Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

064

Date of Entry 05/26/2025 

FR Recognition Number

6-507

Standard

ISO  23908 Second Edition 2024-12
Sharps injury protection - Sharps protection mechanisms for single-use needles, introducers for catheters and needles used for blood testing, monitoring, sampling and medical substance administration - Requirements and test methods

Scope/Abstract

This document provides requirements and test methods to evaluate the performance and usability of sharps injury protection mechanisms (SIPMs) of devices including a single use sharp, for administration and/or extraction of blood or body fluids and/or medicinal substances.
The sharps injury protection mechanisms covered by this document can be provided integral to the device or for assembly with the device prior to use.
The aim of the tests is to confirm minimization of risks of accidental sharps injury from contaminated sharps, after the period of intended use, including the path to safe disposal or recovery, where this is a legal requirement or the manufacturers' decision.
This document does not cover
- devices for medication loading and transfer, utilizing a blunt tip design, or
- invasive products whose intended use is to access small spaces, particularly ear, nose and throat, to perform ophthalmic procedures
because their SIPMs have been found to adversely affect the usability and can increase the risk for patients versus the benefit of the intended use of the device.
This document does not cover solid-core needles used for surgery (e.g. suture needles).

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.

Transition Period

FDA recognition of ISO 23908 First edition 2011-06-11 [Rec# 6-273] will be superseded by recognition of ISO 23908 Second Edition 2024-12 [Rec# 6-507]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-273] until July 4, 2027. After this transition period, declarations of conformity to [Rec# 6-273] will not be accepted.

Public Law, CFR Citation(s) and Procode(s)*

Regulation Number	Device Name	Device Class	Product Code
§872.4730	Needle, Dental	Class 1	DZM
§880.5200	Catheter, Umbilical Artery	Class 2	FOS
§880.5200	Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	Class 2	FOZ
§880.5200	Saline, Vascular Access Flush	Class 2	NGT
§880.5200	Heparin, Vascular Access Flush	Class 2	NZW
§880.5200	Water, Vascular Access Flush	Class 2	NZX
§880.5200	Peripheral Catheter Insertion Kit	Class 2	OWL
§880.5440	Set, Blood Transfusion	Class 2	BRZ
§880.5440	Microfilter, Blood Transfusion	Class 2	CAK
§880.5440	Stopcock, I.V. Set	Class 2	FMG
§880.5440	Set, Administration, Intravascular	Class 2	FPA
§880.5440	Filter, Infusion Line	Class 2	FPB
§880.5440	Tubing, Fluid Delivery	Class 2	FPK
§880.5440	Set, I.V. Fluid Transfer	Class 2	LHI
§880.5440	Check Valve, Retrograde Flow (In-Line)	Class 2	MJF
§880.5440	Administration Set Docking Station	Class 2	ODI
§880.5440	Intravenous Extension Tubing Set	Class 2	OJA
§880.5440	Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System	Class 2	ONB
§880.5570	Needle, Hypodermic, Single Lumen	Class 2	FMI
§880.5570	Needle, Interosseous	Class 2	MHC
§880.5570	Container, Sharps	Class 2	MMK
§880.5570	Needle, Hypodermic, Single Lumen, Reprocessed	Class 2	NKK
§880.5725	Pump, Infusion	Class 2	FRN
§880.5725	Pump, Infusion, Analytical Sampling	Class 2	LZF
§880.5725	Pump, Infusion, Insulin	Class 2	LZG
§880.5725	Pump, Infusion, Enteral	Class 2	LZH
§880.5725	Pump, Infusion, Pca	Class 2	MEA
§880.5725	Pump, Infusion, Elastomeric	Class 2	MEB
§880.5725	Pump, Infusion, Gallstone Dissolution	Class 2	MHD
§880.5725	Pump, Infusion, Ophthalmic	Class 2	MRH
§880.5725	Accessories, Pump, Infusion	Class 2	MRZ
§880.5725	Pump, Infusion, Insulin Bolus	Class 2	OPP
§880.5860	Syringe, Piston	Class 2	FMF
§880.5860	Syringe, Antistick	Class 2	MEG
§880.5860	Syringe, Piston, Reprocessed	Class 2	NKN
§880.5860	Injector, Pen	Class 2	NSC
§880.5965	Port & Catheter, Implanted, Subcutaneous, Intravascular	Class 2	LJT
§880.5965	Port, Protector/Cushion	Class 2	OBK
§880.5965	Port Introducer Kit	Class 2	OKE
§880.5970	Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	Class 2	LJS
§880.5970	Tunneled Catheter Remover	Class 2	ODY
§880.5970	Implanted Subcutaneous Securement Catheter	Class 2	OKC
§880.5970	Percutaneous, Implanted, Long-Term Intravascular Catheter Accessory For Catheter Position	Class 2	OMF
§880.6920	Introducer, Syringe Needle	Class 2	KZH
§880.6960	Syringe, Irrigating (Non Dental)	Class 1	KYZ
§880.6960	Ear Irrigation Kit	Class 1	OGQ

Relevant FDA Guidance and/or Supportive Publications*

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