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 Group logo, links to home
    • 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)
    • CSA Learning
    • Services
    Cart Icon0
    Login / Register
    English / USD

    Language

    en

    fr

    Currency

    CAD

    USD

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

    • 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)

    • 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)

    CSA Learning

    Services

    Login / Register
    English / USD

    Language

    en

    fr

    Currency

    CAD

    USD

    Wishlist Cart (
    )

    Search Section

      • Subscriptions
      • CSA
      • Electrical
      • Electrical Installation Safety
      • Installation Safety - Canadian Electrical Code Part I

      Codes & Standards - Subscribe

      CSA SPE-3000:19

      Model code for the field evaluation of medical electrical equipment (MEE) and medical electrical systems (MES)

      SKU: 2703820 Published by CSA Group Publication Year 2019

      Product Details

      • Preface/Scope
      • Items Included

      Preface


      This is the second edition of CSA SPE-3000, Model Code for the field evaluation of medical electrical equipment (MEE) and medical electrical systems (MES). It supersedes the previous edition, published in 2015 as Model code for the field evaluation of medical electrical equipment and systems, that was referenced by the Standards Council of Canada in its terms of accreditation for field evaluation bodies. However, at the time of publication, 4 specific types of medical equipment were excluded from SPE-3000. The second edition will include the following medical equipment that was previously excluded:


      a) cosmetic and hygiene equipment;


      b) X-ray equipment and systems;


      c) MRIs and CT scanners; and


      d) laser equipment


      Field evaluation of MEE and MES in accordance with this Model Code should be undertaken only by fully qualified and competent persons. These persons should have at least five years of experience in conducting field evaluation and field testing of electrical/electronic equipment, or three years of experience in testing and certification of medical electrical equipment and systems to Canadian standards or other equivalent nationally or internationally recognized standards.


      Because field evaluation of MEE and MES is conducted to the requirements of this Model Code, it is not equivalent to an evaluation in support of certification, which is conducted to the requirements of the applicable product standard. Consequently, equipment and products that are field evaluated and labelled cannot be claimed to be certified.


      Field evaluation of electrical equipment in accordance with the requirements of this Model Code is intended to be conducted by an inspection body accredited by Standards Council of Canada (SCC). Inspection body accreditation is the process of assessing and publicly recognizing the integrity, reliability, and technical competence of an organization’s inspection services. Accreditation of an organization’s inspection services by the SCC is a means of demonstrating that those services (within the scope of their formal accreditation) conform to an accepted set of requirements.


      This Model Code addresses the minimum requirements for MEE and MES as they pertain to safety. Where other authorities have jurisdiction, they must be consulted by the equipment owner or the owner’s agent as to conformance to specific legislation. This legislation may be federal, provincial, or municipal.


      This Model Code addresses the essential construction, marking, and test requirements that MEE and MES must meet before they can be labelled. It allows for the evaluation of MEE and MES, with the objective of minimizing the risk of degrading the safety of the equipment or system through the procedures used in the field evaluation.


      The requirements contained in this Model Code are based on the applicable requirements of SPE-1000 and selected requirements of CAN/CSA-C22.2 No. 60601-1.


      Where the required tests involve procedures deemed to present a hazard to the safety of the particular equipment, such tests may be carried out on a separate representative sample supplied for the sole purpose of testing. Alternatively, other means may be taken to determine conformance, such as the evaluation of relevant test data presented in support of an application for field evaluation.


      Due to alternative evaluation criteria contained in IEC 60601-1, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance, Edition 3 and Edition 3.1, MEE and MES constructed to that standard may not pass certain tests within this Model Code. The requirements of this Model Code have been accepted by the authorities having jurisdiction (AHJ). It is within the purview of the AHJ in whose jurisdiction the Model Code is applied to add technical or administrative stipulations to or deviations from the Model Code as deemed necessary.


