ISO 1135-4 Sixth edition 2015-12-01

Standard Organization:

ISO 1135-4 Sixth edition 2015-12-01
Transfusion equipment for medical use-Part 4: Transfusion sets for single use, gravity feed

Recognition Date2017-08-21
Recognition List047
Recognition Number6-384
Extent Complete standard
Standards Orgs ISO International Organization for Standardization https://www.iso.org/
STG General Plastic Surgery/General Hospital
FDA Tech  Keith Marin   FDA/OMPT/CDRH/ODE/DAGID/GHDB/   301-796-2462   keith.marin@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 1135-4:2015 specifies requirements for single use transfusion gravity sets for medical use in order to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment.

Secondary aims of ISO 1135-4:2015 are to provide guidance on specifications relating to the quality and performance of materials used in transfusion sets, to present designations for transfusion set components, and to ensure the compatibility of sets with a range of cellular and plasma blood components.

Code of Federal Regulations:

Regulation Number Device Name Device Class Product Code
§880.5440 Set, Blood Transfusion Class 2 BRZ

FDA Guidance:

Guidance for Industry and FDA Staff Intravascular Administration Sets Premarket Notification Submissions [510(k)] Document issued on : July 11, 2008


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