ISO/NP 25724

In vitro diagnostic medical devices — Open-platform PCR examinations for the detection of Mycobacterium tuberculosis and mutations associated with drug resistance-- Requirements for design, development and manufacture

Scope

This document specifies requirements and gives recommendations for the design and development of in vitro diagnostic (IVD) medical device workflows and manufacturing of associated products for open platform PCR examinations for the detection of Mycobacterium tuberculosis nucleic acids and mutations associated with drug resistance in pulmonary and extrapulmonary specimens. Workflows cover relevant pre-examination, examination and post-examination steps.
This document is applicable to developers and manufacturers of IVD products.