BS EN ISO 22870:2016

BS EN ISO 22870:2016

Point-of-care testing (POCT). Requirements for quality and competence

Status : Current   Published : December 2016
Conformity to regulation : Designated



What is this standard about?

It specifies requirements that apply to point-of-care testing: that is testing performed near or at the site of a patient with the result leading to possible changes in the patient’s care. It is essential that POCT is undertaken correctly to ensure accurate and reliable results.

Who is this standard for?

This standard is relevant to anyone carrying out POCT in hospitals, clinics or where a healthcare organization provides ambulatory care. It will also be used in the IVD and laboratory markets.

Why should you use this standard?

ISO 22870 gives specific requirements applicable to POCT carried out in a hospital, clinic or by a healthcare organization providing ambulatory care. It covers aspects such as organization and management, identification and control of nonconformities and assuring the quality of examination procedures.

NOTE: ISO 22870 should be used in conjunction with ISO 15189 Medical laboratories. Requirements for quality and competence.

What’s changed since the last update?

ISO 22870 has been updated to include cross-references to the applicable clauses in ISO 15189:2012. It also includes minor editorial corrections and changes to the bibliography references.

Standard NumberBS EN ISO 22870:2016
TitlePoint-of-care testing (POCT). Requirements for quality and competence
Publication Date31 December 2016
Conformity to regulationDesignated
Normative References(Required to achieve compliance to this standard)ISO 15189:2012
Informative References(Provided for Information)EN 13532:2002, ISO/IEC 17043:2010, CLSI POCT07-A:2010, ISO 18113-5, ISO 18113-4
ReplacesBS EN ISO 22870:2006
International RelationshipsEN ISO 22870:2016,ISO 22870:2016
DescriptorsDiagnosis (medical), Quality, Laboratory testing, Quality assurance systems, Quality management, Clinical medicine, Health services, Patients, Laboratories, Health service personnel, Hospitals
Title in FrenchExamens de biologie médicale délocalisée (EBMD). Exigences concernant la qualité et la compétence
Title in GermanPatientennahe Untersuchungen (point-of-care testing, POCT). Anforderungen an Qualität und Kompetenz
ISBN978 0 580 94153 5
File Size1.798 MB

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