Recognized Consensus Standards

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

Part B: SUPPLEMENTARY INFORMATION

Recognition Number 6-273: ISO 23908 First edition 2011-06-11, Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling. (General Plastic Surgery/General Hospital)

Date of Standard: 2011.

Address of Standards Organization:

International Organization for Standardization (ISO)*

1, Rue de Varembe

Case Postale 56

CH 1211 Geneva 20, 0

SWITZERLAND

CDRH Offices and Divisions Associated with Recognized Standards:

(1)	OFFICE OF DEVICE EVALUATION (ODE)

(2)	OFFICE OF SURVEILLANCE AND BIOMETRICS (OSB)

(3)	OFFICE OF SCIENCE AND ENGINEERING LABORATORIES (OSEL)

(4)	OFFICE OF COMPLIANCE (OC)

Devices Affected:

Medical devices with sharps injury prevention features

Processes Affected:

510(k), PMA, IDE, Pre-IDE, HDE, Design Control Input

Type of Standard:

Horizontal, International

Extent of Recognition:

Complete standard and any annexes with these exceptions:

Section 2, Normative references
The following standards are not FDA-recognized:
- ISO 3951 (all parts), Sampling procedures for inspection by variables
- ISO 16269-6, Statistical interpretation of data - Part 6: Determination of statistical tolerance intervals

Informative Annex A:
FDA recommends the use of the Sample Size Determination of the Simulated Use Section in Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features, 2005.

Related CFR Citations and Product Codes:

Regulation Number	Device Name	Device Class	Product Code
§872.4730	Needle, Dental	Class 1	DZM

Regulation Number	Device Name	Device Class	Product Code
§880.5200	Catheter, Umbilical Artery	Class 2	FOS
§880.5200	Catheter,Intravascular,Therapeutic,Short-Term Less Than 30 Days	Class 2	FOZ
§880.5200	Heparin, Vascular Access Flush	Class 2	NZW
§880.5200	Peripheral Catheter Insertion Kit	Class 2	OWL
§880.5200	Saline, Vascular Access Flush	Class 2	NGT
§880.5200	Water, Vascular Access Flush	Class 2	NZX

Regulation Number	Device Name	Device Class	Product Code
§880.5440	Adminstration Set Docking Station	Class 2	ODI
§880.5440	Check Valve, Retrograde Flow (In-Line)	Class 2	MJF
§880.5440	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	Class 2	ONB
§880.5440	Filter, Infusion Line	Class 2	FPB
§880.5440	Intravenous Extension Tubing Set	Class 2	OJA
§880.5440	Microfilter, Blood Transfusion	Class 2	CAK
§880.5440	Set, Administration, Intravascular	Class 2	FPA
§880.5440	Set, Blood Transfusion	Class 2	BRZ
§880.5440	Set, I.V. Fluid Transfer	Class 2	LHI
§880.5440	Stopcock, I.V. Set	Class 2	FMG
§880.5440	Tubing, Fluid Delivery	Class 2	FPK

Regulation Number	Device Name	Device Class	Product Code
§880.5570	Container, Sharps	Class 2	MMK
§880.5570	Needle, Hypodermic, Single Lumen	Class 2	FMI
§880.5570	Needle, Hypodermic, Single Lumen, Reprocessed	Class 2	NKK
§880.5570	Port, Intraosseous, Implanted	Class 2	MHC

Regulation Number	Device Name	Device Class	Product Code
§880.5725	Accessories, Pump, Infusion	Class 2	MRZ
§880.5725	Pump, Infusion	Class 2	FRN
§880.5725	Pump, Infusion, Analytical Sampling	Class 2	LZF
§880.5725	Pump, Infusion, Elastomeric	Class 2	MEB
§880.5725	Pump, Infusion, Enteral	Class 2	LZH
§880.5725	Pump, Infusion, Gallstone Dissolution	Class 2	MHD
§880.5725	Pump, Infusion, Insulin	Class 2	LZG
§880.5725	Pump, Infusion, Insulin Bolus	Class 2	OPP
§880.5725	Pump, Infusion, Ophthalmic	Class 2	MRH
§880.5725	Pump, Infusion, Pca	Class 2	MEA

Regulation Number	Device Name	Device Class	Product Code
§880.5860	Injector, Pen	Class 2	NSC
§880.5860	Syringe, Antistick	Class 2	MEG
§880.5860	Syringe, Piston	Class 2	FMF
§880.5860	Syringe, Piston, Reprocessed	Class 2	NKN

Regulation Number	Device Name	Device Class	Product Code
§880.5965	Port & Catheter, Implanted, Subcutaneous, Intravascular	Class 2	LJT
§880.5965	Port Introducer Kit	Class 2	OKE
§880.5965	Port, Protector/Cushion	Class 2	OBK

Regulation Number	Device Name	Device Class	Product Code
§880.5970	Catheter,Intravascular,Therapeutic,Long-Term Greater Than 30 Days	Class 2	LJS
§880.5970	Implanted Subcutaneous Securement Catheter	Class 2	OKC
§880.5970	Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position	Class 2	OMF
§880.5970	Tunneled Catheter Remover	Class 2	ODY

Regulation Number	Device Name	Device Class	Product Code
§880.6920	Introducer, Syringe Needle	Class 2	KZH

Regulation Number	Device Name	Device Class	Product Code
§880.6960	Ear Irrigation Kit	Class 1	OGQ
§880.6960	Syringe, Irrigating (Non Dental)	Class 1	KYZ