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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 058 Date of Entry 05/30/2022 
FR Recognition Number 6-477
Standard
ISO 11608-3:2022
Needle-based injection systems for medical use - Requirements and test methods - Part 3: Containers and integrated fluid paths
Scope/Abstract
This document specifies requirements and test methods for design verification of containers and integrated fluid paths used with Needle-Based Injection Systems (NISs) according to ISO 11608-1.
It is applicable to single and multi-dose containers either filled by the manufacturer (primary container closure) or by the end-user (reservoir) (e.g. cartridges, syringes) and fluid paths that are integrated with the NIS at the point of manufacture.
This document is also applicable to prefilled syringes (see ISO 11040-8) when used with a NIS (see also scope of ISO 11608-1:2022).
This document is not applicable to the following products:
- sterile hypodermic needles;
- sterile hypodermic syringes;
- sterile single-use syringes, with or without needle, for insulin;
- containers that can be refilled multiple times;
- containers intended for dental use;
- catheters or infusion sets that are attached or assembled separately by the user.
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FDA recognition of ISO 11608-3 Second edition 2012-10-01 Rec# 6-294 will be superseded by recognition of of ISO 11608-3:2022 Rec# 6-477.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*
1. Guidance on the Content of Premarket Notification [510(k)] Submissions for Piston Syringes, issued April 1993.
2. Guidance for Industry - Container Closure Systems for Packaging Human Drugs and Biologics, issued May 1999.

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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