ISO 17822:2020
Current
The latest, up-to-date edition.
In vitro diagnostic test systems Nucleic acid amplification-based examination procedures for detection and identification of microbial pathogens Laboratory quality practice guide
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
English
01-12-2020
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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.
| DocumentType |
Standard
|
| Pages |
39
|
| ProductNote |
THIS STANDARD ALSO REFERS TO :CLSI, MM03, CLSI MM06, JCCLS MM5-A1, JCGM 200, ISO 11843, CLSI MM07-A2, CLSI MM17-A2
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| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| IS 18131 : 2023 | Identical |
| UNI ISO 17822:2023 | Identical |
| BS ISO 17822:2020 | Identical |
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