Skip to content
CSA Store
  • CSA Group
  • CSA OnDemand™
  • CSA Communities
  • Contact Us
  • Catalogue
    • Browse By Subject Area

      • Electrical
      • Fuels & Transportation
      • Petroleum & Natural Gas
      • Environment & Natural Resources
      • Construction & Infrastructure
      • Mechanical & Industrial Equipment
      • Nuclear
      • Health Care and Well-being
      • Worker & Public Safety
      • Management Systems
    • Browse By Publisher

      • ASME
      • ASTM
      • CSA Group
      • ESA
      • IEC
      • ISO
      • NRC
      • ORNAC
      • TSSA
    • ICS Catalogue

      • Browse by International Classification of Standards (ICS Codes)
  • Subscription
    • Browse By Subject Area

      • Electrical
      • Fuels & Transportation
      • Petroleum & Natural Gas
      • Environment & Natural Resources
      • Construction & Infrastructure
      • Mechanical & Industrial Equipment
      • Nuclear
      • Health Care and Well-being
      • Worker & Public Safety
      • Management Systems
    • CSA Subscriptions

      • Overview
      • Collections
    • ICS Catalogue

      • Browse by International Classification of Standards (ICS Codes)
  • Services
Cart Icon0
×
Login / Register
English / CAD

Language

en

fr

Currency

CAD

USD

  • CSA Group
  • CSA OnDemand™
  • CSA Communities
  • Contact Us
Wishlist

Catalogue

  • Browse By Subject Area

    • Electrical
    • Fuels & Transportation
    • Petroleum & Natural Gas
    • Environment & Natural Resources
    • Construction & Infrastructure
    • Mechanical & Industrial Equipment
    • Nuclear
    • Health Care and Well-being
    • Worker & Public Safety
    • Management Systems
  • Browse By Publisher

    • ASME
    • ASTM
    • CSA Group
    • ESA
    • IEC
    • ISO
    • NRC
    • ORNAC
    • TSSA
  • ICS Catalogue

    • Browse by International Classification of Standards (ICS Codes)

Subscription

  • Browse By Subject Area

    • Electrical
    • Fuels & Transportation
    • Petroleum & Natural Gas
    • Environment & Natural Resources
    • Construction & Infrastructure
    • Mechanical & Industrial Equipment
    • Nuclear
    • Health Care and Well-being
    • Worker & Public Safety
    • Management Systems
  • CSA Subscriptions

    • Overview
    • Collections
  • ICS Catalogue

    • Browse by International Classification of Standards (ICS Codes)

Services

Menu toggle Icon
Login / Register
English / CAD

Language

en

fr

Currency

CAD

USD

Wishlist Cart (
)

Search Section

    • Home
    • ICS
    • Health Care Technology
    • Laboratory Medicine
    • In Vitro Diagnostic Test Systems
    • ISO 21474-1:2020

    Codes & Standards - Purchase

    ISO 21474-1:2020

    In vitro diagnostic medical devices — Multiplex molecular testing for nucleic acids — Part 1: Terminology and general requirements for nucleic acid quality evaluation
    SKU: iso_070960_170415 Published by ISO Publication Year 2020 1 Edition 22 pages

    Product Details

    • Overview
    This document provides the terms and general requirements for the evaluation of the quality of nucleic acids as the analytes for multiplex molecular tests, which simultaneously identify two or more nucleic acid target sequences of interest. This document is applicable to all multiplex molecular methods used for examination using in vitro diagnostic (IVD) medical devices and laboratory developed tests (LDTs). It provides information for both qualitative and quantitative detection of nucleic acid target sequences.
    This document is intended as guidance for multiplex molecular assays that detect and/or quantify human nucleic acid target sequences or microbial pathogen nucleic acid target sequences from human clinical specimens. This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. This document is not applicable to metagenomics.
    NOTE An examination procedure developed for a laboratory's own use is often referred to as a laboratory developed test, LDT, or in-house test.

    Buy

    Language

    Radio input

    Format

    Radio input
    • FAQs
    • Contact Us
    • Email Product

    GST REG No R119441681
    QST REG No R1006017360

    Compare Formats

    Determine the subscription format that is right for you.

    Features CSA AdvantageTM CSA OnDemandTM
    Offline accessSelectedSelected
    Full-text searchSelectedSelected
    Create highlights and personal notesSelectedSelected
    Newest editions added automaticallySelectedSelected
    Includes all supported languages and archive versionsSelected
    My Files - create customized files by adding multiple clauses, tables or figures from the standard into your own personal File for quick referenceSelected
    Toggle between your files and the full standard to maintain contextSelected
    Instantly preview cross referenced material within the bookSelected
    Export personal notes to ExcelSelected
    Transfer notes and highlights when updates are availableSelected
    Adobe Reader PDF and browser compatible for iOS and AndroidSelected
    Web, Android, iOS CompatibleSelected

    Follow Us On Social Media

    Get Our Newsletter

    Get CSA Newsletter

    • About CSA Store
    • Subscription
    • Services
    • Catalogue
    • FAQ
    • Return Policy
    • FULFILLMENT DETAILS
    • EBOOK SUPPORT
    • Product Updates
    • Contact Us
    • CSA GROUP
    • CSA COMMUNITIES
    • CSA Update Service
    • About CSA Store
    • Subscription
    • Services
    • Catalogue
    • FAQ
    • Return Policy
    • FULFILLMENT DETAILS
    • EBOOK SUPPORT
    • Product Updates
    • Contact Us
    • CSA GROUP
    • CSA COMMUNITIES
    • CSA Update Service

    • General Terms and Conditions
    • Privacy Policy
    • Accessibility
    © 2022 Canadian Standards Association. All rights reserved
    logo close
    Privacy Preference Centre

    Please manage your cookie choices by switching the consent toggles on or off under the Purposes below.

    You may change your preference at any time as described in our Cookie Policy

    • Cookie Settings
    • List of Cookies
    close
      Cookies on CSA Group

      We use Cookies to create a secure and effective website experience for our customers. For more information about Cookies and how you can disable Cookies, visit our privacy policy page. Learn More

      Free Login/Registration Required

      View Access for this document is only available for viewers in Canada.

      A free user account is required to view this document.

      Login or Register