ISO 3826-1:2019 PDF

Scope: 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.

ISO 3826-1:2019 Referenced Document

ISO 10993-4 Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood — Amendment 1
ISO 10993-5 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
ISO 1135-4 Transfusion equipment for medical use - Part 4: Transfusion sets for single use, gravity feed
ISO 1135-5 Transfusion equipment for medical use - Part 5: Transfusion sets for single use with pressure infusion apparatus
ISO 3696 Water for analytical laboratory use; Specification and test methods

2023 ISO 3826-1:2019/Amd 1:2023 Plastics collapsible containers for human blood and blood components — Part 1: Conventional containers — Amendment 1
2019 ISO 3826-1:2019 Plastics collapsible containers for human blood and blood components — Part 1: Conventional containers
2013 ISO 3826-1:2013 Plastics collapsible containers for human blood and blood components.Part 1: Conventional containers
2003 ISO 3826-1:2003 Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers