Ämnesområden

Ämnesområden:
Kommittébeteckning: SIS/TK 331 (Medicinsk diagnostik)
Källa: CEN
Svarsdatum: den 8 mar 2024
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This document specifies requirements for reference measurement procedures for measurands used in laboratory medicine.

Ämnesområden:
Kommittébeteckning: SIS/TK 331 (Medicinsk diagnostik)
Källa: CEN
Svarsdatum: den 8 mar 2024
Se merSe mindre
 

This standard specifies requirements for producers of CRMs of higher metrological order and the content of their supporting documentation that comply with the requirements of ISO 17511 and the calibration hierarchies described therein. It is applicable to CRMs intended for use as either primary reference materials, secondary calibrators or international conventional calibrators within calibration hierarchies appropriate for measurands used in laboratory medicine, or for applications as trueness controls. Requirements for determining the certified value of a CRM, including evaluation and reporting of the assigned uncertainty, are specified.

Ämnesområden:
Kommittébeteckning: SIS/TK 331 (Medicinsk diagnostik)
Källa: CEN
Svarsdatum: den 8 mar 2024
Se merSe mindre
 

The proposed standard document specifies requirements for ensuring quality, safety and performance of laboratory-developed tests (LDT). It outlines the general principles and assessment criteria by which LDT shall be designed, developed, manufactured, validated and monitored for internal use by medical laboratories. While the proposed standard follows a current best practice and state-of-the art approach, it does not provide specific details on how to achieve these requirements within certain disciplines of medical laboratory testing. This document does not cover requirements for examination procedures developed by research or academic laboratories developing and using testing systems for non-in-vitro-diagnostic purposes. However, the concepts presented in this document may also be useful for these institutions. The proposed standard does not apply to the design, development and industrial production of commercially used in vitro diagnostic medical devices.