| Part B: Supplementary Information Sheet (SIS) |
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FR Recognition List Number
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034
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Date of Entry 01/30/2014
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FR Recognition Number
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6-273
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| 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 |
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Scope/AbstractISO 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. |
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| Extent of Recognition
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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. |
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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. |
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| FDA Technical Contact
|
| Standards Development Organization
|
FDA Specialty Task Group (STG)
| General Plastic Surgery/General Hospital |
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| *These are provided as examples and others may be applicable. |
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