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U.S. Department of Health and Human Services

Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 013 Date of Recognition 11/08/2005 
FR Recognition Number 6-68
Standard
ISO 7886-2 First edition 1996-05-15
Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps
Scope/Abstract
Specifies requirements for sterile single-use hypodermic syringes of nominal capacity 5 ml and above, made of plastics materials and intended for use with power-driven syringe pumps. Does not apply to syringes for use with insulin, single-use syringes made of glass, syringes prefilled with the injection by the manufacturer and syringes supplied with the injection as a doctors kid.
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
§880.5860 Syringe, Piston Class 2 FMF
§880.5725 Pump, Infusion Class 2 FRN
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
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