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
      • WRHA
    • 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
    • WRHA
  • 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 Z11135:15 (R2020)

    Codes & Standards - Purchase

    CSA Z11135:15 (R2020)

    Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices (Adopted ISO 11135:2014, second edition, 2014-07-15)
    SKU: 2424140 Published by CSA Group Publication Year 2015 Reaffirmed in 2020 100 pages

    Product Details

    • Preface/Scope
    • Editions

    CSA Preface


    This is the first edition of CAN/CSA-Z11135, Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 11135 (second edition, 2014-07-15).


    This Standard replaces CAN/CSA-Z11135-1-09, Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (adopted ISO 11135-1:2007), and CAN/CSA-Z11135-2-09, Sterilization of health care products — Ethylene oxide — Part 2: Guidance on the application of ISO 11135-1 (adopted ISO/TS 11135-2:2008), which have been revised and condensed into one Standard.


    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


    1.1 Inclusions


    This International Standard specifies requirements for the development, validation and routine control of an ethylene oxide sterilization process for medical devices in both the industrial and health care facility settings, and it acknowledges the similarities and differences between the two applications.


    NOTE 1 Among the similarities are the common need for quality systems, staff training, and proper safety measures. The major differences relate to the unique physical and organizational conditions in health care facilities, and to the initial condition of reusable medical devices being presented for sterilization.


    NOTE 2 Health care facilities differ from medical device manufacturers in the physical design of processing areas, in the equipment used, and in the availability of personnel with adequate levels of training and experience. The primary function of the health care facility is to provide patient care; medical device reprocessing is just one of a myriad of activities that are performed to support that function.


    NOTE 3 In terms of the initial condition of medical devices, medical device manufacturers generally sterilize large numbers of similar medical devices that have been produced from virgin material. Health care facilities, on the other hand, must handle and process both new medical devices and reusable medical devices of different descriptions and with varying levels of bioburden. They are therefore faced with the additional challenges of cleaning, evaluating, preparing and packaging a medical device prior to sterilization. In this International Standard, alternative approaches and guidance specific to health care facilities are identified as such.


    NOTE 4 EO gas and its mixtures are effective sterilants that are primarily used for heat- and/or moisture sensitive medical devices that cannot be moist heat sterilized.


    NOTE 5 Although the scope of this International Standard is limited to medical devices, it specifies requirements and provides guidance that can be applicable to other health care products.


    1.2 Exclusions


    1.2.1 This International Standard does not specify requirements for the development, validation and routine control of a process for inactivating the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.


    NOTE See ISO 22442-1, ISO 22442-2 and ISO 22442-3.


    1.2.2 This International Standard does not detail a specified requirement for designating a medical device as sterile.


    NOTE Attention is drawn to national or regional requirements for designating medical devices as sterile. See for example EN 556–1 or ANSI/AAMI ST67.


    1.2.3 This International Standard does not specify a quality management system for the control of all stages of production of medical devices.


    NOTE The effective implementation of defined and documented procedures is necessary for the development, validation and routine control of a sterilization process for medical devices. Such procedures are commonly considered to be elements of a quality management system. It is not a requirement of this International Standard to have a full quality management system during manufacture or reprocessing. The necessary elements are normatively referenced at appropriate places in the text (see, in particular, Clause 4). Attention is drawn to the standards for quality management systems (see ISO 13485) that control all stages of production or reprocessing of medical devices. National and/or regional regulations for the provision of medical devices might require the implementation of a full quality management system and the assessment of that system by a third party.


    1.2.4 This International Standard does not specify requirements for occupational safety associated with the design and operation of EO sterilization facilities.


    NOTE 1 For further information on safety, see examples in the Bibliography. National or regional regulations may also exist.


    NOTE 2 EO is toxic, flammable and explosive. Attention is drawn to the possible existence in some countries of regulations giving safety requirements for handling EO and for premises in which it is used.


    1.2.5 This International Standard does not cover sterilization by injecting EO or mixtures containing EO directly into packages or a flexible chamber.


    NOTE See ISO 14937 for these types of EO processes.


    1.2.6 This International Standard does not cover analytical methods for determining levels of residual EO and/or its reaction products.


    NOTE 1 For further information see ISO 10993-7.


    NOTE 2 Attention is drawn to the possible existence of national or regional regulations specifying limits for the level of EO residues present on or in medical devices.

    items 1 - of 3 result(s)
    View 20 | View 100

    CAN/CSA-Z11135-2-09 (R2014)

    CAN/CSA-Z11135-2-09 (R2014) - Sterilization of health care products - Ethylene oxide - Part 2: Guidance on the application of ISO 11135-1 (Adopted ISO/TS 11135-2:2008, first edition, 2008-08-01)

    Withdrawn

    CAN/CSA-Z11135-1-09 (R2014)

    CAN/CSA-Z11135-1-09 (R2014) - Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (Adopted ISO 11135-1:2007, first edition, 2007-05-01, with Canadian deviations)

    Withdrawn

    CAN/CSA-ISO 11135-98 (R2003)

    Medical Devices - Validation and Routine Control of Ethylene Oxide Sterilization (Adopted ISO 11135:1994, first edition)

    Withdrawn
    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 access
    Full-text search
    Create highlights and personal notes
    Newest editions added automatically
    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
    Toggle between your files and the full standard to maintain context
    Instantly preview cross referenced material within the book
    Export personal notes to Excel
    Transfer notes and highlights when updates are available
    Adobe Reader PDF and browser compatible for iOS and Android
    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
    © 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