This document specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers (known as plastics containers) complete with collecting tube outlet port(s), integral needle, and with optional transfer tube(s), for the collection, storage, processing, transport, separation, and administration of blood and blood components. The plastics containers can contain anticoagulant and/or preservative solutions, depending on the application envisaged.

This document is also applicable to multiple units of plastics containers, e.g. to double, triple, quadruple, or multiple units.

Unless otherwise specified, all tests specified in this document apply to the plastics container as prepared ready for use.

This document is not applicable to plastics containers with an integrated filter.

Cross References:
ISO 1135-4
ISO 10993-10
ISO 1135-5
ISO 3696
ISO 10993-11
ISO 10993-4
ISO 10993-5
ISO 3826-4
ISO/TS 23128
ISO 9626
ISO 10993 (all parts)
ISO 3826-3
DIN 13097-5
ISO 3826-2
DIN 13097-4
EN 15986
ISO 15223-1
ISO 15747:2018


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