Recognized Consensus Standards

Recognition List Number: 029 Publication Date: 08/20/2012

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 6-202: ISO 11810-2 First edition 2007-05-01, Lasers and laser-related equipment - Test method and classification for the laser-resistance of surgical drapes and/or patient-protective covers - Part 2: Secondary ignition. (General Plastic Surgery/General Hospital)

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)

Devices Affected:

Surgical drapes claiming laser resistance

Processes Affected:

510(k), PMA, PDP, IDE, Design Control Input

Type of Standard:

International, Vertical

Extent of Recognition:

Complete standard

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§878.4370	Cover, Barrier, Protective	Class 2	MMP
§878.4370	Drape, Microscope, Ophthalmic	Class 2	HMW
§878.4370	Drape, Patient, Ophthalmic	Class 2	HMT
§878.4370	Drape, Pure Latex Sheet, With Self-Retaining Finger Cot	Class 2	EYX
§878.4370	Drape, Surgical, Ent	Class 2	ERY
§878.4370	Drape, Urological, Disposable	Class 2	EYY
§878.4370	General Surgery Tray (Kit)	Class 2	LRO
§878.4370	Pad, Kelly	Class 2	FNW
§878.4370	Ring (Wound Protector), Drape Retention, Internal	Class 2	KGW