| 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 |
| Recognition Date | 2014-01-30 |
| Recognition List | 034 |
| Recognition Number | 6-273 |
| Extent | Complete standard |
| Standards Orgs | ISO International Organization for Standardization https://www.iso.org/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | Mary Brooks FDA/OMPT/CDRH/ODE/DAGID/GHDB/ 301-796-6078 Mary.Brooks@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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.
| 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 |
| §880.6920 | Introducer, Syringe Needle | Class 2 | KZH |
| §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 |
| §880.5965 | Port & Catheter, Implanted, Subcutaneous, Intravascular | Class 2 | LJT |
| §880.5965 | Port Introducer Kit | Class 2 | OKE |
| §880.5965 | Port, Protector/Cushion | Class 2 | OBK |
| §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 |
| §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 |
| §880.5570 | 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 |
| §880.5440 | 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 |
| §880.5200 | 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 |
| §872.4730 | Needle, Dental | Class 1 | DZM |
| Guidance for Industry and FDA Staff: Medical Devices with Sharps Injury Prevention Features, CDRH issued, 2005 |