DIN Standards Committee Health Technologies
DIN EN ISO 3826-1
Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2013); German version EN ISO 3826-1:2013
Kunststoffbeutel für menschliches Blut und Blutbestandteile - Teil 1: Konventionelle Beutel (ISO 3826-1:2013); Deutsche Fassung EN ISO 3826-1:2013
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
Responsible european committee
CEN/TC 205 - Non-active medical devices
