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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Entry 09/17/2018 
FR Recognition Number 10-112
Standard
ISO  11986 Third edition 2017-11
Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release
Scope/Abstract
This document provides general procedures for the selection of methods, preparation of samples, and the conduct of testing for the uptake and release of preservatives from contact lenses.

NOTE 1 Due to the manifest difficulties of reproducibility when coating contact lenses with mineral and organic deposits encountered during lens wear, these methods are only applicable to new and unused contact lenses.

NOTE 2 Preservative depletion by a contact lens in the limited volume of a lens case could compromise disinfection performance. This document does not measure disinfection performance.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§886.5916 Lens, Contact (Other Material) - Daily Class 2 HQD
§886.5916 Lens, Contact (Orthokeratology) Class 2 MUW
§886.5916 Lens, Contact (Rigid Gas Permeable), Extended Wear Class 3 MWL
§886.5916 Lens, Contact, Orthokeratology, Overnight Class 3 NUU
§886.5918 Products, Contact Lens Care, Rigid Gas Permeable Class 2 MRC
§886.5925 Lenses, Soft Contact, Daily Wear Class 2 LPL
§886.5925 Lenses, Soft Contact, Extended Wear Class 3 LPM
§886.5925 Lens, Contact, (Disposable) Class 2 MVN
§886.5925 System, In-Office Tinting, Contact Lenses Class 2 MZD
§886.5925 Lens, Contact, For Color Vision Deficiency Class 2 NCZ
§886.5925 Lens, Contact, For Reading Discomfort Class 2 NIC
§886.5928 Sterilizer, Soft-Lens, Thermal, Battery-Powered Class 2 HRC
§886.5928 Sterilizer, Soft-Lens, Thermal, Ac-Powered Class 2 HRD
§886.5928 Accessories, Soft Lens Products Class 2 LPN
§886.5928 Case, Contact Lens Class 2 LRX
§886.5928 Accessories, Solution, Ultrasonic Cleaners For Lenses Class 2 LYL
Relevant FDA Guidance and/or Supportive Publications*
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 1997.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contacts
 Joseph C. Hutter
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  301-796-6499
  joseph.hutter@fda.hhs.gov
 Yasith Nanayakkara
  FDA/OC/CDER/ORP/DIDP/PDB/
  301-796-5029
  yasith.nanayakkara@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
Ophthalmic
*These are provided as examples and others may be applicable.
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