ANSI Z80.18-2016

Standard Organization:

ANSI Z80.18-2016
American National Standard for Ophthalmics - Contact Lens Care Products - Vocabulary, Performance Specifications, and Test Methodology

Recognition Date2017-08-21
Recognition List047
Recognition Number10-103
Extent Complete standard
Standards Orgs ANSI American National Standards Institute https://www.ansi.org/
STG Ophthalmic
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Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

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.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§886.5928 Accessories, Soft Lens Products Class 2 LPN
§886.5928 Accessories, Solution, Ultrasonic Cleaners For Lenses Class 2 LYL
§886.5928 Case, Contact Lens Class 2 LRX
§886.5928 Sterilizer, Soft-Lens, Thermal, Ac-Powered Class 2 HRD
§886.5928 Sterilizer, Soft-Lens, Thermal, Battery-Powered Class 2 HRC
§886.5918 Products, Contact Lens Care, Rigid Gas Permeable Class 2 MRC

FDA Guidance:

Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, Issued May 1, 1997

ANSI/AAMI/ISO 11137-1:2006/(R) 2010 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation, and routine control of a sterilization process for medical devices

ISO 10993-10 Third Edition 2010-08-01, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization

ISO 10993-7 Second edition 2008-10-15, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals

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