ANSI Z80.18-2016 pdf free download
ANSI Z80.18-2016 pdf free download.Ophthalmics – Contact Lens Care Products – Vocabulary, Performance Specifications, and Test Methodology.
1 Scope This American National Standard applies to contact lens care products (CLCP) which are marketed for use with hard (PMMA), rigid gas permeable (RGP), enhanced oxygen permeable materials, and soft hydrophilic contact lenses. These products are intended for use in the care of contact lenses: e.g., rinsing, storing, disinfection, conditioning, neutralization, cleaning, hydration, and/or for alleviating discomfort of lens wear and improving lens tolerance by physical means. This standard provides test methodology to be used in developing performance specifications of CLCP by function and where appropriate provides acceptable performance specifications for specific products. It also addresses general requirements for CLCP based upon physical state of the marketed product (solutions, granules, and tablets), the packaging configuration (including conventional plastic container, aerosol container, form-fill-seal, or blister pack), and mode of use (unit dose or multi-dose). 2 References The following standards contain provisions which, through reference in this text, constitute provisions of this American National Standard. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on this standard are encouraged to investigate the possibility of applying the most recent editions of the standards listed below. Members of IEC and ISO maintain registers of currently valid standards. 2.1 Normative References ANSI Z80.20-2016, Ophthalmics – Contact Lenses – Standard Terminology, Tolerances, Measurements and Physicochemical Properties ANSI/AAMI/ISO TIR 11139, Sterilization of health care products – Vocabulary ANSI/AAMI/ISO 11607-1, Packaging for terminally sterilized medical devices – Part 1: Requirements for materials, sterile barrier systems, and packaging systems ANSI/AAMI ST67, Sterilization of health care products – Requirements and guidance for selecting a sterility assurance level (SAL) for products labeled “sterile”
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 Devices 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 Health 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 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 have 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 Products 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 microorganisms, prevent their proliferation and/or prevent their pathogenic action. 3.1.3 Antimicrobial agent: Compound capable of antimicrobial activity.
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 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 physical 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 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 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.
