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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Recognition List Number: 034 FR Publication Date: 01/30/2014 

Part B: Supplementary Information

Recognition Number 10-43: ISO 11979-8 Second edition 2006-07-01, ophthalmic implants -- intraocular lenses -- part 8: fundamental requirements. (Ophthalmic)

Date of Standard: 2006. 
Address of Standards Development 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:
510(k), PMA, IDE, PDP, HDE, Design Control Input
Type of Standard:
 International, Vertical
Extent of Recognition:
Complete standard and any annexes, with the following exceptions:

Clause 9.2 Bacterial Endotoxins, specified endotoxin level of 2.0 endotoxin limits per lens, is not recognized.

For bacterial endotoxin limits for IOLs, contact the review division.
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:
FDA Guidance for Industry Pyrogens and Endotoxins Testing: Questions and Answers, June 2012, Refer to Question 11.
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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