Skip to content
CSA Store
  • CSA Group
  • CSA OnDemandâ„¢
  • 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 OnDemandâ„¢
  • 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
    • CSA Group
    • Health Care and Well-being
    • Health Care
    • Medical Device Management
    • CAN/CSA-ISO 14971-07 (R2017)

    Codes & Standards - Purchase

    CAN/CSA-ISO 14971-07 (R2017)

    Medical Devices - Application of Risk Management to Medical Devices (Adopted ISO 14971:2007, second edition, 2007-03-01)
    SKU: 2418541 Published by CSA Group Publication Year 2007 Reaffirmed in 2017 100 pages Withdrawn

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

    Product Details

    • Preface/Scope

    CSA Preface


    This is the second edition of CAN/CSA-ISO 14971, Medical devices - Application of risk management to medical devices, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 14971 (second edition, 2007-03-01). This Standard supersedes the previous edition published in 2001 as CAN/CSA-ISO 14971 (adopted ISO 14971:2000) and CSA Amendment 1:2003 to CAN/CSA-ISO 14971:01 (adopted ISO Amendment 1:2003).


    Scope


    This International Standard specifies a process for a manufacturer to identify the hazards associated with medical devices, including in vitro diagnostic (IVD) medical devices, to estimate and evaluate the associated risks, to control these risks, and to monitor the effectiveness of the controls.


    The requirements of this International Standard are applicable to all stages of the life-cycle of a medical device.


    This International Standard does not apply to clinical decision making.


    This International Standard does not specify acceptable risk levels.


    This International Standard does not require that the manufacturer have a quality management system in place. However, risk management can be an integral part of a quality management system.

    copyright imgRequest Copyright Permissions

    Buy

    Quantity
    -
    +
    • 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