Overview
EN ISO 6710:2017 (ISO 6710:2017) specifies requirements and test methods for single‑use containers for human venous blood specimen collection. It applies to both evacuated and non‑evacuated venous blood specimen containers and covers design, materials, draw volume, sterility, additives, marking and container identification. The standard is published by ISO and adopted by CEN as EN ISO 6710:2017 and supersedes EN 14820:2004.
Note: blood collection needles, needle holders, blood culture receptacles and arterial blood gas devices are excluded.
Key topics and technical requirements
- Scope & exclusions - Defines the intended use (venous blood specimen collection) and explicitly excludes blood culture bottles and certain devices.
- Materials & construction - Requirements for container materials and basic construction to ensure safe handling and compatibility with blood specimens.
- Draw volume - Requirements and test methods for nominal liquid capacity (draw volume) for evacuated and non‑evacuated containers (normative Annexes A and B).
- Design & robustness - Design criteria for safe use (including centrifugation where applicable) and robustness tests (normative Annex D).
- Sterility & microbiological state - Clauses and tests for sterility and special microbiological conditions (Clause 8; referenced in Annex ZA).
- Additives - Requirements and recommended concentrations / liquid volumes of additives (normative Annex E) and recommended colour coding for additives and accessories (informative Annex F).
- Leakage testing - Test methods to assess container leakage during use (normative Annex C). The standard covers leakage during use but does not fully address leakage during storage or transport (see Annex ZA).
- Marking, labelling & container identification - Requirements for labels, batch/lot coding and additive identification (Clause 10–11). Some regulatory expectations (e.g., the word “LOT” preceding batch codes) are referenced in Annex ZA.
Practical applications and who uses it
- Manufacturers of single‑use evacuated and non‑evacuated blood collection tubes - for product design, validation testing and labelling.
- Quality & regulatory teams - to demonstrate conformity with essential requirements of Directive 98/79/EC for in vitro diagnostic medical devices (presumption of conformity within scope).
- Clinical laboratories & procurement - to select compliant specimen containers suitable for specific tests and centrifugation requirements.
- Test laboratories - to perform draw volume, leakage and robustness testing per the normative annexes.
- Designers and R&D - to specify additive formulations, colour coding and material choices in new products.
Related standards
- Directive 98/79/EC (in vitro diagnostic medical devices) - Annex ZA maps clauses of EN ISO 6710:2017 to essential requirements.
- ISO/TC 76 and CEN/TC 140 technical committee outputs - for related transfusion, infusion and blood processing equipment standards.
Keywords: EN ISO 6710:2017, ISO 6710:2017, single‑use containers, venous blood specimen collection, evacuated tubes, non‑evacuated tubes, draw volume, sterility, leakage test, additives, container identification.
