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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 043 Date of Entry 06/27/2016 
FR Recognition Number 6-364
Standard
ISO 8537 Third edition 2016-03-15 Sterile single-use syringes, with or without needle, for insulin
Scope/Abstract
ISO 8537:2016 specifies requirements and test methods for empty, sterile, single-use syringes, with or without needles, made of plastic materials and intended solely for the injection of insulin, with which the syringes are filled by the end user. This International Standard covers syringes intended for single-use only in humans and with insulins of various concentrations.
The insulin syringes specified in this International Standard are intended for use (i.e. insulin injection) immediately after filling and are not intended to contain insulin for extended periods of time.
ISO 8537:2016 excludes single-use syringes made of glass, syringes for use with power-driven syringe pumps, syringes that are pre-filled by the manufacturer, and syringes intended to be stored after filling (e.g. in a kit intended for filling by a pharmacist).
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized
Section 5.3 Colour coding.
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
§880.5570 Needle, Hypodermic, Single Lumen Class 2 FMI
§880.5860 Syringe, Piston Class 2 FMF
Relevant FDA Guidance and/or Supportive Publications*
Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes, Issued April 1993.
FDA Technical Contact
 Mary Brooks
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/
  301-796-6078
  Mary.Brooks@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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