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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 031 Date of Entry 08/06/2013 
FR Recognition Number 10-78
ISO  11979-3 Third edition 2012-12-01
Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods
This part of ISO 11979 specifies requirements and test methods for certain mechanical properties of intraocular lenses (IOLs).

It is applicable to all types of IOLs intended for implantation in the anterior segment of the human eye, excluding corneal implants, provided that the test method is appropriate to the particular IOL design.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§886.3600 Intraocular Lens Class 3 HQL
§886.3600 Lens, Multifocal Intraocular Class 3 MFK
§886.3600 Lens, Intraocular, Toric Optics Class 3 MJP
§886.3600 Lens, Intraocular, Accommodative Class 3 NAA
§886.3600 Lens, Iris Reconstruction Class 3 NIZ
§886.4300 Lens, Guide, Intraocular Class 1 KYB
§886.4300 Folders And Injectors, Intraocular Lens (Iol) Class 1 MSS
§886.4300 Injector, Capsular Tension Ring Class 1 NCE
FDA Technical Contact
 Claudine Krawczyk
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
*These are provided as examples and others may be applicable.