ISO 3826-1:2013
Plastics collapsible containers for human blood and blood components.Part 1: Conventional containers
- Standard No.
- ISO 3826-1:2013
- Release Date
- 2013
- Published By
- International Organization for Standardization (ISO)
- Status
- Replace By
- ISO 3826-1:2019
- Latest
- ISO 3826-1:2019/Amd 1:2023
- Scope
- This part of ISO 3826 specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile 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 may contain anticoagulant and/or preservative solutions, depending on the application envisaged.
ISO 3826-1:2013 Referenced Document
- ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
- 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 1135-4:2012 Transfusion equipment for medical use - Part 4: Transfusion sets for single use
- ISO 3696:1987 Water for analytical laboratory use; Specification and test methods
ISO 3826-1:2013 history
- 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
