ISO 17822 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.
Note: ISO 17822 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.
ISO 17822 on microbial pathogens is relevant to:
Nucleic acid amplification-based tests (NAATs) are now commonly used in in-vitro diagnostic (IVD) tools in laboratory medicine for the detection, identification and quantification of microbial pathogens. The NAAT result is influenced by all steps of the entire diagnostic workflow (i.e. pre-examination, examination, post-examination). Therefore, ISO 17822 considers all critical aspects of the entire diagnostic workflow when designing, developing and implementing and using a specific microbial pathogen NAAT examination.
ISO 17822 covers the implementation of commercially available IVD(s) into the medical laboratory routine use as well as the design, development and implementation of laboratory-developed tests (LDT).
ISO 17822 will address the additional specific considerations, requirements and recommendations for the detection of microbial pathogens with sampling, nucleic acid extraction, genetic heterogeneity and the laboratory containment category which is required.
Detection of of microbial pathogens is very important as it provides speed, simplicity, and accuracy in the detection of infections and pathogens, ISO 17822 enables you to do the same with clinical laboratory practice requirements. This will ensure safety for you and your clients.
What’s changed since the last update?
BS ISO 17822:2020 supersedes PD ISO/TS 17822‑1:2014, which is withdrawn and has its clause 4 updated and merged from ISO/TS 17822-1:2014.
ISO 17822:2020