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
    • CSA Group
    • Health Care and Well-being
    • Health Care
    • Medical Device Management
    • CSA ISO 11607-2:21

    Codes & Standards - Purchase

    CSA ISO 11607-2:21

    Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes (Adopted ISO 11607-2:2019, second edition, 2019-02)

    SKU: 2429226 Published by CSA Group Publication Year 2021 31 pages

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

    Product Details

    • Preface/Scope
    • Editions

    CSA Preface


    This is the second edition of CSA ISO 11607-2, Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes, which is an adoption without modification of the identically titled ISO (International Organization for Standardization) Standard 11607-2 (second edition, 2019-02). It supersedes the previous edition, published in 2016 as CAN/CSA-ISO 11607-2 (adopted ISO 11607-2:2006, including Amendment 1:2014).


    CSA Group acknowledges that the adoption of this Standard was made possible, in part, by the financial support of the governments of Alberta, British Columbia, Manitoba, New Brunswick, Newfoundland and Labrador, Northwest Territories, Nova Scotia, Nunavut, Ontario, Prince Edward Island, Quebec, Saskatchewan, and Yukon, as administered by the Canadian Agency for Drugs and Technologies in Health (CADTH).


    This Standard has been developed in compliance with Standards Council of Canada requirements for National Standards of Canada. It has been published as a National Standard of Canada by CSA Group.


    Scope


    This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.


    It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.


    It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.

    items 1 - of 1 result(s)
    View 20 | View 100

    CAN/CSA-ISO 11607-2:16

    Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes (Adopted ISO 11607-2:2006, first edition, 2006-04-15, including amendment 1:2014)

    Withdrawn
    EnglishFrench
    copyright imgRequest Copyright Permissions

    Buy

    Language

    Radio input
    Radio input

    Format

    Radio input
    Radio input
    • Free updates to the latest version
    • Access historical versions
    • Access all supported languages
    Learn More
    • 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