ISO/TC 76 - ISO/TC 76
Standardization of transfusion, infusion and injection equipment for medical and pharmaceutical use; terms and definitions for such equipment; specifications for quality and performance of materials and components. Standardization of containers (such as infusion bottles, injection vials, ampoules, glass cylinders, cartridges, prefillable syringes, etc.) and devices ( such as giving sets, blood collecting tubes, etc.) as well as pertinent primary and secondary packaging and functional components (such as elastomeric closures, caps, pipettes and accessories) for medical and pharmaceutical use. Excluded : - empty disposable syringes and injection needles for medical use; - single-use and re-usable syringes, covered by ISO/ TC 84.
ISO/TC 76
Standardization of transfusion, infusion and injection equipment for medical and pharmaceutical use; terms and definitions for such equipment; specifications for quality and performance of materials and components. Standardization of containers (such as infusion bottles, injection vials, ampoules, glass cylinders, cartridges, prefillable syringes, etc.) and devices ( such as giving sets, blood collecting tubes, etc.) as well as pertinent primary and secondary packaging and functional components (such as elastomeric closures, caps, pipettes and accessories) for medical and pharmaceutical use. Excluded : - empty disposable syringes and injection needles for medical use; - single-use and re-usable syringes, covered by ISO/ TC 84.
General Information
ISO 3826-3:2006 specifies requirements, including performance requirements, for integrated features on plastic, collapsible, non-vented, sterile containers (blood bag systems).
The integrated features refer to:
leucocyte filter;pre-donation sampling device;top and bottom bag;platelet storage bag;needle stick protection device.
In addition to ISO 3826-1:2003, which specifies the requirements of conventional containers, ISO 3826-3:2006 specifies additional requirements for blood bag systems using multiple units.
Unless otherwise specified, all tests specified in ISO 3826-3:2006 apply to the plastic container as prepared ready for use.
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