Recognized Consensus Standards

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

034

Date of Entry 01/30/2014 

FR Recognition Number

6-273

Standard

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

Scope/Abstract

ISO 23908:2011 gives requirements and test methods for evaluating the performance parameters of sharps injury protection features, whether active or passive in design, for medical devices containing (sharp) hypodermic needles for single use, introducers for catheters and lancets, and other needles used in blood sampling. The sharps injury protection devices it covers may be provided integral to the device or combined with the device prior to use to achieve the sharps injury protection.
It does not give requirements for the storage and handling of the sharps protection before its intended use, or for the medical device itself.

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
§880.5200	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	Class 2	FOZ
§880.5200	Catheter, Umbilical Artery	Class 2	FOS
§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
§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
§880.6920	Introducer, Syringe Needle	Class 2	KZH
§880.5440	Administration 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
§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	Needle, Interosseous	Class 2	MHC
§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
§872.4730	Needle, Dental	Class 1	DZM
§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
§880.6960	Ear Irrigation Kit	Class 1	OGQ
§880.6960	Syringe, Irrigating (Non Dental)	Class 1	KYZ
§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

Relevant FDA Guidance and/or Supportive Publications*

Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features, CDRH issued, 2005

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.

FDA Technical Contact

 Kyran Gibson

  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/

  --

  Kyran.Gibson@fda.hhs.gov

Standards Development Organization

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

FDA Specialty Task Group (STG)

General Plastic Surgery/General Hospital

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