ANSI Z80.18-2016 For Ophthalmics C Contact Lens Care Products C Vocabulary Performance Specifications and Test Methodology (VC).pdf

1、American National Standardfor Ophthalmics Contact Lens Care Products Vocabulary, Performance Specifications,and Test MethodologyANSI Z80.18-2016ANSIZ80.18-2016ANSIZ80.18-2016Revision ofANSI Z80.18-2010American National Standardfor Ophthalmics Contact Lens Care Products Vocabulary, Performance Specif

2、ications,and Test MethodologySecretariatThe Vision CouncilApproved December 6, 2016Published January 31, 2017American 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 h

3、avebeen met by the standards developer.Consensus is established when, in the judgement of the ANSI 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

4、. Consensus requires that allviews and objections be considered, and that a concerted effort be 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 manuf

5、acturing, marketing, purchasing, or usingproducts, processes, or procedures not conforming to the 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 rig

6、ht or authority to issue aninterpretation of an American National Standard in the name of the AmericanNational 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 Nationa

7、l Standard may be revised orwithdrawn at any time. The procedures of the American National StandardsInstitute 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

8、or writing the AmericanNational Standards Institute.American National StandardPublished byThe Vision Council1700 Diagonal RoadSuite 500Alexandria, VA 22314Copyright 2017 by The Vision CouncilAll rights reserved.No part of this publication may be reproduced in anyform, in an electronic retrieval syst

9、em or otherwise,without prior written permission of the publisher.Printed in the United States of AmericaDeveloped byThe Accredited Committee Z80 for Ophthalmic Standards -The Vision CouncilZ80 Secretariat1700 Diagonal RoadSuite 500Alexandria, VA 22314iContentsPageForeword ii1 Scope. 12 References.

10、13 Vocabulary. 33.1 General Terms Relating to Contact Lens Care Products - ISO 18369-1 . 33.2 Specific Terms Relating to Contact Lens Care Products - ISO 18469-1 . 54 General Specifications of Contact Lens Care Products 75 Standard Test Methods 85.1 Physicochemical Methods . 85.1.1 Preservative Upta

11、ke and Release - ISO 11986. 85.1.2 Determination of Shelf-life - ISO 13212 . 85.1.3 Lens Compatibility - ISO 11981 . 95.1.4 Cleaning Effectiveness - FDA Guidance 95.2 Toxicology 95.2.1 in vitro Cytotoxicity - ISO 10993-5 . 95.2.2 Acute Ocular Irritation - USP/NF XXII, ISO 10993-10 105.2.3 Acute Oral

12、 Toxicity - FDA Guidance 105.2.4 Sensitization (Guinea Pig MaximizationTest) - FDA Guidance, ISO 10993-10 . 105.2.5 in vivo Ocular Biocompatibility - ISO 9394. 115.2.6 Toxicology Tests for Containers and Plastic Accessories - Current USP, ISO 10993-10 115.3 Microbiology. 115.3.1 Sterility - FDA Guid

13、ance 115.3.2 Validation of Sterilization of Solutions and Containers . 125.3.3 Microbial Limits Non-sterile Solids - ISO 14534 sterility 21 CFR 800.12, Contact lens care solutions and tablets; Tamper-resistant packaging 21 CFR 820.30, Design controls 21 CFR Part 58, Good laboratory practice (GLP) fo

14、r nonclinical laboratory studies The United States Pharmacopeia, National Formulary, United States Pharmacopeial Convention, Rockville, MD 20852 The United States Pharmacopeia, Current USP, United States Pharmacopeial Convention, Rockville, MD 20852 ASTM F17-13a, Standard terminology relating to fle

15、xible barrier packaging PDA TR no. 22, Process simulation testing for aseptically filled products 2.2 Informative References FDA: Premarket Notification (510(k) Guidance Document for Contact Lens Care Products. US Department of Health and Human Service, Food and Drug Administration, Center for Devic

16、es and Radiological Health FDA: Guidance for Industry: Container and Closure System Integrity Testing in lieu of Sterility Testing as a Component of Stability Protocol for Sterile Products. US Department of Health and Human Service, Food and Drug Administration, Center for Devices and Radiological H

17、ealth Validation of aseptic filling for solution drug products. Technical Monograph No. 22. Parenteral Drug Association Magnusson, B. and Kligman, A. M. The Identification of Contact Allergens by Animal Assay. The Guinea Pig Maximization Test. J. Invest. Dermatol. 52, 1969 3 Vocabulary The following

