Overview
EN ISO 3826-3:2007 (identical to ISO 3826-3:2006) is a CEN-adopted international standard that specifies requirements and performance criteria for integrated features on plastic, collapsible, non‑vented, sterile blood bag systems used to collect, process and store human blood and blood components. It supplements ISO 3826‑1 (conventional containers) by addressing multiple‑unit systems and integrated components. Tests in this standard apply to the container “as prepared ready for use.” The standard does not cover automated blood collection systems.
Key topics and technical requirements
- Integrated features covered
- Leucocyte filter (LCF) - filters integrated as whole‑blood or component filters; designed to reduce leukocyte content and may operate by gravity or pressure at ambient or 4 °C. Manufacturers must provide usage parameters (delay to filtration, capacity, temperature, filtration height, pressure, centrifugation suitability).
- Pre‑donation sampling device (PDS) - integrated in the donor line to collect first‑draw samples into evacuated tubes or a collection pouch. If a pouch is included, minimum capacity is 35 ml; the device shall allow a mean flow rate ≥ 50 ml/min when tested per ISO 3826‑1.
- Top‑and‑bottom bag (TBB) - multiple bag design enabling separation of plasma (top) and red cell concentrate (bottom) after centrifugation; compatible with press/automated separation systems.
- Platelet storage bag (PSB) - must provide good gas permeability (O2/CO2) and support platelet storage under controlled temperature with agitation; platelet quality assessment is based on pH, swirling, hypotonic shock response and aggregation.
- Needle stick protection device (NPD) - integrated donor‑needle safety mechanism; manufacturers must give usage instructions and note that NPDs may be subject to national rules.
- Air content rules - air inside filter subassemblies or pre‑donation pouches may be excluded from air‑volume calculations if design prevents air reaching the final product; limits apply to final storage containers.
- Testing application - all specified tests apply to ready‑for‑use systems; chemical, physical and biological tests from ISO 3826‑1 are referenced where applicable.
Applications and practical value
- Ensures safety, compatibility and performance of multi‑bag blood collection systems used in blood banks, transfusion services, hospital blood centers and mobile collection units.
- Guides manufacturers in design, labeling and instructions for integrated features (filters, sampling devices, storage bags, safety needles).
- Supports regulators, procurement teams and testing laboratories in product evaluation and conformity assessment for medical device directives (notably relationship to EU Directive 93/42/EEC is addressed in the EN adoption).
Who uses this standard?
- Blood bag and medical device manufacturers
- Blood banks, transfusion services and hospital laboratories
- Regulatory authorities and conformity assessment bodies
- Test laboratories and QA/validation teams
- Procurement and clinical engineering professionals
Related standards
- ISO 3826‑1:2003 - Plastics collapsible containers: Conventional containers (normative reference)
- ISO 3826‑2 - graphical symbols (under preparation at time of publication)
- EU Medical Device Directive references (Annex ZA relationship to 93/42/EEC)
Keywords: EN ISO 3826-3, ISO 3826-3, plastics collapsible containers, blood bag systems, leucocyte filter, pre-donation sampling device, platelet storage bag, needle stick protection, blood components, blood banking, medical device standard.
