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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 029 Date of Recognition 08/20/2012 
FR Recognition Number 6-278
Standard
ISO 11040-5 Third edition 2012-02-15
Prefilled syringes - Part 5: Plunger stoppers for injectables
Scope/Abstract
This part of ISO 11040 specifies the shape, dimensions, material, performance requirements and labelling of plunger stoppers for glass barrels (single-chamber design) for injection preparations in accordance with ISO 11040-4.

Plunger stoppers specified in this part of ISO 11040 are intended for single use only.

This part of ISO 11040 is not applicable to barrier-coated plunger stoppers.

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 Injector, Pen Class 2 NSC
§880.5860 Syringe, Antistick Class 2 MEG
§880.5860 Syringe, Piston Class 2 FMF
§880.5570 Needle, Hypodermic, Single Lumen Class 2 FMI
Relevant FDA Guidance and/or Supportive Publications
FDA Guidance on the Content of Premarket Notification [510(k)] Submissions for Piston Syringes
FDA Technical Contact
 Patricia Beaston
  FDA/OMPT/CDRH/ODE/DAGID/GHDB/
  301-796-3155
  patricia.beaston@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
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