ISO/TS 22583:2019 PDF

Name: ISO/TS 22583:2019 — Guidance for supervisors and operators of point-of-care testing (POCT) devices
SKU: ISO/TS 22583:2019
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Guidance for supervisors and operators of point-of-care testing (POCT) devices

Название (английский):

ISO/TS 22583:2019

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

Статус документа:: Отменён
Формат:: Электронный (PDF)
Количество страниц:: 35
Дата публикации:: 18 ноября 2019 г.
Издание:: ISO TS 22583 edition 1 version 1
ICS:: 03.100.30

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Описание (английский):

This document gives guidance for supervisors and operators of point-of-care testing (POCT) services where POCT is performed without medical laboratory training, supervision or support. It includes the key components that should be considered to provide safe and reliable POCT results. Self-testing is excluded from this document.

Abstract

Похожие стандарты

Упомянутые в описании и другие стандарты ISO

Overview

ISO/TS 22583:2019 - Guidance for supervisors and operators of point-of-care testing (POCT) devices - is a Technical Specification from ISO that provides practical guidance where POCT is performed without medical laboratory training, supervision or support. It focuses on the key components needed to deliver safe, reliable POCT results and explicitly excludes self‑testing. The document is written in accessible language and is intended to support appropriate test selection, operator skill requirements, quality arrangements and result interpretation.

Key topics and requirements

The specification addresses the full POCT lifecycle and organizational controls, including:

Personnel

Roles and responsibilities for supervisors and operators
Training and competence requirements (Annex A)

POCT equipment selection

Considerations for choosing suitable devices and tests (Annex B)

Process management

Pre‑testing (planning, environment, consumables, patient consent and identity verification, sample collection)
Testing (internal quality control, external quality assessment, performing tests, problem resolution) - Annex D covers IQC and EQA
Post‑testing (result interpretation, reporting, recipient management, disposal and cleaning)

Quality oversight

Internal quality control, external quality assessment and external audits of POCT services

Information management

Confidentiality, security and recordkeeping considerations

Documentation and records

Document control, storage, corrections and retention (Annex C)

Health and safety

Infection prevention and biosafety, use of sharps, personal protective equipment and waste disposal (Annex E)

Practical applications

ISO/TS 22583:2019 is intended to ensure that POCT performed outside traditional laboratories:

Produces reliable, clinically meaningful results

Reduces patient safety risks from incorrect testing or interpretation

Supports decision-making in time‑critical or remote settings

Common use cases:

Diabetes management (glucose monitoring)

Anticoagulation and clotting tests

Infectious disease screening in outreach clinics

Pregnancy testing, cardiac marker screening, hemoglobin testing

Drug testing in occupational, forensic or sports settings

Who should use this standard

POCT supervisors setting up or overseeing non‑laboratory testing programs

Operators and trainers working with POCT devices outside clinical laboratories

Healthcare managers in hospitals, primary care, pharmacies, long‑term care, emergency services, remote clinics and public safety organizations

Manufacturers and purchasers of POCT devices seeking guidance for safe deployment

Related standards

ISO 15189 - Medical laboratories - Requirements for quality and competence

ISO 22870 - Point‑of‑care testing (POCT) - Requirements for quality and competence

ISO/TS 22583:2019 complements these standards by focusing on practical guidance for non‑laboratory supervisors and operators to maintain quality, safety and traceability in POCT services.

ISO/TS 22583:2019 PDF

Abstract

Похожие стандарты

Overview

Key topics and requirements

Practical applications

Who should use this standard

Related standards

Технические детали

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ISO 22870:2006

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