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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 054 Date of Entry 07/06/2020 
FR Recognition Number 6-439
Standard
ISO 7886-2 Second edition 2020-04
Sterile hypodermic syringes for single use - Part 2: Syringes for use with power-driven syringe pumps
Scope/Abstract
This document specifies requirements for sterile single-use hypodermic syringes of nominal capacity 1 ml and above, made of plastic materials and intended for use with power-driven syringe pumps.
This document does not apply to syringes with auto-disable syringe features (ISO 7886-3[2]), syringes for use with insulin (ISO 8537[3]), single-use syringes made of glass, syringes prefilled with the injection by the manufacturer and syringes supplied with the injection as a kit for filling by a pharmacist. It does not address compatibility with injection fluids.
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FDA recognition of ISO 7886-2 First edition 1996-05-15 [Rec# 6-68] will be superseded by recognition of ISO 7886-2 Second edition 2020-04 [Rec# 6-439]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-68] until July 11, 2021. After this transition period, declarations of conformity to [Rec# 6-68] will not be accepted.
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
FDA Technical Contacts
 Michael Simpson
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/
  301-796-4070
  Michael.Simpson@fda.hhs.gov
 Rong Guo
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/
  240-402-6290
  Rong.Guo@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.
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