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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 065 Date of Entry 12/22/2025 
FR Recognition Number 5-146
Standard
ISO  80369-6 Second edition 2025-05
Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications
Scope/Abstract
This document specifies requirements for small-bore connectors intended to be used for connections in neural applications.

This document does not specify requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular standards for specific medical devices or accessories.
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FDA recognition of ISO 80369-6 First Edition 2016-03-15 [Rec# 5-108] will be superseded by recognition of ISO 80369-6 Second edition 2025-05 [Rec# 5-146]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 5-108] until December 17, 2028. After this transition period, declarations of conformity to [Rec# 5-108] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§868.5120 Catheter, Conduction, Anesthetic Class 2 BSO
§868.5140 Anesthesia Conduction Kit Class 2 CAZ
§868.5150 Needle, Conduction, Anesthetic (W/Wo Introducer) Class 2 BSP
§880.5440 Set, Administration, Intravascular Class 2 FPA
§880.5440 Administrations Sets With Neuraxial Connectors Class 2 PWH
§880.5860 Syringe, Piston Class 2 FMF
§882.1620 Device, Monitoring, Intracranial Pressure Class 2 GWM
§882.4060 Cannula, Ventricular Class 1 HCD
§882.4100 Catheter, Ventricular Class 2 HCA
§882.4100 Catheter, Ventricular (Containing Antibiotic Or Antimicrobial Agents) Class 2 NHC
§882.5550 Shunt, Central Nervous System And Components Class 2 JXG
§882.5560 External Cerebrospinal Fluid (Csf) Diversion Class 2 PCB
Relevant FDA Guidance and/or Supportive Publications*
(Website) Medical Device Connectors: https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/medical-device-connectors


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
 Scott A. Colburn
  FDA/OC/CDRH/OSPTI/ORR
  301-796-6287
  scott.colburn@fda.hhs.gov
Standards Development Organization
ISO International Organization for Standardization https://www.iso.org/
FDA Specialty Task Group (STG)
General I (QS/RM)
*These are provided as examples and others may be applicable.
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