements. 36.2.1 Mechanical characterization 36.2.2 Mechanical testing . 36.2.2.1 S

11、urgical manipulation evaluation . 36.2.2.2 Surface and bulk homogeneity 37 Biocompatibility requirements 37.1 Scope. 37.2 General guidelines. 37.3 Biological test requirements. 47.4 Physicochemical test requirements . 48 Sterility/package integrity requirements. 48.1 Scope. 48.2 Requirements. 49 She

12、lf-life and transport stability 59.1 Scope. 59.2 Requirements. 510 Clinical investigation plan. 510.1 Scope. 510.2 Clinical investigation plan. 511 Labeling . 6iiPageAnnexesA Mechanical characterization and testing of phakic IOLs 8A.1 General 8A.2 Mechanical characterization 8A.2.1 Anatomical placem

13、ent analysis . 8A.2.2 Clear optic diameter. 8A.2.3 Compression force. 8A.2.4 Compression force decay 8A.2.5 Axial displacement in compression 9A.2.6 Angle of contact . 9B Non-ocular implantation test 10C Ocular implantation test . 11C.1 Purpose . 11C.2 Test material 11C.3 Control material . 11C.4 Ap

14、pratus and supplies . 11C.5 Test procedure. 11C.6 Intraoperative observations . 12C.7 Implantation period 12C.8 Test evaluations. 13C.8.1 Postoperative evaluations 13C.8.2 Evaluation of enucleated eyes. 13C.8.3 Evaluation of explanted lenses 13D Clinical guidance 15D.1 General 15D.2 Objectives 15D.3

15、 Design 15D.3.1 Investigation duration. 15D.3.2 Enrollment of subjects . 15D.3.3 Inclusion and exclusion criteria for subject selection . 16D.3.3.1 Inclusion criteria. 16D.3.3.2 Exclusion criteria 17D.3.4 Examination schedules 18iiiPageD.4 Clinical tests . 18D.4.1 Visual acuity . 21D.4.1.1 Luminance

16、 22D.4.1.2 Data recording procedures. 22D.4.2 Specular microscopy 22D.4.3 Contrast sensitivity . 24D.4.4 Crystalline lens status 25D.4.5 Mesopic pupil size 25D.4.6 Slit lamp exam 26D.4.7 Measurement of introcular pressure 26D.4.8 Anatomical placement substudy 26D.4.9 Subject questionnaire. 26D.5 Inv

17、erstigation analyses. 27D.5.1 Safety analyses 27D.5.2 Effectiveness analyses. 28D.5.3 Accountability analysis . 28D.6 Adverse events and adverse device effects. 30E Statistical sample size considerations 31E.1 General 31E.2 Sample size guidance 31E2.1 Safety and performance evaluation . 32E.2.2 Cont

18、rast sensitivity substudy 33F Bibliography . 35TablesD.1 Recommended minimum endothelial cell density 17D.2 Recommended postoperative examination schedule 19D.3 Accountability at each postoperative visit 29E.1 Confidence interval parameter definitions 32E.2 Normal distribution statistics and paramet

19、ers 32E.3 Normal quantities to use in equations 32ivForeword (This foreword is not part of American National Standard ANSI Z80.13-2007 (R2012).)ANSI Z80.13-2007, Ophthalmics - Phakic intraocular lenses, was developed by agroup of experts consisting of scientists, industrialists, government regulator

20、s and cli-nicians among them developers and/or manufacturers of such lasers. This standardapplies to the physical and mechanical properties and performances as well as mate-rial biocompatibility and describes elements of clinical protocol to be used to assessthe clinical performance of these devices

21、 with the crystaline lens in place to correctrefractive errors. The standard also contains informative sections. Suggestions for improvements of the standard are welcome. These should be sent toThe Vision Council, 225 Reinkers Lane, Suite 700, Alexandria, VA 22314.AMERICAN NATIONAL STANDARD ANSI Z80

