Laboratorní medicína, klinická patologie a biologická bezpečnost

Komise : CEN/TC 140 (In vitro diagnostic medical devices)
Původce: CEN
K připomínkám do: 29.03.2019
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This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks.

The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record and other technical and management processes described in ISO15189.

This document does not specify acceptable levels of risk.

This document does not apply to risks from post-examination clinical decisions made by healthcare providers.

This document does not apply to the management of risks affecting the medical laboratory enterprise that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.

NOTE   International, national, or regional regulations or requirements may also apply to specific topics covered in this international standard