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ISO TS 17822-1

In vitro diagnostic test systems - Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens - Part 1: General requirements, terms and definitions

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Organization: ISO
Publication Date: 15 December 2014
Status: active
Page Count: 30
ICS Code (Testing (Vocabularies)): 01.040.19
ICS Code (Laboratory medicine in general): 11.100.01
scope:

This Technical Specification is intended for

- IVD medical device manufacturers, medical laboratories, and research and development laboratories that develop nucleic acid-based qualitative in vitro diagnostic examination procedures for the detection and identification of microbial pathogens in human specimens, and

- medical laboratories that perform nucleic acid-based in vitro diagnostic examinations for the detection and identification of microbial pathogens in human specimens.

This part of ISO/TS 17822 does not apply to

- nucleic acid-based examinations that are not intended for in vitro diagnostic use, or

- quantitative nucleic acid-based in vitro diagnostic examination procedures.

Document History

ISO TS 17822-1
December 15, 2014
In vitro diagnostic test systems - Qualitative nucleic acid-based in vitro examination procedures for detection and identification of microbial pathogens - Part 1: General requirements, terms and definitions
This Technical Specification is intended for — IVD medical device manufacturers, medical laboratories, and research and development laboratories that develop nucleic acid-based qualitative in vitro...

References

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