CSA SPE-3000:19

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

REVISED AUGUST 2020

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  Revision History

  CSA SPE-3000:19, Model Code for the field evaluation of medical electrical equipment (MEE) and medical electrical systems (MES)

  
  

  Errata — August 2020	Revision symbol (in margin)
  Clause 5.22	∆

  
  

  Standards Update Service

  CSA SPE-3000:19

  April 2019

  
  

  Title: Model Code for the field evaluation of medical electrical equipment (MEE) and medical electrical systems (MES)

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CSA SPE-3000:19

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

®A trademark of the Canadian Standards Association, operating as “CSA Group”

Published in April 2019 by CSA Group

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ISBN 978-1-4883-1650-0

© 2019 Canadian Standards Association

All rights reserved. No part of this publication may be reproduced in any form whatsoever without the prior permission of the publisher.

CSA SPE-3000:19

Model Code for the field evaluation of medical electrical equipment

(MEE) and medical electrical systems (MES)

Contents

Canadian Advisory Council on Electrical Safety 3

CACES Subcommittee on SPE-3000 5

Preface 7

0 Introduction 9

1. Scope 9

   
   

2. Reference publications 10

   
   

3. Definitions 12

   
   

4. General requirements and construction 19

   1. General requirements 19

      1. Compliance 19

      2. Safety and protection 20

      3. Materials 24

      4. Current-carrying parts 24

      5. Electrical insulation 25

      6. Classification of applied parts 25

   2. Construction 25

      1. Electrical components 25

      2. Enclosures 30

      3. Openings in enclosures 31

      4. Mechanical assembly 33

      5. Stability 34

      6. Interlocks 34

      7. Cord-connected equipment 35

      8. Permanently connected equipment 37

      9. Supply circuit disconnecting means 38

      10. Bonding 39

      11. Double insulation 40

      12. Isolation from the supply mains 40

      13. Interconnections 41

      14. Bushings 42

      15. Internal wiring 42

      16. Overcurrent, overload, and overtemperature protection devices 43

      17. Fuses and fuseholders 44

      18. Motor controls 45

      19. Equipment containing batteries 45

      20. Multivoltage equipment 46

      21. Spacings 46

      22. Accessible circuits 47

      23. Capacitors 48

      24. Suppressors 49

          
          

          April 2019 © 2019 Canadian Standards Association 1

          CSA SPE-3000:19

          Model Code for the field evaluation of medical electrical equipment

          (MEE) and medical electrical systems (MES)

          
          

      25. Heaters and heating elements 49

      26. Thermal insulation 50

      27. Backflow prevention 50

      28. Refrigerant-containing parts 51

      29. Water-heating tanks 51

      30. Protection of water heaters 51

      31. Direct plug-in equipment 52

      32. Installed equipment 52

          
          

5. Marking 52

   
   

6. Tests 59

   1. Cautions regarding testing of MEE 59

   2. Standard tests 59

      1. Dielectric voltage withstand 59

      2. Flame test 60

      3. Strain relief 61

      4. Leakage current (100%) 61

   3. Other tests 62

      1. General 62

      2. Input rating 62

      3. Temperature 62

      4. Abnormal tests 63

      5. Test for stability 63

      6. Submersible equipment 64

      7. Supporting device test 64

      8. Impact 64

      9. Starting 64

      10. Measurement of insulation resistance 65

          
          

7. Requirements for X-ray, magnetic resonance imaging, and computerized tomography scanning equipment 65

   1. General 65

   2. Label 65

   3. Breaker and disconnecting means 66

   4. High-voltage cables 66

      
      

8. Requirements for lasers and devices incorporating lasers 66

Annex A (informative) — Essential requirements of particular CSA Canadian Electrical Code, Part II standards (See Clause 4.1.1.4.) 83

Annex B (normative) — Field evaluation/special inspection labels 89

April 2019 © 2019 Canadian Standards Association 2

CSA SPE-3000:19

Model Code for the field evaluation of medical electrical equipment

(MEE) and medical electrical systems (MES)

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:

1. cosmetic and hygiene equipment;

2. X-ray equipment and systems;

3. MRIs and CT scanners; and

4. 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.

   
   

   April 2019 © 2019 Canadian Standards Association 7

   CSA SPE-3000:19

   Model Code for the field evaluation of medical electrical equipment

   (MEE) and medical electrical systems (MES)

   
   

   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.

   
   

   This Model Code was developed by the Canadian Advisory Council on Electrical Safety (CACES) Subcommittee on SPE-3000, under the jurisdiction of the CACES, and was formally approved by the CACES.

   Notes:

   1. Use of the singular does not exclude the plural (and vice versa) when the sense allows.

   2. Although the intended primary application of this Standard is stated in its Scope, it is important to note that it remains the responsibility of the users of the Standard to judge its suitability for their particular purpose.

   3. This Standard was developed by consensus, which is defined by CSA Policy governing standardization — Code of good practice for standardization as “substantial agreement. Consensus implies much more than a simple majority, but not necessarily unanimity”. It is consistent with this definition that a member may be included in the Technical Committee list and yet not be in full agreement with all clauses of this Standard.

   4. To submit a request for interpretation of this Standard, please send the following information to

      inquiries@csagroup.org and include “Request for interpretation” in the subject line:

      1. define the problem, making reference to the specific clause, and, where appropriate, include an illustrative sketch;

      2. provide an explanation of circumstances surrounding the actual field condition; and

      3. where possible, phrase the request in such a way that a specific “yes” or “no” answer will address the issue.

         Committee interpretations are processed in accordance with the CSA Directives and guidelines governing standardization and are available on the Current Standards Activities page at standardsactivities.csa.ca.

   5. This Standard is subject to review within five years from the date of publication. Suggestions for its improvement will be referred to the appropriate committee. To submit a proposal for change, please send the following information to inquiries@csagroup.org and include “Proposal for change” in the subject line:

      1. Standard designation (number);

      2. relevant clause, table, and/or figure number;

      3. wording of the proposed change; and

      4. rationale for the change.

April 2019 © 2019 Canadian Standards Association 8

CSA SPE-3000:19

Model Code for the field evaluation of medical electrical equipment

(MEE) and medical electrical systems (MES)

CSA SPE-3000:19

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

0 Introduction

The object of this Model Code is to facilitate a safety evaluation of medical electrical equipment (MEE) and medical electrical systems (MES). The safety considerations covered by this Code do not include requirements pertaining to risk analysis, evaluation of efficacy, or performance of products.

1 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:

1. custom-built equipment for special applications;

2. equipment manufactured on a non-repetitive basis;

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

April 2019 © 2019 Canadian Standards Association 9