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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 057 Date of Entry 12/20/2021 
FR Recognition Number 6-464
Standard
ISO  11040-4 Third edition 2015-04-01
Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling [Including AMENDMENT 1 (2020)]
Scope/Abstract
This part of ISO 11040 applies to
- tubing-glass barrels (single-chamber design) for injection preparations, and
- sterilized subassembled syringes ready for filling.

It specifies materials, dimensions, quality, and performance requirements, as well as relevant test methods.

This part of ISO 11040 also specifies those components that are part of the sterilized subassembled syringe ready for filling.

Glass barrels and sterilized subassembled syringes ready for filling in accordance with this part of ISO 11040 are intended for single use only.

Components to complete the subassembled syringe, such as plunger and rod, are not specified in this part of ISO 11040.
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
§880.5570 Needle, Hypodermic, Single Lumen Class 2 FMI
§880.5860 Syringe, Piston Class 2 FMF
§880.5860 Syringe, Antistick Class 2 MEG
§880.5860 Injector, Pen Class 2 NSC
Relevant FDA Guidance and/or Supportive Publications*
FDA Guidance on the Content of Premarket Notification [510(k)] Submissions for Piston Syringes, issued April 1993.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Kyran Gibson
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/
  --
  Kyran.Gibson@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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