ISO 18259 First Edition 2014-10-01

Standard Organization:

ISO 18259 First Edition 2014-10-01
Ophthalmic optics - Contact lens care products - Method to assess contact lens care products with contact lenses in a lens case, challenged with bacterial and fungal organisms

Recognition Date2016-04-04
Recognition List041
Recognition Number10-100
Extent Complete standard
Standards Orgs ISO International Organization for Standardization https://www.iso.org/
STG Ophthalmic
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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 an antimicrobial efficacy end point methodology to determine compatibility of contact lens solutions, lens cases and hydrogel lenses for disinfection. This provides a process for evaluating compatibility of solutions used for disinfection with contact lenses and lens cases using an antimicrobial efficacy end point. Specifically, the microbiological effect of the antimicrobial agent(s) while in the presence of the lens cases and/or lenses will be evaluated as described in the soak step of the label instructions.

For practical purposes, this does not apply to oxidative systems.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§886.5928 Accessories, Soft Lens Products Class 2 LPN
§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
§886.5918 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, Issued May 1994
http://www.fda.gov/RegulatoryInformation/Guidances/ucm080928.htm

Guidance for Industry Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, Issued May 1, 1997
http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080218.pdf

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