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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 062 Date of Entry 05/29/2024 
FR Recognition Number 6-501
Standard
ISO  15747 Third edition 2018-09
Plastic containers for intravenous injections
Scope/Abstract
This document specifies requirements to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.

This document is applicable to plastic containers for parenterals having one or more chambers and having a total nominal capacity in the range of 50 ml to 5 000 ml such as film bags or blow-moulded plastic bottles for direct administration of infusion (injection) solutions.
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.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.5025 Container, I.V. Class 2 KPE
Relevant FDA Guidance and/or Supportive Publications*
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 Contacts
 David Wolloscheck
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/
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  David.Wolloscheck@fda.hhs.gov
 Sreya Tarafdar
  FDA/OC/CDRH/OPEQ/OHTIII/DHTIIIC/
  --
  Sreya.Tarafdar@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.
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