Overview - EN ISO 13079:2011 (Westergren tubes for ESR)
EN ISO 13079:2011 specifies requirements for laboratory glass and plastics tubes (commonly called Westergren tubes or Westergren pipettes) and for tube supports used to measure the erythrocyte sedimentation rate (ESR) by the Westergren method. The standard covers both single‑use and re‑usable tubes, material and dimensional requirements, marking and labelling, and includes informative guidance on the reference Westergren procedure (Annex D). It excludes blood‑collection containers and devices developed from the Westergren principle that represent different methods.
Key topics and technical requirements
- Materials: Tubes may be rigid transparent plastics or glass of Class HGB 1/2/3 per ISO 719; transparency must allow clear observation of the blood column and red cell layer.
- Rigidity and distortion: Type tests (Annex A) limit distortion under load - ≤ 1 mm for re‑usable tubes and ≤ 1.5 mm for single‑use tubes.
- Dimensional controls: Essential dimensions for single‑use tubes include an internal diameter of 2.55 ± 0.15 mm and a measuring‑part length of 200 ± 2 mm (Table 1). Re‑usable tube dimensions and further tolerances are detailed in the standard.
- Surface and finish: Glass ends are fire‑polished or ground; plastics ends must be smooth. Tubes must be free from defects that impair observation.
- Plastics compatibility: Plastics must not adhere to blood cells, release plasticizers or mould‑release agents that alter ESR by > 6 mm in the Annex B contamination test.
- Straightness and testing: Straightness testing is defined in Annex C; other normative tests address contamination and mechanical properties.
- Graduation, inscriptions and labelling: Requirements for scales, figuring, markings and packaging information are specified (Clauses 7–9).
- Support construction: Requirements for the support that holds tubes during the 60‑minute test period are included.
Practical applications and users
- Manufacturers of laboratory glassware and single‑use/plastic diagnostic tubes use EN ISO 13079:2011 to design, test and certify Westergren tubes.
- Clinical laboratories and hospital procurement staff reference the standard when selecting ESR consumables to ensure accuracy, traceability and compatibility with the Westergren reference method.
- Quality managers and regulatory compliance teams use the specified test methods (Annexes A–C) for batch verification and product conformity.
- Test kit suppliers and designers of ESR instrumentation consult the standard to ensure tube/support interfaces and labelling meet reference‑method requirements.
Related standards
- ISO 719 - referenced for glass hydrolytic class (HGB 1/2/3).
- Standards for blood collection devices (not covered by ISO 13079) apply to primary specimen containers.
Keywords: EN ISO 13079:2011, Westergren tubes, erythrocyte sedimentation rate, ESR, laboratory glassware, single‑use, re‑usable, Westergren method.
