Draft
Technical Specification
ISO/DTS 7122
Health informatics — Guidelines for exchanging data generated by portable polymerase chain reaction (PCR) devices for point-of-care testing (POCT) between screening centre and clinical laboratory
Reference number
ISO/DTS 7122
Edition 1
Draft Technical Specification
ISO/DTS 7122
82636
Indisponible en français
Projet au stade approbation.

Résumé

This document identifies use cases related to the exchange of information between new small-sized point of care testing devices that enable real time PCR testing for diagnosis of infectious diseases, and clinical laboratories. This document is applicable to use cases of small-sized real time PCR devices, including those that: a) general test; b) lack of patient information; c) cancel and rerun test; d) on-site Quality Control (QC) process. This document also provides guidelines on how to represent and exchange the result of real time PCR testing devices in a POCT environment applicable to the use cases described above. This document is not intended to provide guidelines relating to traditional diagnostic testing results within a clinical laboratory.

Informations générales

  •  : Projet
    : Epreuve envoyée au secrétariat ou mise au vote du FDIS: 8 semaines [50.20]
  •  : 1
  • ISO/TC 215
    35.240.80 
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