| 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 Number | Ophthalmic |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 10-111 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Ophthalmic |
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This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| 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 |
| 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. |