ISO 8536-9 Second Edition 2015-06-15

Standard Organization:

ISO 8536-9 Second Edition 2015-06-15
Infusion Equipment for Medical Use - Part 9: Fluid Lines for Single Use with Pressure Infusion Equipment

• Recognition Date: 2016-04-04
• Recognition List: 041
• Recognition Number: 6-359
• Extent: Partial recognition. The following part(s) of the standard is (are) not recognized Section 9.3 Label on shelf or multi-unit container.
• Standards Orgs: ISO International Organization for Standardization https://www.iso.org/
• STG: General Plastic Surgery/General Hospital
• FDA Tech: Mary Brooks FDA/OMPT/CDRH/ODE/DAGID/GHDB/ 301-796-6078 Mary.Brooks@fda.hhs.gov

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

ISO 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).

Code of Federal Regulations:

Regulation Number	Device Name	Device Class	Product Code
§880.5440	Set, Administration, Intravascular	Class 2	FPA

FDA Guidance:

Intravascular Administration Sets Premarket Notification Submissions [510(k)] - Guidance for Industry and FDA , Issued July 2008.