DANSK DS/ISO 17822 PDF

DANSK DS/ISO 17822 PDF

Name:
DANSK DS/ISO 17822 PDF

Published Date:
12/07/2020

Status:
[ Active ]

Description:

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

Publisher:
Dansk Standard

Document status:
Active

Format:
Electronic (PDF)

Delivery time:
10 minutes

Delivery time (for Russian version):
200 business days

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This document 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.


Edition : 20
File Size : 1 file , 2.8 MB
Number of Pages : 48
Product Code(s) : DS-041, DS-041
Published : 12/07/2020

History


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