Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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041
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Date of Entry 04/04/2016
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FR Recognition Number
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6-359
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Standard | |
ISO 8536-9 Second Edition 2015-06-15 Infusion Equipment for Medical Use - Part 9: Fluid Lines for Single Use with Pressure Infusion Equipment |
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Scope/AbstractISO 8536-9:2015 applies to sterilized fluid lines for single use for use with pressure infusion equipment up to a maximum of 200 kPa (2 bar). The following items are covered by ISO 8536-9:2015: a) syringe pump lines (SPL); b) connecting lines (CL); c) lines with integrated injection cannula (LIC).
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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. |
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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. |
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Public Law, CFR Citation(s) and Procode(s)*
Regulation Number |
Device Name |
Device Class |
Product Code |
§880.5440 |
Set, Administration, Intravascular
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Class 2
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FPA
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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. |
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FDA Technical Contact
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Standards Development Organization
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FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital |
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*These are provided as examples and others may be applicable. |