ISO 5798:2022
ISO 5798:2022 In vitro diagnostic test systems – Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) by nucleic acid amplification methods
CDN $312.00
Description
This document provides requirements and recommendations for the design, development, verification, validation and implementation of analytical tests for detecting the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using nucleic acid amplification. It addresses pre-examination, examination and post-examination process steps for human specimens.
This document is applicable to medical laboratories. It is also intended to be used by in vitro diagnostic developers and manufacturers, as well as by institutions and organizations supporting SARS-CoV-2 research and diagnostics.
This document does not apply to environmental samples.
Edition
1
Published Date
2022-04-19
Status
PUBLISHED
Pages
44
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 provides requirements and recommendations for the design, development, verification, validation and implementation of analytical tests for detecting the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) using nucleic acid amplification. It addresses pre-examination, examination and post-examination process steps for human specimens.
This document is applicable to medical laboratories. It is also intended to be used by in vitro diagnostic developers and manufacturers, as well as by institutions and organizations supporting SARS-CoV-2 research and diagnostics.
This document does not apply to environmental samples.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-
ISO 80004:2020 Nanotechnologies – Vocabulary – Part 8: Nanomanufacturing processes
CDN $76.00 Add to cart -
ISO 22553:2019 Paints and varnishes – Electro-deposition coatings – Part 1: Vocabulary
CDN $76.00 Add to cart -
ISO 80004:2020 Nanotechnologies – Vocabulary – Part 3: Carbon nano-objects
CDN $76.00 Add to cart -
ISO 2574:1994 Aircraft – Electrical cables – Identification marking
CDN $115.00 Add to cart
