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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 6-478
ISO 11608-1:2022
Needle-based injection systems for medical use - Requirements and test methods - Part 1: Needle-based injection systems
This document specifies requirements and test methods for Needle-Based Injection Systems (NISs) for single-patient use intended to deliver discrete volumes (bolus) of medicinal product, which can be delivered through needles or soft cannulas for intradermal, subcutaneous and/or intramuscular delivery, incorporating pre-filled or user-filled, replaceable or non-replaceable containers.
This document applies in cases where the NIS incorporates a prefilled syringe. However, stand-alone prefilled syringes defined by ISO 11040-8 are not covered by this document (see exclusions below).
It is important to note that other functions and characteristics of the prefilled syringe, such as dose accuracy, are subject to the requirements (delivered volume) in ISO 11040-8 and not this document, unless the addition impacts the delivery function (e.g. a mechanism that intends to restrict or stop the plunger movement, which would limit the dose delivered). In that case, the system is completely covered by this document and applicable requirements of the ISO 11608 series.
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FDA recognition of ISO 11608-1 Third edition 2014-12-15 Rec# 6-341 will be superseded by recognition of of ISO 11608-1:2022 Rec# 6-478. FDA will accept declarations of conformity, in support of premarket submissions, to Rec# 6-341 until July 9, 2023. After this transition period, declarations of conformity to Rec# 6-341 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 and FDA Staff: Technical Consideration for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products, issued June 2013.
FDA Technical Contact
 Kyran Gibson
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.