Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

031

Date of Entry 08/06/2013 

FR Recognition Number

10-78

Standard

ISO  11979-3 Third edition 2012-12-01
Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods

Scope/Abstract

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

  FDA/OC/CDRH/OPEQ/OHTI/DHTIA/

  301-796-6860

  claudine.krawczyk@fda.hhs.gov

Standards Development Organization

ISO International Organization for Standardization https://www.iso.org/

FDA Specialty Task Group (STG)

Ophthalmic

*These are provided as examples and others may be applicable.