ISO 6717:2021

Overview

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 (excluding blood). The standard covers primary containment and preservation of human-derived specimens for in vitro diagnostic (IVD) examination (e.g., CSF, urine, saliva, sputum, faeces, tissue samples, infected bodily fluids). It excludes forensic specimen containers, cryo‑preservation devices, samples for nucleic acid testing, swabs and auxiliary devices.

Key topics and technical requirements

• Scope and definitions: Clear terms for container, receptacle, closure, evacuated container, draw volume, filling capacity, additive, etc.
• Materials: Receptacle transparency when visual inspection is required; manufacturers must disclose potential elemental/substance interferences.
• Filling capacity / draw volume:
  • Non‑evacuated containers: water added must be within ±10% of the filling capacity (Annex A).
  • Evacuated containers: water added must be within ±10% of the draw volume (Annex B); manufacturers must ensure accuracy throughout shelf life.
• Graduation lines: Graduation accuracy must be between 90% and 110% of indicated volume (Annex A).
• Design and construction:
  • Closures must resist loosening and leakage (leak tests in Annex C).
  • Containers intended for centrifugation must withstand 3 000 g or the manufacturer‑specified RCF without breaking or leaking (Annex D).
  • Label durability, compatibility with automation/transport, and safe removal of closures are required.
• Sterility and microbiological state: Sterilization is mandatory when the device contacts a patient fluid pathway, is intended for culture, or contains culture media; validated processes required.
• Additives: Manufacturers must validate additive choice, efficacy, form and concentration; containers with additives require provisions for mixing.
• Marking and labelling: Visibility of specimen, stability of labels across stated temperature ranges, and use of symbols (see ISO 15223-1) are addressed.

Applications and who uses this standard

ISO 6717:2021 is used by:

• Manufacturers of single‑use specimen containers (design, production, labeling, test methods)
• Regulatory and quality teams for compliance and technical documentation
• Clinical laboratories and hospital procurement assessing container suitability for specific specimen types
• Test laboratories performing conformity testing against Annex A–D methods
• Device designers integrating containers with automation and transportation systems

Practical use cases include validating container draw/fill volumes, specifying closure performance, ensuring centrifuge compatibility, and documenting additive and sterility claims.

Related standards

• ISO 6710 - requirements for single‑use human venous blood specimen containers
• ISO 15223-1 - symbols for medical device labeling

Keywords: ISO 6717:2021, in vitro diagnostic medical devices, specimen containers, evacuated containers, non-evacuated containers, filling capacity, draw volume, additives, sterility, centrifugation, medical device labeling.