ANSI Z80.18:2016 pdf download.for Ophthalmics一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 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, andlor for alleviating discomfort of lens wear and improving lens tolerance by physical means.
ANSI Z80.18 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—20 16, Oplithalinics — contact Lenses — Standard lerminology, Tolerances, Measurements
and Phvsicochem lea! P rope dies
ANS l/AAM I/ISO TI R 111 39, Sterilization of health care products — Vocabulary
ANSIIAAM IJISO 11 607-1, Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile harrier systems. and packaging systems
ANSI/AAMI ST67, Sterilization of health care products — Requirements and guidance for selecting a sic’ rility assurance level (SAL) for products labeled “sterile”
ISO 17665-1, Sterilization of health care products — Moist heat — Part 1: Requirements for development, validation and routine comit rot of sterilization process for medical devices
ISO 111 35— 1, Sterilization of health care products — Ethylene oxide requirements for the development, validation and rou tine control of a sterilization process for medical devices
ISO 111 37— 1, Sterilization of health care products — Radiation — Part 1. Requirements for dei’elopinent, validation and routine control of a steriliz,tion process for medical devices
2.2 Informative References
FDA: Premarket Notification (510(k)) Guidance Document for contact Lens (‘are Products. US
Department of Health and Human Service. Food and Drug Administration, Center fbr 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 asepricfihli,zg for solullon 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. Dermnatol. 52, 1969.ANSI Z80.18 pdf download.