      Scope


      1.1

      This Model Code applies to the safety of medical electrical equipment (MEE) and medical electrical systems (MES) as it pertains to protection from electrical shock, and fire and mechanical hazards. It provides construction, marking, and test requirements for the field evaluation of MEE and MES by a field evaluation body accredited by the SCC and/or recognized by the regulatory authority.


      Equipment and systems may be evaluated at a client's facilities or at other specified locations, including the location of equipment installation.


      If a clause or subclause is specifically intended to be applicable to MEE only, or to MES only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to MEE and MES, as relevant.


      Hazards inherent in the intended physiological function of MEE and MES within the scope of this Model Code are not covered in this Model Code.


      1.2

      Field-evaluated equipment found to be in conformity with the requirements of this Model Code and bearing the appropriate label of the field evaluation body is considered to be acceptable to the authority having jurisdiction (AHJ).


      1.3

      Notwithstanding of Clauses 1.1 and 1.2, field evaluation is not intended to serve as a substitute for certification.


      1.4

      The following are scenarios in which this Model Code applies:


      a) custom-built equipment for special applications;


      b) equipment manufactured on a non-repetitive basis;


      c) equipment sold in quantities of not more than 500 on a national basis, per model, per year, per field evaluation body;


      d) equipment not obtainable as certified under a regular certification program;


      e) equipment already installed or ready for use on site and awaiting acceptance by the AHJ;


      f) complete systems that are all available for examination and testing during the evaluation process; and


      g) other equipment as determined by the AHJ.


      Note: Where it is unclear or there is uncertainty as to whether the equipment is to be field evaluated under the classifications of this Clause, the AHJ should be consulted for clarification.


      1.5

      This Model Code applies where the requirements are supplemented by requirements of particular equipment Standards, where referenced, and the installation requirements of the Canadian Electrical Code, Part I, and the CAN/CSA-C22.2 No. 60601 series of Standards as applicable.


      1.6

      This Model Code is not intended to apply to the re-evaluation of equipment that has been rejected due to the results of a previous evaluation conducted by a certification organization through any other existing certification service.


      1.7

      In this Model Code, shall is used to express a requirement, i.e., a provision that the user is obliged to satisfy in order to comply with this Model Code; should is used to express a recommendation or that which is advised but not required; and may is used to express an option or that which is permissible within the limits of this Model Code.


      Notes accompanying clauses do not include requirements or alternative requirements; the purpose of a note accompanying a clause is to separate from the text explanatory or informative material.


      Notes to tables and figures are considered part of the table or figure and may be written as requirements.


      Annexes are designated normative (mandatory) or informative (non-mandatory) to define their application.


      1.8

      In accordance with Clause 1.7, this Model Code has been written in mandatory language to facilitate its adoption where users of the Model Code or regulatory authority wish to do so.

      Download a list of included items
      items 1 - of 4 result(s)
      View 20 | View 100

      CSA SPE-3000:19

      Model code for the field evaluation of medical electrical equipment (MEE) and medical electrical systems (MES)

      Active
      English

      CSA SPE-3000:F19

      Code modèle pour l’évaluation à pied d’oeuvre des appareils électromédicaux (AÉM) et des systèmes électromédicaux (SÉM)

      Active
      French

      SPE-3000-15

      Model code for the field evaluation of medical electrical equipment and systems

      Withdrawn
      English

      SPE-3000-F15

      Code modèle pour l’évaluation à pied d’oeuvre de l’appareillage et des systèmes électromédicaux

      Withdrawn
      French
      copyright imgRequest Copyright Permissions

      Subscribe

      Annual subscription keeps you up-to-date with the latest editions of standards and includes all supported languages and archive versions. 

      * Price is for up to 10 users. Select the number of users required on the cart page. Subscription must include a minimum of 10 standards or a collection to proceed to checkout.

      Includes annual access to:

             • Newest and previous editions in PDF format 
             • Revisions, updates and amendments 
             • All supported languages 

      Learn More

      PDF

      English, French

      Go to additional format options
      • 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