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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Recognition List Number: 018 Publication Date: 09/12/2007 

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 10-48: ISO 11979-5 Second edition 2006-06-01, Ophthalmic implants -- Intraocular lenses -- Part 5: Biocompatibility. (Ophthalmic)

Date of Standard: 2006. 
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)
DIVISION OF OPHTHALMIC AND EAR, NOSE AND THROAT DEVICES (DOED)
Devices Affected:
Intraocular lenses (IOL)
Processes Affected:
PMA, IDE, PDP, HDE, Design Control Input
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete standard and any annexes.
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
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