ISO 11979-6 Third edition 2014-10-01

Standard Organization:

ISO 11979-6 Third edition 2014-10-01
Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing

Recognition Date2015-08-14
Recognition List040
Recognition Number10-95
Extent Complete standard
Standards Orgs ISO International Organization for Standardization https://www.iso.org/
STG Ophthalmic
FDA Tech  Claudine Krawczyk   FDA/OMPT/CDRH/ODE/DOED/ICIB/   301-796-6860   claudine.krawczyk@fda.hhs.gov

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 part of ISO 11979 specifies tests by which the shelf-life of sterile intraocular lenses (IOLs) in their final packaging can be determined. These tests include procedures to establish the stability of IOLs in distribution and storage.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§886.3600 Intraocular Lens Class 3 HQL
§886.3600 Lens, Intraocular, Accommodative Class 3 NAA
§886.3600 Lens, Intraocular, Toric Optics Class 3 MJP
§886.3600 Lens, Iris Reconstruction Class 3 NIZ
§886.3600 Lens, Multifocal Intraocular Class 3 MFK
Unclassified Lens, Intraocular, Phakic Class 3 MTA

FDA Guidance:

There is no relevant guidance developed at this time.


© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.