ISO 15747:2010
Plastic containers for intravenous injections
ISO 15747:2010 contains requirements that relate to the safe handling and the physical, chemical and biological testing of plastic containers for parenterals.
ISO 15747:2010 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.
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Scope
Normative references
Terms and definitions
Requirements
Physical requirements
Manufacturing process compatibility
Resistance to temperature, pressure and leakage
Resistance to dropping
Transparency
Water vapour permeability
Particulate contamination
Cover
Access port
Adhesion strength of the infusion device and impermeability
Injection point
Hanger
Identification
Chemical requirements
Requirements for the raw container or the sheeting
Requirements for the test fluid
Biological requirements
Impermeability for microorganisms
Migration/tolerance
Identification
Application of tests
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Scope
Normative references
Terms and definitions
Requirements
Physical requirements
Manufacturing process compatibility
Resistance to temperature, pressure and leakage
Resistance to dropping
Transparency
Water vapour permeability
Particulate contamination
Cover
Access port
Adhesion strength of the infusion device and impermeability
Injection point
Hanger
Identification
Chemical requirements
Requirements for the raw container or the sheeting
Requirements for the test fluid
Biological requirements
Impermeability for microorganisms
Migration/tolerance
Identification
Application of tests