| ISO 14729 First edition 2001-04-15 Ophthalmic optics - Contact lens care products - Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses [Including: Amendment 1 (2010] |
| Recognition Number | Ophthalmic |
| Recognition Date | 2019-01-14 |
| Recognition List | 051 |
| Recognition Number | 10-86 |
| Extent | Partial recognition. The following part(s) of the standard is (are) not recognized -Subclause 4.1 of Amendment 1, General -Subclause 5.4 of Amendment 1, Test requirements for contact lens care products without rubbing (or mechanical cleaning) and/or rinsing steps |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | Ophthalmic |
| FDA Tech | Scott Steffen FDA/OMPT/CDRH/ODE 240-402-8795 scott.steffen@fda.hhs.gov |
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 standard is recognized in part because: Subclauses 4.1 and 5.4 both conflict with Panel recommendations, an FDA letter sent to industry, and an existing published final FDA labeling guidance (section 4B), see references listed below.
This International Standard specifies two test methods for evaluating the antimicrobial activity of products to be marketed for contact lens disinfection by chemical means and for products that are part of a contact lens care regimen.
This International Standard is not applicable to the hygienic management of trial lenses.
| 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 |
| §886.5918 | Products, Contact Lens Care, Rigid Gas Permeable | Class 2 | MRC |
| 1. FDA Ophthalmic Devices Panel (June 10, 2008), minutes available online: http://web.archive.org/web/20091105204724/http://www.fda.gov/ohrms/dockets/ac/08/minutes/2008-4363m1.pdf 2. FDA letter to industry issued on May 19, 2009, available online: https://www.fda.gov/MedicalDevices/ProductsandMedicalProcedures/HomeHealthandConsumer/ConsumerProducts/ContactLenses/ucm154976.htm 3. Guidance for Industry and Food and Drug Administration Staff: Contact Lens Care Products Labeling, Issued August 15, 2010. https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM223665.pdf 4. Guidance for Industry: Premarket Notification (510(k)) Guidance Document for Contact Lens Care Products, Issued May 1, 1997. |