Overview
ISO 6710:2017 - Single‑use containers for human venous blood specimen collection - specifies requirements and test methods for both evacuated and non‑evacuated single‑use venous blood specimen containers. It covers materials, draw volume, design, construction, sterility, additives, marking and labelling, and container identification. The standard explicitly excludes blood collection needles, needle holders, blood culture receptacles and arterial blood gas devices used for venous blood.
Key topics and technical requirements
- Scope and exclusions: Applies to single‑use containers (tubes) for venous blood; needles and culture bottles excluded.
- Materials and visibility: Tube material must allow a clear view of contents unless light would degrade the specimen. Containers must be free from visible foreign matter on inspection.
- Draw volume: Measured per Annex A (non‑evacuated) and Annex B (evacuated); volume of water must be within ±10% of the stated draw volume or the manufacturer must demonstrate accurate results throughout shelf life.
- Design & closures: Closures must not loosen during mixing (Annex C leakage test); removable closures should be grippable without touching specimen‑contact surfaces. Considerations for transport and automation compatibility are required.
- Construction & robustness: Containers must not crack, break or leak when centrifuged at 3 000 g (or manufacturer‑specified RCF) - see Annex D. No sharp edges or projections on visual inspection.
- Sterility and microbiological state: Evacuated containers must be sterile; claims of sterility or special microbiological states for non‑evacuated containers require validated processes. Microbe‑supporting additives must be rendered non‑viable or removed.
- Additives and accessories: Nominal additive amounts must meet ranges in Annex E; containers must allow adequate mixing (free space or other means). Annex F gives recommended colour codes (informative).
- Marking and labelling: Primary packs must include manufacturer, batch number, expiry date (YYYY‑MM or YYYY‑MM‑DD), draw volume/nominal capacity, letter code/product name, “STERILE” if claimed, “Single‑use only”, storage requirements and local labelling obligations. Non‑transparent labels must not fully encircle tubes. ISO 15223‑1 symbols are referenced.
Applications and users
- Intended for medical device manufacturers, quality managers and regulatory affairs professionals designing or certifying blood collection tubes.
- Used by clinical laboratories, hospital procurement, and manufacturers of phlebotomy systems to ensure compatibility with analytical workflows, centrifugation, sterility and labelling practices.
- Useful for test method developers, conformity assessors and supply chain auditors evaluating single‑use venous blood specimen containers.
Related standards
- ISO 15223‑1 (symbols for medical device labelling) is normative referenced.
- Historical and regional documents (e.g., EN 14820) influenced development; Annex F provides non‑mandatory colour‑coding guidance to support harmonization.
Keywords: ISO 6710:2017, single‑use containers, venous blood specimen, evacuated tubes, non‑evacuated tubes, draw volume, sterility, additives, labelling, test methods.
