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“ISO 15223:2025 Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements – Amendment 1: Addition of defined term for authorized representative and modified EC REP symbol to not be country or region specific” has been added to your cart. View cart
ISO 17822:2020
ISO 17822:2020 In vitro diagnostic test systems – Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens – Laboratory quality practice guide
CDN $312.00
Description
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
1
Published Date
2020-12-01
Status
PUBLISHED
Pages
39
Language
English
Format
Secure PDF
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Abstract
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.
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