Overview - ISO 3826-1:2019 (Plastics collapsible containers for human blood and blood components - Part 1: Conventional containers)
ISO 3826-1:2019 specifies requirements and performance criteria for plastics collapsible, non‑vented, sterile containers (commonly called blood bags or plastics containers) used for the collection, storage, processing, transport, separation and administration of human blood and blood components. The standard covers single and multiple‑unit assemblies (double, triple, quadruple, etc.) complete with collecting tube outlet port(s), integral needle and optional transfer tube(s). It applies to containers as prepared ready for use and explicitly excludes plastics containers with an integrated filter.
Key technical topics and requirements
- Design and dimensions: Requirements for safe, convenient design that supports centrifugation and functional compatibility with transfusion sets.
- Components covered: Collecting tubes, outlet ports, integral blood‑taking needles, transfer tubes and suspension features.
- Performance and physical requirements: Sterilization, transparency, coloration, thermal stability, water‑vapour transmission, resistance to leakage, and particulate contamination.
- Chemical and biological requirements: Material disclosure to authorities (composition and additives), compatibility with anticoagulant and preservative solutions, and impermeability to microorganisms.
- Testing framework: Normative chemical, physical and biological tests are provided (Annexes A–C). Unless otherwise stated, tests apply to the container in its ready‑for‑use state.
- Packaging and labelling: Rules for over‑packaging, shipping box labelling and barcoding information to reduce identification errors and support traceability.
- Safety goals: Minimize microbiological contamination, air embolism risk, material–content interactions and errors in identification.
Practical applications
- Ensures that blood bags maintain product quality during collection, processing and transfusion.
- Guides design and quality control for manufacturers of plastics containers and sheeting.
- Provides acceptance criteria for sterilization, shelf life, and physical durability during transport and centrifugation.
- Supports risk reduction in transfusion services, blood banks and hospital blood banks through standard labelling and compatibility requirements.
Who should use this standard
- Manufacturers and suppliers of plastics blood containers and raw sheeting
- Quality, regulatory and R&D teams in medical device and blood‑product companies
- Blood banks, transfusion services and clinical procurement officers
- National regulatory authorities and conformity assessment bodies
Related standards
- ISO 1135‑4 and ISO 1135‑5 (transfusion sets for single use - gravity feed and pressure infusion compatibility)
- ISO 10993 series (biological evaluation of medical devices)
- ISO 3696 (water for analytical laboratory use)
Keywords: ISO 3826-1:2019, plastics collapsible containers, blood bags, sterile containers, blood collection, anticoagulant, preservative solutions, transfusion compatibility, medical device standard.
Open preview (PDF)Plastics collapsible containers for human blood and blood components — Part 1: Conventional containers