ISO 11981 Third edition 2017-11

Ophthalmic Optics - Contact Lenses And Contact Lens Care Products - Determination Of Physical Compatibility Of Contact Lens Care Products With Contact Lenses

11981 Third edition 2017-11

Standard Organization: ISO

ISO 11981 Third edition 2017-11
Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses

Recognition NumberOphthalmic
Recognition Date2018-09-17
Recognition List050
Recognition Number10-111
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 document describes the general procedure and performance criteria for assessing the physical compatibility of contact lens care products with contact lenses and for determining whether the observed changes are reversible.

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, Issued May 1994.

Guidance for Industry Premarket Notification [510(k)] Guidance Document for Contact Lens Care Products, Issued May 1997.


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