ISO 3826-4:2015

Overview

ISO 3826-4:2015 - "Plastics collapsible containers for human blood and blood components - Part 4: Aphaeresis blood bag systems with integrated features" defines performance, design and safety requirements for aphaeresis blood bag systems. The standard covers blood collection bags made from plastics collapsible containers used with automated or semi‑automated apheresis systems. It applies to systems that may include one or more integrated features such as needle‑stick protection, leucocyte filters, sampling devices and multiple storage bags for red cells, plasma, platelets or stem (polymorphonucleic) cells.

Key topics and technical requirements

ISO 3826-4:2015 addresses both product design and verification requirements to ensure safe, functional blood collection and storage. Major topics include:

• Integrated feature list:
  • Needle stick protection device
  • Leucocyte filter and sterile barrier filter
  • Pre‑ and post‑collection sampling devices
  • Red blood cell, plasma, platelet and stem‑cell storage bags
  • Connections for anticoagulant, storage solution and replacement fluid
• Design and dimensions requirements for aphaeresis bag systems and tubing
• Performance and physical tests:
  • Resistance to leakage, insertion and pull force, thermal stability, transparency and coloration
  • Water vapour transmission for prefilled containers
  • Particulate contamination limits and sterility integrity (impermeability to microorganisms)
• Chemical and biological compatibility:
  • Requirements for raw materials, additives and extractables
  • Biological testing aligned with ISO 10993 principles
• Packaging, shelf‑life, over‑package strength and labelling requirements
• Normative test annexes: chemical tests, physical tests and biological tests

Applications and users

ISO 3826-4:2015 is used to ensure safety, compatibility and regulatory compliance of aphaeresis blood bag systems. Primary users include:

• Manufacturers and designers of blood bag systems and accessories
• Quality assurance and regulatory teams preparing technical documentation and conformity evidence
• Blood banks, transfusion services and hospital procurement teams specifying collection systems
• Test laboratories performing physical, chemical and biological validation
• National regulatory authorities assessing device conformity and safety

Practical benefits include improved blood component quality, reduced contamination and identification errors, and assured compatibility with transfusion sets and automated apheresis equipment.

Related standards

• ISO 3826-1, ISO 3826-2, ISO 3826-3 (other parts of plastics collapsible containers)
• ISO 1135-4 / ISO 1135-5 and ISO 8536-4 (transfusion/infusion sets)
• ISO 10993 series (biological evaluation of medical devices)

Keywords: ISO 3826-4:2015, aphaeresis blood bag systems, plastics collapsible containers, leucocyte filter, needle stick protection, blood collection standards, blood bag design.