ISO 4311 First edition 1979-06-01

Standard Organization:

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

Recognition Date2015-08-14
Recognition List040
Recognition Number10-99
Extent Complete standard
Standards Orgs ISO International Organization for Standardization https://www.iso.org/
STG Ophthalmic
FDA Tech  Joseph C. Hutter   FDA/OMPT/CDRH/ODE/DOED/ICIB/   301-796-6499   joseph.hutter@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

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.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§886.5928 Accessories, Soft Lens Products Class 2 LPN
§886.5918 Products, Contact Lens Care, Rigid Gas Permeable Class 2 MRC

FDA Guidance:

There is no relevant guidance developed at this time.


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