Overview

The standard specifies requirements, including performance requirements, for non-vented, sterile plastic collapsible containers complete with one or more collecting tube outlet port(s), integral needle, and with optional transfer tube(s) intended for the collection, storage, processing, transport, separation, and administration of blood and blood components. The plastic collapsible containers may contain anticoagulant and/or preservative solutions, depending on the application envisaged. Primarily the following modifications have been made with respect to DIN EN ISO 3826-1:2004-04: - new clauses on requirements and testing for sterile connection transfer tubing have been added; - 5.8 on the outlet port(s) has been updated with regard to good compatibility with closure-piercing devices in accordance with ISO 1135-4; - Annex C on biological tests has been completely revised. This standard has been prepared by Technical Committee ISO/TC 76 "Transfusion, infusion and injection equipment for medical and pharmaceutical use" in collaboration with Technical Committee CEN/TC 205 "Non-active medical devices", the secretariat of which is held by DIN. For this purpose, the Medical Standards Committee (NAMed), Working Committee NA 063-02-02 AA "Transfusions-/Infusionsbehältnisse und- geräte aus Kunststoffen" ("Transfusion/infusion containers and equipment made from plastics"), is responsible at DIN, the German Committee for Standardization.

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 176-04-03 AA - Transfusion/infusion containers and equipment made from plastics and disposable sample containers for the in-vitro diagnostics  

Responsible european committee

CEN/TC 205 - Non-active medical devices  

Responsible international committee

ISO/TC 76/WG 1 - Soft containers for blood, blood components and parenterals; Infusion, transfusion and blood processing equipment