Standards and Guidance Documents for Laboratory of Biological Risk Assessment
- FDA/CDRH guidance on Premarket notification of 510(k) for contact lens care products, 1997
- CDRH Guidance for Industry and FDA Staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)]
- CDRH Guidance for Industry and FDA Staff: Reusable medical devices: Labeling reusable medical devices for reprocessing in health care facilities.
- ISO 14729 Ophthalmic Optics- Contact lens care products-Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses
- ANSI Z80.18-2003: Contact lens care products
- AAMI TIR 12: Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: a guide for device manufacturers.
- AAMI TIR 30: Compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.
- AAMI ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities.