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 $349.00
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
Secure – PDF details
- Save your file locally or view it via a web viewer
- Viewing permissions are restricted exclusively to the purchaser
- Device limits - 3
- Printing – Enabled only to print (1) copy
See more about our Environmental Commitment
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.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-
ISO 4125:1991 Dry fruits and dried fruits – Definitions and nomenclature
CDN $85.00 Add to cart -
ISO 20537:2025 Footwear – Identification of defects during visual inspection – Vocabulary
CDN $307.00 Add to cart -
ISO 1991:1982 Vegetables – Nomenclature – First list
CDN $130.00 Add to cart -
ISO 20712:2024 Water safety signs and beach safety flags – Part 3: Guidance for use
CDN $261.00 Add to cart
