Overview
EN ISO 6717:2021 - In vitro diagnostic medical devices - Single‑use containers for the collection of specimens from humans other than blood - specifies requirements and test methods for specialized single‑use evacuated and non‑evacuated specimen containers used as the primary containment and preservation of non‑blood human specimens for in vitro diagnostic (IVD) examination. Examples covered include CSF, faeces, saliva, sputum, urine, tissue samples and other bodily fluids. The standard excludes containers for forensic use, cryo‑preservation, nucleic‑acid testing samples and swabs.
Keywords: EN ISO 6717:2021, in vitro diagnostic medical devices, single‑use containers, specimen collection, non‑blood specimens
Key topics and technical requirements
EN ISO 6717:2021 defines terminology, material and design expectations, and laboratory test methods. Major technical topics include:
- Materials: visibility requirements for receptacles and instructions when materials could interfere with analysis.
- Filling capacity and draw volume: definitions and tests for correct specimen/additive ratios and evacuated draw volumes (see Annex A and B).
- Graduation and fill indicators: marking requirements to enable correct filling and volume estimation.
- Design and construction: receptacle, closure and accessory definitions and performance expectations.
- Sterility and microbiological state: requirements when sterility or specific microbiological conditions are necessary.
- Additives: requirements for preservatives and reagents placed inside containers, and labelling of additive‑to‑specimen ratios.
- Marking and labelling: mandatory information, expiry date and instructions for use (referenced ISO 15223‑1 for symbols).
- Test methods: normative annexes include tests for leakage from closures (Annex C) and robustness for centrifugation (Annex D).
Applications and practical value
This standard is practical for:
- Manufacturers and product designers of IVD specimen containers - to design, verify and document container performance (capacity, closure integrity, compatibility).
- Quality and regulatory teams - to prepare technical documentation demonstrating compliance with recognized test methods and labelling requirements.
- Clinical laboratories and procurement - to specify and select containers suitable for particular specimen types and diagnostic workflows.
- Test/validation laboratories - to perform standardised tests (fill/draw volume, leakage, centrifugation robustness).
Using EN ISO 6717:2021 helps reduce pre‑analytical errors, improve sample integrity, and supports consistent specimen handling across clinical and diagnostic settings.
Related standards
- ISO 6710 - requirements and tests for single‑use human venous blood specimen containers (related blood‑specimen standard).
- ISO 15223‑1 - symbols to be used with medical device information (normative reference cited).
- Terminology references such as ISO 15189 are used for specimen definitions.
For manufacturers and laboratories working with non‑blood human specimens, EN ISO 6717:2021 is the key reference for designing, testing and labelling single‑use specimen containers.