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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 031 Date of Recognition 08/06/2013 
FR Recognition Number 6-294
Standard
ISO 11608-3 Second edition 2012-10-01
Needle based injection systems for medical use - Requirements and test methods - Part 3: Finished containers
Scope/Abstract
This part of ISO 11608 is applicable to containers that are provided pre-filled, or that are to be filled by the user

with medicinal products intended by the manufacturer to be used with needle-based injection systems (NIS),

as covered by ISO 11608.

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
§880.6920 Introducer, Syringe Needle Class 2 KZH
§880.5860 Injector, Pen Class 2 NSC
§880.5860 Syringe, Antistick Class 2 MEG
§880.5860 Syringe, Piston Class 2 FMF
§880.5860 Syringe, Piston, Reprocessed Class 2 NKN
Relevant FDA Guidance and/or Supportive Publications
Guidance for Industry: Container Closure Systems for Packaging Human Drugs and Biologics Issued May 1999

Guidance on the Content of Premarket Notification {510(k)} Submissions for Piston Syringes. Issued April 1993
FDA Technical Contact
 Elaine Mayhall
  FDA/OMPT/CDRH/ODE/DAGID/INCB/
  301-796-6301
  Elaine.Mayhall@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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