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

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
    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

        • Why choose subscriptions?
        • About CSA Advantage™
        • About CSA OnDemand™
        • CSA OnDemand™ 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

      • Why choose subscriptions?
      • About CSA Advantage™
      • About CSA OnDemand™
      • CSA OnDemand™ 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
      • Sterilization And Disinfection
      • Sterilization And Disinfection In General
      • ISO 14160:2020

      Codes & Standards - Purchase

      ISO 14160:2020

      Sterilization of health care products — Liquid chemical sterilizing agents for single-use medical devices utilizing animal tissues and their derivatives — Requirements for characterization, development, validation and routine control of a sterilization process for medical devices
      SKU: iso_073159_167402 Published by ISO Publication Year 2020 3 Edition 37 pages

      Product Details

      • Overview
      This document specifies requirements for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin.
      This document covers the control of risks arising from contamination with bacteria and fungi by application of a liquid chemical sterilization process. Risks associated with other microorganisms can be assessed using other methods (see NOTE 1).
      This document is not applicable to material of human origin.
      This document does not describe methods for the validation of the inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (see NOTE 2 and NOTE 3).
      This document does not describe methods for validation of the inactivation or elimination of protozoa and parasites.
      The requirements for validation and routine control described in this document are only applicable to the defined sterilization process of a medical device, which is performed after the manufacturing process, and do not take account of the lethal effects of other bioburden reduction steps (see NOTE 4).
      This document does not specify tests to establish the effects of any chosen sterilization process upon the fitness for use of the medical device (see NOTE 5).
      This document does not cover the level of residual sterilizing agent within medical devices (see NOTE 6).
      Guidance for the characterization of a liquid chemical sterilizing agent and for the development, validation, process control and monitoring of sterilization by liquid chemical sterilizing agents of single-use medical devices comprising, in whole or in part, materials of animal origin is provided in informative Annex A.
      NOTE 1 The prior application of risk management principles to medical devices utilizing animal tissues, as described in ISO 22442-1 is important. ISO 18362 provides information on control of microbial risks during processing of cell-based health-care products.
      NOTE 2 Liquid chemical sterilizing agents traditionally employed to sterilize animal tissues in medical devices might not be effective in inactivating the causative agents of TSE such as bovine spongiform encephalopathy (BSE), or scrapie. Satisfactory validation in accordance with this document does not necessarily demonstrate inactivation of infective agents of this type. Risk controls related to sourcing, collection and handling of animal materials are described in ISO 22442-2.
      NOTE 3 The validation of the inactivation, elimination, or elimination and inactivation of viruses and TSE agents is described in ISO 22442-3.
      NOTE 4 Manufacturing processes for medical devices containing animal tissues frequently include exposure to chemical agents which can significantly reduce the bioburden on the medical device. Following the manufacturing process, a medical device is exposed to a specified sterilization process.
      NOTE 5 Such testing is a crucial part of the design and development of a medical device.
      NOTE 6 ISO 10993-17 specifies a method to establish allowable limits for residues of sterilizing agents.
      NOTE 7 Standards for quality management systems (see ISO 13485) can be used in the control of all stages of manufacture including the sterilization process.

      Buy

      Language

      Radio input
      Radio input

      Format

      Radio input
      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.

      Select the subscription format that is right for you. Table with 13 rows and 3 columns, identifies features available and not available for the two different subscription formats - CSA Advantage TM and CSA OnDemand TM
      Features CSA AdvantageTM CSA OnDemandTM
      Offline access CSA AdvantageTM. feature available. Offline access CSA OnDemandTM. feature available. Offline access
      Full-text search CSA AdvantageTM. feature available. Full-text search CSA OnDemandTM. feature available. Full-text search
      Create highlights and personal notes CSA AdvantageTM. feature available. Create highlights and personal notes CSA OnDemandTM. feature available. Create highlights and personal notes
      Newest editions added automatically CSA AdvantageTM. feature available. Newest editions added automatically CSA OnDemandTM. feature available. Newest editions added automatically
      Includes all supported languages and archive versions CSA AdvantageTM. feature not available. Includes all supported languages and archive versions CSA OnDemandTM. feature available. Includes all supported languages and archive versions
      My Files - create customized files by adding multiple clauses, tables or figures from the standard into your own personal File for quick reference CSA AdvantageTM. feature available. My Files - create customized files by adding multiple clauses, tables or figures from the standard into your own personal File for quick reference CSA OnDemandTM. feature not available. My Files - create customized files by adding multiple clauses, tables or figures from the standard into your own personal File for quick reference
      Toggle between your files and the full standard to maintain context CSA AdvantageTM. feature available. Toggle between your files and the full standard to maintain context CSA OnDemandTM. feature not available. Toggle between your files and the full standard to maintain context
      Instantly preview cross referenced material within the book CSA AdvantageTM. feature available. Instantly preview cross referenced material within the book CSA OnDemandTM. feature not available. Instantly preview cross referenced material within the book
      Export personal notes to Excel CSA AdvantageTM. feature available. Export personal notes to Excel CSA OnDemandTM. feature not available. Export personal notes to Excel
      Transfer notes and highlights when updates are available CSA AdvantageTM. feature available. Transfer notes and highlights when updates are available CSA OnDemandTM. feature not available. Transfer notes and highlights when updates are available
      Adobe Reader PDF and browser compatible for iOS and Android CSA AdvantageTM. feature not available. Adobe Reader PDF and browser compatible for iOS and Android CSA OnDemandTM. feature available. Adobe Reader PDF and browser compatible for iOS and Android
      Web, Android, iOS Compatible CSA AdvantageTM. feature available. Web, Android, iOS Compatible CSA OnDemandTM. feature not available. Web, Android, iOS Compatible

      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
      © 2023 Canadian Standards Association. All rights reserved

      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