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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 10-86: ISO 14729 First edition 2001-04-15, ophthalmic optics - contact lens care products - microbiological requirements and test methods for products and regimens for hygienic management of contact lenses [including: amendment 1 (2010]. (Ophthalmic)

Date of Standard: 2010. 
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)
Devices Affected:
Contact lens care products
Processes Affected:
510(k), PMA, IDE, PDP, HDE, Design Controls
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard and annexes with the following exceptions:

Subclause 4.1 is not recognized

Subclause 5.2 is not recognized

Subclause 5.4 of Amendment 1 is not recognized.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§886.5918 Products, Contact Lens Care, Rigid Gas Permeable Class 2 MRC
§886.5928 Accessories, Soft Lens Products Class 2 LPN
§886.5928 Accessories, Solution, Ultrasonic Cleaners For Lenses Class 2 LYL
§886.5928 Case, Contact Lens Class 2 LRX
§886.5928 Sterilizer, Soft-Lens, Thermal, Ac-Powered Class 2 HRD
§886.5928 Sterilizer, Soft-Lens, Thermal, Battery-Powered Class 2 HRC
Relevant Guidance:
Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, Issued May 1, 1997
FDA Technical Contact:
 Denise Hampton, Ph.D
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2402
  Silver Spring MD 20993
  301/796-6860
  email: denise.hampton@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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