18、 is a list of general and specific terms relating to contact lens care products. It is not intended to be a comprehensive listing of all possible terms relating to these products. This section does, however, contain the important terms and definitions applicable to contact lens care products which h

19、ave been defined and used within the text of other national and international standards. In the interest of international harmonization, whenever possible, the terms and definitions have been harmonized with those used in international standards. 3.1 General Terms Relating to Contact Lens Care Produ

20、cts Reference: ISO 18369-1: Ophthalmic optics Contact lenses Vocabulary, classification system, and recommendations for labelling 3.1.1 Active ingredient: Component present in sufficient quantity that relates to an intended purpose. 3.1.2 Antimicrobial activity: Ability to kill/destroy/inactivate mi

21、croorganisms, prevent their proliferation and/or prevent their pathogenic action. 3.1.3 Antimicrobial agent: Compound capable of antimicrobial activity. 4 ANSI Z80.18-2016 3.1.4 Aseptic processing: Handling of sterile product, containers and/or devices in a controlled environment, in which the air s

22、upply, materials, equipment and personnel are regulated to maintain sterility NOTE This includes sterilization by membrane filtration that cannot be separated from the subsequent aseptic process (ISO 13408-1). For aseptic processing, there is not a sterility assurance level but a maximum contaminati

23、on rate (determined by media fill validation). 3.1.5 Batch: Defined quantity of bulk, intermediate or finished product that is intended or purported to be uniform in character and quality, and which has been produced during a defined cycle of manufacture (ISO 11137-1). 3.1.6 Bioburden: Population of

24、 viable microorganisms on a raw material, component, a finished product and/or a package (ANSI/AAMI/ISO 17665-1). NOTE Bioburden is expressed as the total viable count (TVC), or colony forming units (CFU, cfu) per lens or tablet, or CFU per ml of solution. 3.1.7 Container Closure Integrity: The phys

25、ical capability of a given package to protect its contents with the desired level of protection over a defined period of service. A barrier to physical, microbiological or chemical challenges. (ASTM F17-13a) 3.1.8 Expiration date or expiry date: Period of time, designated by the manufacturer, beyond

26、 which the product should not be first used. 3.1.9 Inoculum: Suspension of known organisms. 3.1.10 Intended purpose: Use for which a device is intended according to the information supplied by the manufacturer on the labeling, in the instructions and/or in promotional materials. 3.1.11 Labeling: All

27、 information given on any label, the primary container, the secondary carton or in a leaflet supplied with the product. 3.1.12 Performance: Suitability of a device to achieve its intended purpose. 3.1.13 Preservative: Component intended to prevent the growth of microorganisms on a product. 3.1.14 Pr

28、imary packaging or primary container or shipping package: Element of the packaging system that maintains the sterility or cleanliness of the product (ANSI/AAMI/ISO 17665-1). NOTE Primary packaging is intended for storage and protection of the finished product for the duration of the labeled shelf-li

29、fe or until the integrity of the package has been compromised. 3.1.15 Shelf life: Specified period of time from the date of manufacture of a product to its labeled expiration date. 3.1.16 Stasis: Inhibition of microbial growth. 3.1.17 Sterile: Free of viable micro-organisms (ANSI/AAMI/ISO 11135-1).

30、NOTE In practice no such absolute statement regarding the absence of micro-organisms can be proven. The nature of microbial death is described by an exponential function. Therefore, the presence of viable micro-organisms on any individual item can be expressed in terms of probability. Although this

31、probability may be reduced to a very low number, it can never be reduced to zero. 3.1.18 Sterility assurance level (SAL): Probability of a single viable microorganism being present on a product unit after sterilization (ANSI/AAMI/ISO 11135-1). NOTE SAL is normally expressed in the form 10-n. When ap

32、plying this quantitative value to assurance of sterility, an SAL of 10-6 has a lower numerical value but provides a greater assurance of sterility than an SAL of 10-3. 5 ANSI Z80.18-2016 3.1.19 Tamper-evident package: Package having an indicator or barrier to entry which, if damaged, breached or mis

33、sing, can reasonably be expected to provide evidence to practitioners or users that the package may have been opened. 3.2 Specific Terms Relating to Contact Lens Care Products 3.2.1 Abrasive cleaner: Suspension in sufficient concentration used to facilitate cleaning of contact lenses by friction enh

