ANSI Z80.18-2016 pdf free download – Contact Lens Care Products – Vocabulary, Performance Specifications, and Test Methodology.
This American National Standard applies to contact lens care products (CLCP) which are marketed for usewith 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, andor for alleviating discomfort oflens wear and improving lens tolerance by physical means.
This standard provides test methodology to be used in developing performance specifications of CLCP byfunction and where appropriate provides acceptable performance specifications for specific products. Italso 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 ofthis 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 toinvestigate the possibility of applying the most recent editions of the standards listed below.Members ofIEC and Iso maintain registers of currently valid standards.
2.1Normative References
ANSIZ80.20-2016,Ophthalmics – Contact Lenses – Standard Terminology, Tolerances, Measurementsand Physicochemical Properties
ANSI/AAMI/ISO TIR 11139, Sterilization of health care products – Vocabulary
ANSI/AAMIISO 11607-1, Packaging for terminally sterilized medical devices – Part 1: Requirements formaterials, sterile barrier systems, and packaging systems
ANSI/AAMI ST67, Sterilization of health care products – Requirements and guidance for selecting asterility assurance level (SAL) for products labeled “sterile”
ISO 17665-1, Sterilization of health care products -Moist heat – Part l:Requirements for development,validation and routine control of sterilization process for medical devices
ISO 11135-1, Sterilization of health care products -Ethylene oxide requirements for the development,validation and routine control of a sterilization process for medical devices
ISO 11137-1,Sterilization of health care products – Radiation – Part l: Requirements for development,validation and routine control of a sterilization process for medical devices
ISO 11978, Ophthalmic optics – Contact lenses and contact lens care products – Labelling
21 CFR 800.10, Contact lens care solutions; 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) for 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 flexible 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 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.ANSI Z80.18 pdf download.