22、.13-2007 (R2012)American National Standard for Ophthalmics Phakic Intraocular Lenses 1 1 Scope and purpose This standard applies to any intraocular lens (IOL) whose primary indication is the modification of the refractive power of a phakic eye. It does not include IOLs used to correct presbyopia or

23、astigmatism. This standard addresses the vocabulary, optical properties and test methods, mechanical properties and test methods, labeling, biocompatibility, sterility, shelf-life and transport stability, and clinical investigations necessary for this type of device. As applies to any standard, alte

24、rnative validated test methods may be used. 2 Normative references The following standards contain provisions that, through reference in this text, constitute provisions of this American National Standard. All standards are subject to revision, and parties to agreements based on this American Nation

25、al Standard are encouraged to investigate the possibility of applying the most recent editions of the standards indicated below. Members of the IEC and ISO maintain registers of currently valid International Standards. ANSI Z80.7-2002, Ophthalmics Intraocular lenses Good Laboratory Practices (GLP),

26、U.S. Code of Federal Regulations, 21, Part 58 ISO 10993-2:1998, Biological evaluation of medical devices Part 2: Animal welfare requirements ISO 11979-1:1999, Ophthalmic implants Intraocular lenses Part 1: Vocabulary ISO 11979-2:1999, Ophthalmic implants Intraocular lenses Part 2: Optical properties

27、 and test methods ISO 11979-3:1999, Ophthalmic implants Intraocular lenses Part 3: Mechanical properties and test methods ISO 11979-5:1999, Ophthalmic implants Intraocular lenses Part 5: Biocompatibility ISO 11979-6:2002, Ophthalmic implants Intraocular lenses Part 6: Shelf-life and transport stabil

28、ity ISO 14155-1:2003, Clinical investigation of medical devices - Part 1: General Requirements ISO 14155-2:2003, Clinical investigation of medical devices - Part 2: Clinical investigation plans ANSI Z80.13-2007 (R2012) 2 3 Definitions For the purpose of this standard, in addition to the definitions

29、in ISO 11979-1, the following definition applies. 3.1 Phakic IOL: intraocular lens whose primary indication is the modification of the refractive power of a phakic eye 4 Physical requirements 4.1 Scope This clause applies to the physical properties of the phakic IOL in its final form, as intended fo

30、r implantation in the human eye. 4.2 Requirements 4.2.1 Tolerances and dimensions The requirements given in 4.1 and 4.2 of ISO 11979-3 apply. 5 Optical requirements 5.1 Scope This clause applies to the optical properties and performance requirements of the phakic IOL in its final form, as intended f

31、or implantation in the human eye. 5.2 Requirements 5.2.1 Dioptric power The requirements given in 4.2 of ISO 11979-2 shall apply. 5.2.2 Imaging quality The requirements given in 4.3 of ISO 11979-2 shall apply. NOTE: A modified bench (e.g., additional converging lens, a microscope objective of approp

32、riate numerical aperture, etc.) may be needed to quantify the image quality of negative power phakic IOLs. The manufacturer shall demonstrate that the entire range of available powers of a phakic IOL meets this specification. 5.2.3 Spectral Transmittance The requirements in 4.4 of ISO 11979-2 shall

33、apply with the following additional requirements. The spectral transmittance in the range of 300 nm to 1100 nm shall be recorded through a flat piece of the phakic IOL optic material that is 1mm thick. ANSI Z80.13-2007 (R2012) 3 NOTE: Additional information may be found in ISO 8599 1 and ISO 11979-2

34、. 6 Mechanical requirements 6.1 Scope This clause applies to the mechanical properties and performance requirements of phakic IOLs in the assembled or final form, as intended for implantation in the human eye. 6.2 Requirements 6.2.1 Mechanical characterization Manufacturers shall report the results

