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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 031 Date of Entry 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.
Transition Period
FDA recognition of ISO 11608-3 Second edition 2012-10-01 Rec# 6-294 will be superseded by recognition of of ISO 11608-3:2022 Rec# 6-477. FDA will accept declarations of conformity, in support of premarket submissions, to Rec# 6-294 until July 9, 2023. After this transition period, declarations of conformity to Rec# 6-294 will not be accepted.
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
§880.5860 Syringe, Piston, Reprocessed Class 2 NKN
§880.6920 Introducer, Syringe Needle Class 2 KZH
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

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
 Elaine Mayhall
  FDA/OC/CDRH/OPEQ/OHTIV/DHTIVB/
  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
*These are provided as examples and others may be applicable.
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