ISO 20658:2023

Overview

ISO 20658:2023 specifies requirements and good-practice recommendations for the collection and transport of samples for medical laboratory examinations. Applicable to medical laboratories and service providers involved in pre‑examination processes (examination request, patient preparation and identification, sample collection and transport), this standard supports consistent, safe and reliable handling of diagnostic specimens. It excludes blood and blood products intended for transfusion but can cover donor samples for testing. International, national or regional regulations may also apply.

Key topics and technical requirements

ISO 20658 covers the full pre‑analytical workflow and includes detailed requirements in areas such as:

• General requirements and ethical conduct (impartiality, confidentiality, patient rights)
• Structural requirements (legal entity, facility manager responsibilities, risk and emergency management)
• Resource requirements (personnel competence, training and records; facility design; equipment, reagents and consumables)
• Process requirements across the pre‑examination phase:
  • Test selection, request handling and urgent requests
  • Patient identification, reception and information
  • Patient preparation and informed consent
  • Sample collection procedures (including phlebotomy, capillary and pediatric collection, arterial puncture and vascular access devices)
  • Sample identification, integrity and stability (labelling, stabilization and storage)
  • Packaging and transport (chain of custody, transport conditions and quality/safety monitoring)
  • Infection prevention and biosafety (PPE, hand hygiene, safe disposal and cleaning)
• Management system requirements (evaluation of pre‑examination processes, quality indicators, customer feedback and continual improvement)

Practical applications

ISO 20658 helps organizations to:

• Standardize specimen collection and transport protocols to reduce pre‑analytical errors
• Define staff training, competence assessment and documentation requirements
• Ensure sample integrity and traceability during transport and storage
• Implement biosafety and infection‑control measures for personnel and patients
• Monitor quality indicators and manage nonconformities in pre‑examination processes

Who should use this standard

• Medical laboratories (clinical chemistry, microbiology, pathology)
• Independent sample collection centers and courier/transport service providers
• Hospital phlebotomy units, outpatient clinics and point‑of‑care testing programs
• Biobanks involved in sample collection and transport
• Quality and compliance teams responsible for laboratory pre‑analytics

Related standards and regulations

ISO 20658 should be implemented alongside applicable national/regional regulations and other laboratory standards (for example, standards for medical laboratory quality and safety). Organizations should review local transport rules (for infectious or hazardous specimens) and harmonize procedures accordingly.

Keywords: ISO 20658, sample collection, sample transport, medical laboratory, pre‑examination, specimen integrity, phlebotomy, biosafety, laboratory quality.