SIST EN ISO 3826-1:2019/A1:2023 PDF

Overview

EN ISO 3826-1:2019/A1:2023 is the CEN-endorsed amendment to the international standard for plastics collapsible containers for human blood and blood components - Part 1: Conventional containers. Published April 2023 and prepared by ISO/TC 76 in collaboration with CEN/TC 205, this amendment adds requirements and clarifications for the instructions for use, freezing (primarily plasma-freezing bags) and ionizing irradiation of blood bags. The amendment is intended to be adopted as a national standard across CEN member bodies.

Key topics and technical requirements

• Instructions for use: Manufacturers must state whether a plastics container is intended for freezing and/or irradiation and reference applicable regulatory guidance (e.g., EDQM).
• Freezing (plasma-focused):
  • Test condition: container filled to half nominal capacity with water (per ISO 3696).
  • Must withstand slow freezing and storage to −80 °C for 24 h, immersion at (37 ± 2) °C for 60 min, and return to (23 ± 2) °C.
  • Post‑test compliance with specified clauses (e.g., physical integrity and leakage tests) is required.
  • Shock/blast freezing requires separate validation.
  • Use of refrigerant solutions is permitted if a protective bag prevents direct contact with the container.
• Ionizing irradiation (irradiated blood components):
  • Test condition: container filled to nominal capacity (containers >350 ml limited to 350 ml for the test).
  • Containers must withstand the maximum irradiation dose specified in the amendment and meet post‑irradiation performance requirements.
  • Integrity and performance following irradiation must be validated for the intended application.
• Referenced test methods: Water quality per ISO 3696 and other clauses from ISO 3826‑1 (as cited) apply.

Applications and who uses this standard

• Medical device and blood bag manufacturers: design, testing and labeling of plastic blood bags intended for freezing or irradiation.
• Blood banks and transfusion services: selection and qualification of containers for plasma freezing and storage or for irradiated blood components.
• Quality assurance / validation engineers: develop validation protocols for freeze‑thaw cycles, blast freezing, refrigerant handling and irradiation processes.
• Regulatory and procurement teams: ensure compliance with harmonized European and international requirements for transfusion and infusion equipment.

Related standards and references

• ISO 3826 series (other parts)
• ISO 3696 (water for laboratory use)
• EDQM Guide to preparation, use and quality assurance of blood components
• ISO/TC 76 and CEN/TC 205 publications

Keywords: EN ISO 3826-1:2019/A1:2023, plastics collapsible containers, blood bags, plasma freezing, irradiation, blood components, validation, transfusion equipment.