Overview
ISO/TS 22583:2024 is a Technical Specification from ISO that sets requirements and recommendations for supervisors and operators of point-of-care testing (POCT) equipment used where POCT is performed without medical laboratory training, supervision or support. Published as the second edition in 2024, it focuses on ensuring safe, reliable and interpretable POCT results across non-laboratory settings (self-testing is excluded). The document reflects lessons from the COVID‑19 pandemic and clarifies roles, quality processes and safety measures for POCT services.
Key topics and technical requirements
ISO/TS 22583:2024 addresses the full POCT lifecycle and includes both normative and informative annexes. Core technical topics include:
- Personnel and competence
- Roles and responsibilities of supervisors and operators
- Training, demonstrated competence and ongoing assessment (Annex A)
- POCT equipment selection
- Criteria for choosing appropriate devices and tests for the intended use (Annex B)
- Process management
- Pre‑testing: service planning, environment, consumables, equipment readiness, patient ID and consent
- Testing: procedures, internal quality control (IQC) and external quality assessment (EQA) (Annex D), problem identification and resolution
- Post‑testing: result interpretation, reporting, result recipients, cleanup and disposal
- Information management
- Confidentiality, security and record flows
- Documentation and records
- Required documents, record management, storage and correction processes (Annex C)
- Health, safety and biosafety
- Infection control, sharps handling, personal protection, waste disposal and hazard analysis (Annex E)
- Audit and oversight
- External audits and supervisory responsibilities for maintaining service quality
Practical applications - who uses this standard
ISO/TS 22583:2024 is practical for organizations implementing POCT outside traditional laboratories, including:
- Healthcare providers: hospitals, clinics, emergency services, long‑term care
- Community settings: pharmacies, outreach clinics, sporting events, workplaces
- First responders and transport (ambulance/field medicine)
- Occupational health, law enforcement and military medical services
- Device manufacturers, distributors and procurement teams seeking compliance guidance
- Quality managers, clinical supervisors and regulators overseeing POCT programs
Using this Technical Specification helps reduce errors, improve patient safety, ensure consistent IQC/EQA practices, and support defensible result interpretation and reporting.
Related standards
- Prepared by ISO/TC 212 (Medical laboratories and in vitro diagnostic systems).
- This edition supersedes ISO/TS 22583:2019 and removes references to the withdrawn ISO 22870. For integrated POCT quality systems, consult other ISO standards and national regulatory guidance as applicable.
Keywords: ISO/TS 22583:2024, point-of-care testing, POCT, supervisors, operators, IQC, EQA, biosafety, documentation, equipment selection.