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ISO/TS 17822-1:2014 [ Withdrawn ]

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

standard by International Organization for Standardization (Technical Standard) , 12/15/2014

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Full Description

ISO/TS 17822-1:2014 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.

 

Product Details

Published:
12/15/2014
Number of Pages:
30
File Size:
1 file , 410 KB
Same As:
BS PD ISO/TS 17822-1:2014
Note:
This product is unavailable in Russia, Ukraine, Belarus
 

Document History

  1. ISO 17822:2020


    In vitro diagnostic test systems - Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens - Laboratory quality practice guideLaboratory quality practice guide

    • Most Recent

  2. ISO/TS 17822-1:2014

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    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

    • Historical Version