Recognized Consensus Standards

Recognition List Number: 019 Publication Date: 12/19/2007

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 10-55: ISO 11979-6 Second edition 2007-07-15, Ophthalmic implants -- Intraocular lenses -- Part 6: Shelf-life and transport stability. (Ophthalmic)

Date of Standard: 2007.

Address of Standards Organization:

International Organization for Standardization (ISO)*

1, Rue de Varembe

Case Postale 56

CH 1211 Geneva 20, 0

SWITZERLAND

CDRH Office and Division Associated with Recognized Standards:

	OFFICE OF DEVICE EVALUATION (ODE)
	DIVISION OF OPHTHALMIC AND EAR, NOSE AND THROAT DEVICES (DOED)

Devices Affected:

Intraocular lenses (IOL)

Processes Affected:

PMA, IDE, PDP, HDE, Design Control Input

Type of Standard:

International, Vertical

Extent of Recognition:

Complete standard and any annexes with the following additional requirement:

The minimum testing for transport stability shall include physical damage assessment (clause 4.5).

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§886.3600	Intraocular Lens	Class 3	HQL
§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
§886.3600	Lens,Intraocular,Accommodative	Class 3	NAA