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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 6-358
ISO 8536-8 Second Edition 2015-06-15
Infusion Equipment for Medical Use - Part 8: Infusion Sets for Single Use with Pressure Infusion Apparatus
ISO 8536-8:2015 gives users information on sterilized infusion sets for single use with pressure infusion apparatus up to a maximum of 200 kPa (2 bar).
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Section 10.3 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 10.3 is not consistent with an existing published final guidance, see Section 12, Labeling of the guidance listed below.
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff: Intravascular Administration Sets Premarket Notification Submissions [510(k)], Issued July 2008.

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
 Kyran Gibson
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.