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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 10-60: ISO 11981 Second edition 2009-07-01, ophthalmic optics -- contact lenses and contact lens care products -- determination of physical compatibility of contact lens care products with contact lenses. (Ophthalmic)

Date of Standard: 2009. 
Address of Standards Development Organization:
 International Organization for Standardization (ISO)*
  1, Rue de Varembe
  Case Postale 56
  CH 1211 Geneva 20, 0
 
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:
Contact lenses and contact lens care products
Processes Affected:
510(k), PMA, IDE, PDP, HDE, Design Control Input
Type of Standard:
 Vertical, International
Extent of Recognition:
Complete standard and any annexes.
Related CFR Citations and Product Codes:
Regulation
Number
Device Name Device
Class
Product
Code
§886.5916 Lens, Contact (Orthokeratology) Class 2 MUW
§886.5916 Lens, Contact (Other Material) - Daily Class 2 HQD
§886.5916 Lens, Contact, Orthokeratology, Overnight Class 3 NUU
§886.5916 Lens,Contact(Rigid Gas Permeable)-Extended Wear Class 3 MWL
§886.5918 Products, Contact Lens Care, Rigid Gas Permeable Class 2 MRC
§886.5925 Lens, Contact, (Disposable) Class 2 MVN
§886.5925 Lens, Contact, For Color Vision Deficiency Class 2 NCZ
§886.5925 Lens, Contact, For Reading Discomfort Class 2 NIC
§886.5925 Lenses, Soft Contact, Daily Wear Class 2 LPL
§886.5925 Lenses, Soft Contact, Extended Wear Class 3 LPM
§886.5925 System,In-Office Tinting,Contact Lenses Class 2 MZD
§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:
Premarket Notification [510(k)] Guidance Document for Daily Wear Contact Lenses. Issued May 1994

Guidance for Industry Premarket Notification [510(k)] Guidance Document for Contact Lens Care Products. Issued May 1, 1997

Green, J.A., Phillips, K.S., Hitchins, V.M., Lucas, A.D., Shoff, M.E., Hutter, J.C., Rorer, E.M., & Eydelman, MB. (2012). Material properties that predict preservative uptake for silicone hydrogel contract lenses. Eye and Contact Lens, 38 (6), 350-357.

Hutter, J.C., Green, J.A., & Eydelman, M.B. (2012). Proposed Silicone Hydrogel Contact Lens Grouping System for Lens Care Product Compatibility Testing. Eye and Contact Lens, 38(6), 358-362.
FDA Technical Contact:
 Joseph C. Hutter
  FDA/CDRH/ODE
  10903 New Hampshire Avenue Building 66, Room 2458
  Silver Spring MD 20993
  301/796-6499
  email: joseph.hutter@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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