This part of ISO 3826 specifies requirements, including the required performance characteristics, for non-ventilated, sterile plastic bags equipped with a collection tube, one or more puncture nozzles, an integrated blood collection cannula and optionally with a transfer tube or tubes and which are used for collection, storage, processing and transport , intended for the separation and administration of blood and blood components. Depending on the intended use, the plastic bags may contain anticoagulant and/or stabilizer solution. This part of ISO 3826 is also applicable to multiple systems of plastic bags, e.g. B. composed of two, three, four or more units. Unless otherwise specified, all tests specified in this part of ISO 3826 apply to the ready-to-use plastic bag. This part of ISO 3826 does not apply to plastic bags with an integrated filter.
EN ISO 3826-1:2013 Referenced Document
ISO 10993-10:2010 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization
ISO 10993-11:2006 Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-12:2012 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 10993-4:2002 Biological evaluation of medical devices - Part 4: Selection of test for interactions with blood
ISO 10993-5:2009 Biological evaluation of medical devices — Part 5: Tests for cytotoxicity: in vitro methods
ISO 1135-4:2012 Transfusion equipment for medical use - Part 4: Transfusion sets for single use
ISO 3696:1987 Water for analytical laboratory use; Specification and test methods
EN ISO 3826-1:2013 history
2023EN ISO 3826-1:2019/A1:2023 Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers - Amendment 1 (ISO 3826-1:2019/Amd1:2023)
2019EN ISO 3826-1:2019 Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers (ISO 3826-1:2019)
2013EN ISO 3826-1:2013 Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers
2003EN ISO 3826-1:2003 Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers ISO 3826-1:2003