34、ancement. 3.2.2 Blister pack: Disposable primary container consisting of a thin molded depression of material containing a product sealed with appropriate material. 3.2.3 Conditioning solution: Liquid preparation formulated for soaking and storage of a contact lens for the intended purpose of mainta

35、ining the lens in a condition suitable for reuse. NOTE Conditioning solutions are generally formulated with antimicrobial agents and primarily intended for use in the hygienic management of rigid contact lenses. 3.2.4 Contact lens care regimen: Series of processes specified by the lens or care produ

36、ct manufacturer and used by the lens wearer to maintain ocular health, lens condition, comfort and vision. 3.2.5 Contact lens cleaning: Process of removing surface contaminants from a contact lens. NOTE Cleaning is usually the first step in the hygienic management of a reusable contact lens. Chemica

37、l agents (e.g., surfactants) are often employed in contact lens cleaning products to facilitate the removal of foreign matter from a contact lens. 3.2.6 Contact lens accessory: Article intended specifically by its manufacturer to be used with a contact lens to enable the lens to be used in accordanc

38、e with its intended purpose. 3.2.7 Contact lens care product: Contact lens accessory intended for use in maintaining the safety and performance of a contact lens after opening and removal of the lens from its original shipping package. NOTE This term includes all devices recommended for use in the h

39、ygienic management of contact lenses, for hydrating contact lenses, or for alleviating discomfort of contact lens wear by physical means. 3.2.8 Contact lens disinfecting agent(s): Chemically or physically active ingredient(s) in contact lens disinfection. 3.2.9 Contact lens disinfection: Chemical or

40、 physical process to reduce the number of viable microorganisms on a contact lens to a level which is neither harmful to ocular health nor to the quality of contact lenses and accessories. NOTES (1) Bacterial spores, Acanthamoeba and some viruses may not necessarily be inactivated during the contact

41、 lens disinfection process. (2) See ISO 14729 for definitions for “contact lens disinfecting product” and “contact lens disinfecting regimen” and requirements associated with these terms. 3.2.10 Contact lens disinfecting product: Product that possesses biocidal activity (kills, destroys or inactivat

42、es), meeting the primary criteria of the stand-alone test specified in ISO 14729. 3.2.11 Contact lens disinfecting regimen: Contact lens care regimen designed to meet both the secondary criteria of the stand-alone test and the regimen test in ISO 14729. 3.2.12 Contact Lens Rinsing: Act of removing p

43、hysical and chemical contaminants from a contact lens by allowing the flow of a suitable liquid over the surfaces of the lens. 6 ANSI Z80.18-2016 NOTE A minimum time for rinsing lenses is generally recommended by the manufacturer in the labeling of a rinsing solution to achieve its intended purpose.

44、 3.2.13 Discard date or in-use period (deprecated): Specified period of time from first use when a products continued use should cease. 3.2.14 Enzymatic cleaner protein remover: Liquid or solid preparation containing one or more enzymes as active ingredients with the intended purpose of reducing ads

45、orbed and absorbed proteins and/or lipids on a contact lens. NOTE Enzymatic cleaners are optional lens care products recommended for use in the hygienic management of contact lenses. 3.2.15 Hygienic management: Procedure by which contact lenses are maintained in a condition for safe reuse. 3.2.16 In

46、-use stability: Ability of a contact lens or contact lens care product to retain its performance and safety from first opening to its discard date. 3.2.17 Lens case: Container in which contact lenses are stored either dry or in a suitable solution by the user after removal from the primary container

47、. 3.2.18 Lubricating and rewetting solution, in-eye drops, rewetting drops, comfort drops (deprecated): Liquid preparation intended for occasional use directly in the eye by a contact lens wearer for alleviating discomfort of lens wear and improving lens tolerance by physical means. NOTE The term “c

48、omfort drops” is deprecated because it is a registered trademark of a contact lens care product in some countries and is no longer a generic term. 3.2.19 Multi-dose solution: Liquid preparation in a primary container whose volume allows the user to expel an appropriate amount of the product on more

49、than one occasion. 3.2.20 Multipurpose solution Combination solution (deprecated): Liquid preparation which has more than one claimed function in the hygienic management of a contact lens. NOTE For the labeling of multipurpose solutions, the product must perform the following functions: daily cleaning, chemical disinfection, rinsing and storage of contact lenses. 3.2.21 Neutralization: Process by which active ingredients in a contact lens care product which may compromise ocular tissue are rendered inactive and/or non-toxic. NOTE There is no implicatio