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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 040 Date of Entry 08/14/2015 
FR Recognition Number 10-99
Standard
ISO  4311 First edition 1979-06-01
Anionic and non-ionic surface active agents - Determination of critical micellization concentration - Method by measuring surface tension with a plate, stirrup, or ring
Scope/Abstract
This International Standard specifies a method for the determination of the critical micellization concentration of anionic and non-ionic surface active agents in solution in distilled water or other aqueous systems, by measurement of the surface tension with a plate, stirrup or ring.
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
§886.5918 Products, Contact Lens Care, Rigid Gas Permeable Class 2 MRC
§886.5928 Accessories, Soft Lens Products Class 2 LPN
Relevant FDA Guidance and/or Supportive Publications*
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 Contact
 Joseph C. Hutter
  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/
  301-796-6499
  joseph.hutter@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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