ISO 11981 Second edition 2009-07-01

Standard Organization:

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

Recognition Date	2014-01-30
Recognition List	034
Recognition Number	10-60
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:

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Scope:

Code of Federal Regulations:

Regulation Number	Device Name	Device Class	Product Code
§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
§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
§886.5918	Products, Contact Lens Care, Rigid Gas Permeable	Class 2	MRC
§886.5916	Lens, Contact (Orthokeratology)	Class 2	MUW
§886.5916	Lens, Contact (Other Material) - Daily	Class 2	HQD
§886.5916	Lens, Contact (Rigid Gas Permeable), Extended Wear	Class 3	MWL
§886.5916	Lens, Contact, Orthokeratology, Overnight	Class 3	NUU

FDA Guidance:

Premarket Notification [510(k)] Guidance Document for Daily Wear Contact Lenses, May 12, 1994.

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