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Recognized Consensus Standards

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 051 Date of Entry 01/14/2019 
FR Recognition Number 6-410
Standard
ISO 8536-6 Third edition 2016-12-01
Infusion equipment for medical use - Part 6: Freeze drying closures for infusion bottles
Scope/Abstract
ISO 8536-6:2016 specifies the shape, dimensions, material, performance requirements and labelling for the type of closure for infusion bottles, as described in ISO 8536-1, that is used in connection with the freeze-drying (or lyophilization) of drugs and biological materials.
The dimensional requirements are not applicable to barrier-coated closures.
Closures specified in this document are intended for single use only.
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
§880.5440 Set, I.V. Fluid Transfer Class 2 LHI
Relevant FDA Guidance and/or Supportive Publications*
Intravascular Administration Sets Premarket Notification Submissions [510(k)] - Guidance for Industry and FDA Staff, Issued July 2008.
FDA Technical Contact
 Alan Stevens
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/
  301-796-6294
  Alan.Stevens@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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