ISO 3826-1 Plastic Foldable Containers for Human Blood and Blood Components - Part 1: Conventional Containers

The ISO 3826-1 “Plastic foldable containers for human blood and blood components – Part 1: Conventional containers” standard, published by the International Organization for Standardization (ISO), describes requirements, including performance requirements, for foldable, ventless, sterile plastic containers with collection tube outlet ports, integrated needles, and optional transfer tubes, intended for the collection, storage, processing, transport, separation, and administration of blood and blood components. Plastic containers may contain anticoagulant or preservative solutions depending on the intended application.

This standard also applies to multiple plastic container units, e.g., double, triple, quadruple, or multi-unit. Unless otherwise specified, all tests described in this standard apply to ready-to-use plastic containers. This standard does not apply to plastic containers with integrated filters.

In the world of medical devices and blood transfusion systems, precision, safety, and reliability are undeniable. One of the critical standards guaranteeing these qualities in blood collection and storage systems is ISO 3826-1, the international standard for plastic collapsible containers for human blood and blood components.

This standard is part of a multi-part international standard developed for transfusion, infusion, and injection equipment for medical and pharmaceutical use. This standard includes requirements relating to the materials, design, performance, and labelling of disposable plastic bags used for collecting, storing, transporting, and processing human blood and blood components such as whole blood, red blood cells, plasma, and platelets.

These containers are typically made of polyvinyl chloride (PVC) plasticized with di(2-ethylhexyl) phthalate (DEHP) or alternative plasticizers, and contain integrated tubes, needles, and anticoagulant solutions.

The ISO 3826-1 standard applies to conventional blood bag systems with the following characteristics:

• Sterile and non-pyrogenic.
• Using liquid anticoagulant/preservative solutions (e.g., CPD, CPDA-1, SAG-M)
• Including donor tubes, transfer tubes, and access ports.
• Disposable ones for blood collection and component separation.

The following are outside the scope of this standard:

• Apheresis vessels
• Containers for blood derivatives (e.g., albumin, immunoglobulins)
• Containers that do not contain liquid anticoagulant
• Multi-bag systems with advanced functions (within the scope of ISO 3826-4)

The basic requirements of the ISO 3826-1 standard are defined as follows:

• Materials:
• It must be biocompatible and hemocompatible.
• Plasticizer migration limits (especially DEHP)
• There should be no toxic leakage under normal use.
• Resistance to sterilization (typically steam or ethylene oxide)
• Physical performance:
• Leakage: There should be no leakage under 30 kPa pressure.
• Tensile strength: Must be able to withstand centrifugal forces.
• Drop test: When filled, it must withstand a drop from a height of 1,2 m.
• Centrifugation: There should be no tearing at 5.000 x g.
• Volume accuracy: Should be plus/minus 10% of the nominal volume.
• Biological security:
• The sterility assurance level should be 10-6.
• The endotoxin limit should not exceed 0,5 EU/mL.
• Hemolysis: Maximum 0,8% (red blood cells) after 42 days of storage.
• Anticoagulant / preservative solution:
• Sensitive composition (e.g., CPD, citrate-phosphate-dextrose)
• pH value, osmolality and stability characteristics
• Volume accuracy plus/minus 5 percent.
• Labeling and packaging:
• The following must be clearly defined: volume, type of anticoagulant, expiry date, lot number, and sterility declaration.
• Instructions for use
• Unique device identifier compatibility is encouraged.

The ISO 3826-1 standard is considered important for the following reasons:

• Patient safety: Prevents hemolysis, contamination, and transfusion reactions.
• Global compatibility: Enables the worldwide use of blood bags from different manufacturers.
• Compliance with legal regulations: Where required or referenced are as follows:
• EU Medical Devices Regulation (MDR)
• US FDA 21 CFR 864.9225 standard
• World Health Organization guidelines for the safety of blood transfusions.
• Japanese Medicines and Medical Devices Agency standards
• Supply chain reliability: Ensures that blood banks can store components under verified conditions.

Leading blood bag manufacturers certify their products according to the ISO 3826-1 standard. Compliance is verified as follows:

• ISO 13485 standard certified quality systems
• Third-party testing
• Notified body audits (for CE marking)

Blood centers in many countries around the world rely on ISO-compliant bags to ensure transfusion safety.

In conclusion, the ISO 3826-1 standard is more than just a technical specification; it is a cornerstone of modern transfusion medicine. By setting rigorous standards for design, materials, and performance, it ensures that every unit of donated blood is collected and stored with maximum safety and effectiveness. As the healthcare sector moves towards phthalate-free, sustainable, and digitally integrated blood collection systems, this standard will continue to evolve and support global blood supply chains.

For many years, our organization, with its competent and experienced staff, has been understanding the needs of its clients, providing the advanced testing services they require, and assisting in the establishment, implementation, and improvement of management systems. Within this framework, we also provide testing services to businesses in accordance with the “ISO 3826-1 Plastic collapsible containers for human blood and blood components - Part 1: Conventional containers” standard.