Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 065 Date of Entry 12/22/2025 
FR Recognition Number 6-514
Standard
ISO  1135-4 Seventh edition 2025-05
Transfusion equipment for medical use-Part 4: Transfusion sets for single use, gravity feed
Scope/Abstract
This document specifies requirements for single use transfusion gravity sets for medical use to ensure their compatibility with containers for blood and blood components as well as with intravenous equipment.

It also provides guidance on specifications relating to the quality and performance of materials used in transfusion sets, presents designations for transfusion set components, and ensures the compatibility of sets with a range of cellular and plasma blood components.
Extent of Recognition
Complete standard
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.

Note: The tests specified in section 8.3 of this standard may not sufficiently characterize the blood performance and mechanical hemolysis of your device as there are currently no acceptable haemolysis and haemoglobin concentration country specific requirements established for the United States. We encourage you to contact the review division prior to initiating your testing.
Transition Period
FDA recognition of ISO 1135-4 Sixth edition 2015-12-01 [Rec# 6-384] will be superseded by recognition of ISO 1135-4 Seventh edition 2025-05 [Rec# 6-514]. FDA will accept declarations of conformity, in support of premarket submissions, to [Rec# 6-384] until December 17, 2028. After this transition period, declarations of conformity to [Rec# 6-384] will not be accepted.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.5440 Set, Blood Transfusion Class 2 BRZ
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Industry and FDA Staff Intravascular Administration Sets Premarket Notification Submissions [510(k)] Document issued on : July 11, 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
 Rong Guo
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/
  240-402-6290
  Rong.Guo@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.
-
-