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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

standard by International Organization for Standardization , 12/01/2020

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Full Description

ISO 17822:2020 describes the particular clinical laboratory practice requirements to ensure the quality of detection, identification and quantification of microbial pathogens using nucleic acid amplification tests (NAAT).

It is intended for use by laboratories that develop, and/or implement and use, or perform NAAT for medical, research or health-related purposes. This document does not apply to the development of in vitro diagnostic (IVD) medical devices by manufacturers. However, it does include verification and validation of such devices and/or the corresponding processes when implemented and used by the laboratories.

 

Product Details

Edition:
1st
Published:
12/01/2020
Number of Pages:
46
File Size:
1 file , 2.8 MB
Note:
This product is unavailable in Ukraine, Russia, Belarus
 

Document History

  1. ISO 17822:2020

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    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


    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