Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 052 Date of Entry 07/15/2019 
FR Recognition Number 10-89
Standard
ANSI  Z80.7-2013 (R2023)
American National Standard for Ophthalmic Optics - Intraocular Lenses
Scope/Abstract
This standard applies to monofocal intraocular lenses (IOLs) whose primary indication is the correction of aphakia.

This standard addresses the vocabulary, optical properties and test methods, mechanical properties and test methods, biocompatibility,
sterility, shelf-life and transport stability, and clinical investigations necessary for this type of device.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Subclause 8.2.3. Bacterial endotoxins
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.

This standard is recognized in part because:

Subclause 8.2.3 is in conflict with an existing published final guidance. See Recommendation #1 under Section V. B. Anterior Segment Solid Devices of the guidance document cited below.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§886.3600 Intraocular Lens Class 3 HQL
Relevant FDA Guidance and/or Supportive Publications*
Endotoxin Testing Recommendations for Single-Use Intraocular Ophthalmic Devices: Guidance for Industry and Food and Drug Administration Staff, Issued August 2015.

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 Contact
 Don Calogero
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  301-796-6483
  don.calogero@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.
-
-