What is ISO/TS 22583-Guidance on use of POCT devices about?

ISO/TS 22583 is a document that focuses on guidance for supervisors and operators of point-of-care testing (POCT) devices.

ISO/TS 22583 gives guidance for supervisors and operators of POCT services where POCT is performed without medical laboratory training, supervision or support.

ISO/TS 22583 includes the key components that should be considered to provide safe and reliable POCT results.

Who is ISO/TS 22583- Guidance on use of POCT devices for?

ISO/TS 22583 on POCT devices is useful for:

Medical industry
Medical device manufacturers
Healthcare providers
Paramedics
Pharmacies
Long-term care facilities
Outreach clinics

Why should you use ISO/TS 22583- Guidance on use of POCT devices?

Due to the ease of use and rapidness of POCT, POCT equipment is widely used as a tool for making decisions related to the health, management, or care needs of patients. Such decisions can include admission to hospital, evacuation to more appropriate care environments and directed patient management. As POCT results can be used to make important decisions about patients, it is vital that the equipment works properly to yield the correct results and that the operators are trained and competent. This requires that a quality testing structure is provided by supervisors and made available to the operators.

ISO/TS 22583 has been written in easy to understand language. The purpose of ISO/TS 22583 is to provide supervisors and operators of POCT services guidance for assessing the appropriateness of proposed POCT, test and equipment selection, as well as skill requirements for technical performance and result interpretation that can ensure that the reliability, quality and interpretation of the results produced is of a quality appropriate to the intended use.

It is recommended that manufacturers and their distributors draw this ISO/TS 22583 to the attention of purchasers of POCT equipment and encourage them to follow this document.

PD ISO/TS 22583:2019

Guidance for supervisors and operators of point-of-care testing (POCT) devices

Published:

30 Nov 2019

Withdrawn:

2 Oct 2024