BS EN ISO 22870:2016

What is ISO 22870 —Point-of-care testing (POCT) about?  

ISO 22870 is an international standard that focuses on point-of-care testing and requirements. 

ISO 22870 gives specific requirements applicable to point-of-care testing. The requirements of ISO 22870 can be applied when POCT is carried out in a hospital, clinic, and by a healthcare organization providing ambulatory care.  

ISO 22870 can be applied to transcutaneous measurements, the analysis of expired air, and in vivo monitoring of physiological parameters.  

Note: Patient self-testing in a home or community setting is excluded, but elements of ISO 22870 can be applied. 

Who is ISO 22870 —Point-of-care testing (POCT) for? 

ISO 22870 on point-of-care-testing is useful for: 

• To anyone who carrying out POCT in hospitals and clinics 
• Healthcare organization that provides ambulatory care 
• In vitro diagnostic and laboratories 
• Health diagnostic centres 

Why should you use ISO 22870—Point-of-care testing (POCT)?  

Traditional examinations of a patient’s body fluids, excreta, and tissues are carried out generally in the controlled and regulated environment of a recognized medical laboratory. The introduction of quality management systems and accreditation of these laboratories are gaining increasing interest. 

ISO 22870 covers advanced technologies that have resulted in compact, easy-to-use in vitro diagnostic (IVD) medical devices that make it possible to carry out some examinations at, or close to, the location of the patient. Point-of-care/near-patient testing may benefit the patient as well as healthcare facilities. 

Risk to the patient and the facility can be managed by a well-designed, fully implemented in ISO 22870 that facilitates: 

• Evaluation of new or alternative POCT instruments and systems 
• Evaluation and approval of end-user proposals and protocols 
• Purchase, installation, and maintenance of equipment 
• Maintenance of consumable supplies and reagents 
• Training, certification, and recertification of POCT system operators 
• Quality control and quality assurance 

ISO 22870 provides its users and organization bodies with the basis, for their activities that recognize the competence of POCT facilities. 

What’s changed since the last update?  

BS EN ISO 22870:2016 supersedes BS EN ISO 22870:2006, which is withdrawn. BS EN ISO 22870:2016 includes some technical changes with respect to previous edition. These include: 

• Inclusion of cross-references to the applicable clauses in ISO 15189:2012