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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 047 Date of Entry 08/21/2017 
FR Recognition Number 10-103
Standard
ANSI  Z80.18-2016 (R2021)
American National Standard for Ophthalmics - Contact Lens Care Products - Vocabulary, Performance Specifications, and Test Methodology
Scope/Abstract
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.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§886.5918 Products, Contact Lens Care, Rigid Gas Permeable Class 2 MRC
§886.5928 Sterilizer, Soft-Lens, Thermal, Battery-Powered Class 2 HRC
§886.5928 Sterilizer, Soft-Lens, Thermal, Ac-Powered Class 2 HRD
§886.5928 Accessories, Soft Lens Products Class 2 LPN
§886.5928 Case, Contact Lens Class 2 LRX
§886.5928 Accessories, Solution, Ultrasonic Cleaners For Lenses Class 2 LYL
Relevant FDA Guidance and/or Supportive Publications*
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


Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 J. Angelo Green
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  301-796-6860
  angelo.green@fda.hhs.gov
 Yasith Nanayakkara
  FDA/OC/CDER/ORP/DIDP/PDB/
  301-796-5029
  yasith.nanayakkara@fda.hhs.gov
Standards Development Organization
ANSI American National Standards Institute https://www.ansi.org/
FDA Specialty Task Group (STG)
Ophthalmic
*These are provided as examples and others may be applicable.
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