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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 041 Date of Entry 04/04/2016 
FR Recognition Number 6-360
Standard
ISO 8536-10 Second Edition 2015-06-15
Infusion Equipment for Medical Use - Part 10: Accessories for Fluid Lines for Single Use with Pressure Infusion Equipment
Scope/Abstract
ISO 8536-10:2015 applies to sterilized accessories for single use in fluid lines and pressure infusion equipment as specified in ISO 8536-8.
ISO 8536-10:2015 includes the following:
a) two-way stopcocks, three-way stopcocks, four-way stopcocks, and stopcocks manifold;
b) units with injection site or check valve;
c) stoppers or adapters.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Section 8.3 Label on shelf or multi-unit container.
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.

This standard is recognized in part because:
Section 8.3 is not consistent with an existing published final guidance, see Section 12, Labeling of the guidance listed below.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.5440 Set, Administration, Intravascular Class 2 FPA
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)], Issued July 2008.
FDA Technical Contact
 Mary Brooks
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/
  301-796-6078
  Mary.Brooks@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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