ANSI-Z80.18-2003.pdf
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1、AMERICAN NATIONAL STANDARDAMERICAN NATIONAL STANDARD OLA ANSI Z80.18-2003 for Ophthalmics Contact Lens Care Products Vocabulary, Performance Specifications and Test Methodology Copyright American National Standards Institute Provided by IHS under license with ANSI Licensee=USN Ship Repair Facility Y
2、okosuka/9961031100 Not for Resale, 05/08/2007 23:35:56 MDTNo reproduction or networking permitted without license from IHS -,-,- Copyright American National Standards Institute Provided by IHS under license with ANSI Licensee=USN Ship Repair Facility Yokosuka/9961031100 Not for Resale, 05/08/2007 23
3、:35:56 MDTNo reproduction or networking permitted without license from IHS -,-,- ANSI Z80.18-2003 American National Standard for Ophthalmics Contact Lens Care Products Vocabulary, Performance Specifications and Test Methodology Secretariat Optical Laboratories Association Approved May 1, 2003 Americ
4、an National Standards Institute, Inc. Copyright American National Standards Institute Provided by IHS under license with ANSI Licensee=USN Ship Repair Facility Yokosuka/9961031100 Not for Resale, 05/08/2007 23:35:56 MDTNo reproduction or networking permitted without license from IHS -,-,- Approval o
5、f an American National Standard requires review by ANSI that the requirements for due process, consensus, and other criteria for approval have been met by the standards developer. Consensus is established when, in the judgement of the ANSI Board of Standards Review, substantial agreement has been re
6、ached by directly and materially affected interests. Substantial agreement means much more than a simple majority, but not necessarily unanimity. Consensus requires that all views and objections be considered, and that a concerted effort be made towards their resolution. The use of American National
7、 Standards is completely voluntary; their existence does not in any respect preclude anyone, whether he has approved the standards or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the standards. The American National Standards Institute
8、 does not develop standards and will in no circumstances give an interpretation of any American National Standard. Moreover, no person shall have the right or authority to issue an interpretation of an American National Standard in the name of the American National Standards Institute. Requests for
9、interpretations should be addressed to the secretariat or sponsor whose name appears on the title page of this standard. CAUTION NOTICE: This American National Standard may be revised or withdrawn at any time. The procedures of the American National Standards Institute require that action be taken p
10、eriodically to reaffirm, revise, or withdraw this standard. Purchasers of American National Standards may receive current information on all standards by calling or writing the American National Standards Institute. American National Standard Published by Optical Laboratories Association P. O. Box 2
11、000 Merrifield, VA 22116-2000 Copyright 2003 by Optical Laboratories Association All rights reserved. No part of this publication may be reproduced in any form, in an electronic retrieval system or otherwise, without prior written permission of the publisher. Printed in the United States of America
12、Developed by The Accredited Committee Z80 for Ophthalmic Standards - Optical Laboratories Association Z80 Secretariat P. O. Box 2000 Merrifield, VA 22116-2000 Copyright American National Standards Institute Provided by IHS under license with ANSI Licensee=USN Ship Repair Facility Yokosuka/9961031100
13、 Not for Resale, 05/08/2007 23:35:56 MDTNo reproduction or networking permitted without license from IHS -,-,- i Contents Page Forewordii 1Scope 1 2Normative References 1 3Vocabulary 3 3.1General Terms Relating to Contact Lens Care Products - ISO 8320-2 3 3.2Specific Terms Relating to Contact Lens C
14、are Products - ISO 8320-2 4 4General Specifications of Contact Lens Care Products 7 5Standard Test Methods. 8 5.1Physicochemical Methods. 8 5.1.1Preservative Uptake and Release - ISO 11986 8 5.1.2Determination of Shelf-life - ISO 13212. 8 5.1.3Lens Compatibility - ISO 11981 8 5.1.4Cleaning Effective
15、ness - FDA Guidance. 9 5.2Toxicology. 9 5.2.1In vitro Cytotoxicity - ISO 10993-5. 9 5.2.2Acute Ocular Irritation - ISO 9394 or USP/NF XXII. 10 5.2.3Acute Oral Toxicity - FDA Guidance . 10 5.2.4Sensitization (Guinea Pig Maximization) - FDA Guidance 10 5.2.5In vivo Ocular Biocompatibility - ISO 9394 1
16、1 5.2.6Toxicology Tests for Containers and Plastic Accessories - USP24 11 5.3Microbiology 11 5.3.1Sterility - FDA Guidance 11 5.3.2Validation of Sterilization of Solutions and Containers 12 5.3.3Microbial Limits Non-sterile Solids - ISO 14534 to oph- thalmic frames, sunglasses, and fashion eyewear;
17、to contact lenses and their acces- sories for use; to intraocular implant lenses; to low vision aids and ophthalmic procedures and vision evaluation. In 1982, the Optical Laboratories Association (OLA) assumed the responsibilities of the Secretariat, and, in 1985, the Z80 Committee became an Accredi
18、ted Standards Committee. Currently, ophthalmic standards are drafted by subcommittees of the Z80 committee, which in turn may establish working groups to address specific de- tailed areas of interest. In the past decade, the Subcommittee for Contact Lenses has provided delegates to the International
19、 Standards Organization to represent the American National Stan- dards Institutes role in developing and approving contact lens care products stan- dards for the international community. During the many sessions to accomplish this task, it became apparent to these delegates that an approved American
20、 position re- garding standards for contact lenses and contact lens products is a necessity before an international standard can be approved by these delegates. As a result of this ob- servation, the delegates began the task of supplying information to the various ISO working groups and, at the same
21、 time, including this information and other informa- tion that will appear in ISO standards in an American document that would receive the consensus approval of the Z80 Committee on Ophthalmic Standards. The culmi- nation of this dual project is seen here as ANSI Z80.18-2003. Future reviews or revi-
22、 sions of this standard will ensure that the continued participation of American delegates to ISO will be supported by a document that has received a consensus by Z80 Committee for Ophthalmic Standards. Suggestions for improvement of this standard will be welcome. They should be sent to the Optical
23、Laboratories Association, P.O. Box 2000, Merrifield, VA 22116-2000, U.S.A. Copyright American National Standards Institute Provided by IHS under license with ANSI Licensee=USN Ship Repair Facility Yokosuka/9961031100 Not for Resale, 05/08/2007 23:35:56 MDTNo reproduction or networking permitted with
24、out license from IHS -,-,- iii This standard was processed and approved for submittal to ANSI by the Accredited Standards Committee on Ophthalmic Standards, Z80. Committee approval of this standard does not necessarily imply that all committee members voted for its approv- al. At the time it approve
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