Review: Policies, procedures and guidelines for point-of-care testing

International standards

Page last updated: 14 May 2013

The international standard for POCT is ISO 22870, Point-of-care testing – requirements for quality and competence. This standard, produced by the International Organisation for Standardisation (ISO), gives specific requirements applicable to POCT and is intended to be used in conjunction with ISO 15189, Medical laboratories – particular requirements for quality and competence. The requirements of ISO 22870 “apply when POCT is carried out in a hospital, a clinic, or healthcare organisation providing ambulatory care”.6

Patient self-testing is excluded from ISO 22870, but is covered specifically in ISO 15197 In vitro diagnostic test systems – requirements for blood glucose monitoring systems for self- testing in managing diabetes mellitus, and ISO 17593 Clinical laboratory testing and in vitro medical devices – requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy.

The term standard is itself defined by ISO as a document describing … “a set of rules that control how people develop and manage materials, products, services, technologies, processes, and systems.” ISO standards are developed by technical committees whose members represent many countries and professional groups and generally have very broad international support. Australia's representative (member organization) to ISO is Standards Australia (see item below, National standards and guidelines), which also provides a similar definition for the term standard.10

Appendix 3 provides a list of international and Australian standards which contain laboratory or POCT quality procedures.