What is ISO 3826‑1 - Conventional containers about?
ISO 3826 discusses plastic collapsible containers for human blood and blood components. ISO 3826‑1 provides the 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.
ISO 3826‑1 guidelines help ensure the quality of blood and blood components is maintained as high as necessary.
ISO 3826‑1 also applies to multiple units of plastics containers, e.g., to double, triple, quadruple, or multiple units.
Unless otherwise specified, all tests specified in ISO 3826‑1 apply to the plastics container as prepared ready for use.
Note: ISO 3826‑1 does not apply to plastics containers with an integrated filter.
Who is ISO 3826‑1 - Conventional containers for?
ISO 3826‑1 on plastic collapsible containers for human blood and blood components is useful for:
- Manufacturers of conventional containers for human blood
- Medical laboratories
- Regulatory authorities
Why should you use ISO 3826‑1 - Conventional containers?
Plastics container, of plastics material, complete with collecting tube and needle, port(s) and where applicable anticoagulant, preservative solutions, transfer tube(s), and associated container(s).
ISO 3826‑1 guideline helps you with dimensions, design, physical requirements, chemical requirements, biological requirements, packaging, and labelling for plastic collapsible containers for human blood and blood components. This helps in improving the quality of plastic collapsible containers and ensures the quality of blood and blood components is maintained as high as necessary.
What’s changed since the last update?
BS EN ISO 3826‑1:2019 supersedes ISO 3826‑1:2013, which has been withdrawn. BS EN ISO 3826‑1:2019 has some technical changes with respect to ISO 3826‑1:2013. These includes:
- In Clause 3 'Terms and definitions' four new entries have been added
- In Clause 4, the designation example has been removed
- Clause 5 'Design' has been revised, especially regarding the pilot samples, collection and transfer tube(s), blood-taking needle, and outlet port(s)
- The physical requirements in 6.2 have been slightly amended
- Clause 8 'Labelling' has been reviewed and amended with barcoding information
- Clause 8 'Labelling' has been reviewed and amended with barcoding information