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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 058 Date of Entry 05/30/2022 
FR Recognition Number 6-475
ISO 11608-4:2022
Needle-based injection systems for medical use - Requirements and test methods - Part 4: Needle-based injection systems containing electronics
This document specifies requirements and test methods for needle-based injection systems (NISs) containing electronics with or without software (NIS-Es).
The needle-based injection system containing electronics can be single use or reusable and can be operated with or without electrical/conductive connections to other devices. The system is intended to deliver medication to a patient by self-administration or by administration by one other operator (e.g. caregiver or health care provider).
This document applies to electronic accessories that are intended to be physically connected to a NIS or NIS-E according to the NIS/NIS-E intended use.
This document also applies to electronic accessories that are intended to have electrical/conductive connections to a NIS or NIS-E according to the NIS/NIS-E intended use.
This document does not specify requirements for software in programmable NIS-E.
NOTE IEC 60601-1:2005+AMD1:2012+AMD2:2020, Clause 14 addresses software life cycle processes.
This document does not specify requirements for cybersecurity.
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FDA recognition of ISO 11608-4 First edition 2006-03-15 Rec# 6-174 will be superseded by recognition of of ISO 11608-4:2022 Rec# 6-475. FDA will accept declarations of conformity, in support of premarket submissions, to Rec# 6-174 until July 9, 2023. After this transition period, declarations of conformity to Rec# 6-174 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 on the Content of Premarket Notification [510(k)] Submissions for Piston Syringes, issued April 1993.
FDA Technical Contact
 Keith Marin
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.