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

New Search Back To Search Results
Recognition List Number: 030 Publication Date: 01/15/2013 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 10-75: ISO 11979-7/Amendment 1:2012, Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations. (Ophthalmic)

Date of Standard: 2012. 
Address of Standards Organization:
  International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
  SWITZERLAND
CDRH Office and Division Associated with Recognized Standards:
OFFICE OF DEVICE EVALUATION (ODE)
Devices Affected:
Intraocular Lenses (IOL)
Processes Affected:
PMA, IDE, PDP, HDE, Design Control Input
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard
Related CFR Citations and Product Codes:
Regulation
Number		 Device Name Device
Class		 Product
Code
§886.3600 Intraocular Lens Class 3 HQL
§886.3600 Lens, Intraocular, Toric Optics Class 3 MJP
§886.3600 Lens, Iris Reconstruction Class 3 NIZ
§886.3600 Lens, Multifocal Intraocular Class 3 MFK
§886.3600 Lens,Intraocular,Accommodative Class 3 NAA
 
Relevant Guidance:
There is no relevant guidance developed at this time.
FDA Technical Contact:
  Don Calogero
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2500
  Silver Spring MD 20993
  301/796-6483
  Email: don.calogero@fda.hhs.gov
* In the United States, copies of this standard can be obtained from:
  American National Standards Institute (ANSI)*
  25 West 43rd Street
  4th Floor
  New York, NY 10036
-
-