Standards Committee

DI - Devices for Injection Committee (U.S. TAG to ISO/TC 76 and ISO/TC 84)

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Description

The AAMI DI - Devices for Injection Committee provides input into international standards by acting as the mirror committee and U.S. TAG to ISO/TC 76 - Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use and ISO/TC 84 - Devices for administration of medicinal products and catheters. 

ISO/TC 76 develops essential performance and safety standards related to containers (such as infusion bottles and bags, injection vials, ampoules, glass cylinders, cartridges, pre-fillable syringes, etc.) application systems (such as giving sets, non-electrically driven portable infusion devices, blood collection systems, etc.) and accessories for infusion, transfusion, injection and blood processing in blood banks, terms, definitions, requirements and test methods for these devices, specifications and test methods for quality and performance of their materials and components (such as elastomeric closures, caps and ports, pipettes, etc.) and quality management systems for primary packaging materials.  

ISO/TC 84 - Devices for administration of medicinal products and catheters which develops essential performance and safety standards related to performance of metered devices and supplies intended for administration of medicinal products, and standardization of syringes, needles, and intravascular catheters.



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