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ISO 15747

Plastic containers for intravenous injections

active, Most Current
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Organization: ISO
Publication Date: 1 September 2018
Status: active
Page Count: 22
ICS Code (Transfusion, infusion and injection equipment): 11.040.20
scope:

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.

NOTE In some countries, national or regional pharmacopoeias or other government regulations are legally binding and these requirements take precedence over this document.

Document History

ISO 15747
September 1, 2018
Plastic containers for intravenous injections
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...
ISO 15747
April 15, 2010
Plastic containers for intravenous injections
This International Standard contains requirements that relate to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals. This International...
ISO 15747
November 15, 2003
Plastics containers for intravenous injection
A description is not available for this item.

References

This document references:
ISO 10993-1 - Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
Published by ISO on August 1, 2018
This document specifies: — the general principles governing the biological evaluation of medical devices within a risk management process; — the general categorization of medical devices based on the...
This document references:
ISO 10993-5 - Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Published by ISO on June 1, 2009
This part of ISO 10993 describes test methods to assess the in vitro cytotoxicity of medical devices. These methods specify the incubation of cultured cells in contact with a device and/or extracts...
This document references:
ISO 1135-4 - Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed
Published by ISO on December 1, 2015
This part of ISO 1135 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...
This document references:
ISO 15510 - Stainless steels - Chemical composition
Published by ISO on May 15, 2014
This International Standard lists the chemical compositions of stainless steels agreed by ISO/TC 17/SC 4, mainly on the basis of a composition of the specifications in existing ISO, ASTM, EN, JIS,...
This document references:
ISO 2768-1 - General Tolerances - Part 1: Tolerances for Linear and Angular Dimensions without Individual Tolerance Indications First Edition; (CEN EN 22768-1: 1993)
Published by ISO on January 1, 1989
This part of ISO 2766 is intended to simplify drawing indications and it specifies general tolerances for linear and angular dimensions without individual tolerance indications in four tolerance...
This document is referenced by:
ISO 11040-6 - Prefilled syringes - Part 6: Plastic barrels for injectables and sterilized subassembled syringes ready for filling
Published by ISO on January 1, 2019
This document specifies materials, dimensions, quality, and performance requirements, as well as test methods for polymer barrels and sterilized subassembled syringes ready for filling, intended for...
This document is referenced by:
ISO 11040-6 FRENCH - Seringues préremplies — Partie 6: Cylindres en plastique pour produits injectables et seringues pré-assemblées stérilisées préremplissables
Published by ISO on January 1, 2019
A description is not available for this item.
This document is referenced by:
3826-1 AMD 1 - Plastics collapsible containers for human blood and blood components — Part 1: Conventional containers AMENDMENT 1
Published by ISO on March 1, 2023
A description is not available for this item.
This document is referenced by:
EN ISO 3826-1 - Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers
Published by CEN on October 1, 2019
This document specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers (known as plastics containers) complete with collecting tube outlet...
This document is referenced by:
E3251 - Standard Test Method for Microbial Ingress Testing on Single-Use Systems
March 15, 2023
The microbial test method outlined in this test method applies to microbial ingress risk assessment of a single-use system (SUS) or its individual components that require integrity testing either by...
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