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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 043 Date of Entry 06/27/2016 
FR Recognition Number 5-108
ISO  80369-6 First Edition 2016-03-15
Small bore connectors for liquids and gases in healthcare applications - Part 6: Connectors for neuraxial applications.
This part of ISO 80369 specifies requirements for small-bore connectors intended to be used for connections in neuraxial applications. Neuraxial applications involve the use of medical devices intended to administer medications to neuraxial sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures or to monitor or remove cerebro-spinal fluid for therapeutic or diagnostic purposes.
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.
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
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.