35、of the tests described in Annex A, as appropriate. 6.2.2 Mechanical testing The requirements in 4.1, 4.5, 4.6, 4.9, and 4.10 of ISO 11979-3 shall apply, with the following additional testing requirements. 6.2.2.1 Surgical manipulation evaluation The manufacturer shall develop a test method and speci

36、fication to indicate the ability of the device to withstand surgical manipulation during implantation. An appropriate specification shall be established to ensure that the device does not fail at typical deformations. 6.2.2.2 Surface and bulk homogeneity The phakic IOL shall be essentially free from

37、 defects. NOTE: “Defects” means deviations from surface and bulk homogeneity that are not intended features of the design, including all kinds of surface defects such as scratches, digs, protrusions, cracks, roughness, etc. as well as bulk defects such as inclusions, bubbles, striae, discoloration,

38、etc. The phakic IOL should be inspected at 10x under optimal lighting conditions; any questionable areas should be viewed at higher magnification. 7 Biocompatibility requirements 7.1 Scope This clause applies to the biocompatibility requirements for the phakic IOL in the assembled or final form, as

39、intended for implantation in the human eye. 7.2 General guidelines 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. If animal testing is indicated, it shall be carried out in accordance with

40、ISO 10993-2. Unless otherwise indicated, the materials used in biological testing can either be the sterile finished phakic IOLs or facsimile materials fabricated and processed in a manner equivalent to that used for the ANSI Z80.13-2007 (R2012) 4 phakic IOLs. The manufacturer shall establish and do

41、cument equivalency in material and in test sensitivity, where appropriate, for the test sample and the sterile finished phakic IOL. 7.3 Biological test requirements The requirements in 7.3, except for 7.3.5, of ANSI Z80.7 shall apply with the following additional requirements. Manufacturers of new I

42、OL materials shall include in their risk analysis an assessment of the potential for material changes such as calcification. The risk analysis should consider the history of clinical use of the material, and tests to assess the long-term stability of the material in an animal model. One non-ocular i

43、mplantation test to assess the stability of the material is described in Annex B. The ocular implant test described in Annex C of this standard shall be performed. 7.4 Physicochemical test requirements The requirements in clause 5 of ISO 11979-5 shall apply with the following additional requirements

44、. The dioptric power shall be determined before and after testing if finished phakic IOLs are used in hydrolysis testing. The refractive index shall be determined instead if a facsimile material is used. There shall be no significant change in diopter power or refractive index after hydrolysis testi

45、ng that result in the dioptic power or refractive index being out of specification. The phakic IOL material shall be evaluated for the presence of residual insoluble inorganics in or on the phakic IOL arising from the manufacturing materials and process aids. Where possible residues have been identi

46、fied, the phakic IOL shall be evaluated for such residuals. The test method used for this evaluation should be identified, validated and justified. Consideration shall be given to methods that use solvents that dissolve the contaminating materials and that have a detection limit of 0.2 g/lens or 10

47、g/g. Correlation between these results and the results from any biological tests, if any, should be documented. 8 Sterility/package integrity requirements 8.1 Scope This clause applies to the sterility and integrity of the packaging of the phakic IOL in its final form, as intended for implantation i

48、n the human eye. The phakic IOL shall be provided sterile. Whenever possible, the product shall be terminally sterilized in its final container. 8.2 Requirements The requirements as listed in 8.2 of ANSI Z80.7 shall apply. ANSI Z80.13-2007 (R2012) 5 9 Shelf-life and transport stability 9.1 Scope Thi

49、s clause applies to the ability of the packaging to protect the phakic IOL from damage during transport and to maintain the sterility of the device for the duration of its shelf-life. 9.2 Requirements The requirements in ISO 11979-6 shall apply. 10 Clinical investigation plan 10.1 Scope This clause applies to the clinical performance of the phakic IOL in its final form, as intended for implantation in the human eye. 10.2 Clinical investigation plan The requirements in ISO 14155-1 and ISO 14155-2 shall apply with the following additional requirements. To min