What is ISO 15747- Plastic containers for intravenous injections about?
ISO 15747 is an international standard that discusses plastic containers for intravenous injections to ensure the safe handling of intravenous injections.
ISO 15747 specifies requirements for the safe handling and the physical, chemical and biological testing of plastic containers for parenteral.
ISO 15747 applies to plastic containers for parenteral 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 ISO 15747.
Who is ISO 15747- Plastic containers for intravenous injections for?
ISO 15747 on the plastic containers for intravenous injections is relevant to:
- Intravenous injections manufacturers and suppliers
- Government regulatory for specific countries
- Healthcare industry
Why should you use ISO 15747- Plastic containers for intravenous injections?
Plastic containers are used for the storage and transportation of intravenous injections to ensure prevent damage to intravenous injections.
ISO 15747 assists by setting minimum and specific requirements for producing plastic containers for intravenous injections to ensure expected quality is maintained.
ISO 15747 provides a recognized solution for the protection of consumers’ health, safety, and the environment.
With compliance and obedience to ISO 15747, you can enhance the efficacy of plastic containers and manufacture a standardized product.
What’s changed since the last update?
BS EN ISO 15747:2019 supersedes ISO 15747:2010, which is withdrawn, BS EN ISO 15747:2019 has made some technical changes compared to ISO 15747:2010. These include:
- The text of the Introduction has been moved as NOTE to the end of the Scope.
- A metallic reference spike has been defined, in Annex D, to harmonize the measurement of insertion point functional properties, for orientation and comparison purposes between different containers.
- The test for tightness of the injection point after piercing with a cannula has been revised to better define acceptance criteria.
- The wording of the titles of requirements and related tests procedures has been harmonised for better clarity.