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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 6-361
Standard
ISO 8536-11 Second Edition 2015-06-15
Infusion Equipment for Medical Use - Part 11: Infusion Filters for Single Use with Pressure Infusion Equipment
Scope/Abstract
ISO 8536-11:2015 applies to sterilized infusion filters for single use used up to 200 kPa (2 bar) on fluid lines of pressure infusion equipment and infusion set as specified in ISO 8536-8. It does not include the effectiveness of filters for separation of particles or germs.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Section 9.3 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 9.3 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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