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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 034 Date of Entry 01/30/2014 
FR 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
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
§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, 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
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.