CSA C22.2 No. 60601-1-12:15

(IEC 60601-1-12:2014, MOD)

National Standard of Canada Norme nationale du Canada (reaffirmed/confirmée en 2020)

CSA C22.2 No. 60601-1-12:15

Medical electrical equipment — Part 1-12: General requirements for basic safety and essential performance — Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

(IEC 60601-1-12:2014, MOD)

CSA C22.2 nº 60601-1-12:15

Appareils électromédicaux — Partie 1-12 : Exigences générales pour la sécurité de base et les performances essentielles — Norme collatérale : Exigences pour les appareils électromédicaux et les systèmes électromédicaux destinés à être utilisés dans l'environnement des services médicaux d'urgence

(IEC 60601-1-12:2014, MOD)

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  CSA C22.2 No. 60601-1-12:15

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  Title: Medical electrical equipment — Part 1-12: General requirements for basic safety and essential performance — Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

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National Standard of Canada

CSA C22.2 No. 60601-1-12:15

Medical electrical equipment — Part 1-12: General requirements for basic safety and essential performance — Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

(IEC 60601-1-12:2014, MOD)

Prepared by

International Electrotechnical Commission

Reviewed by

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ICS 11.040

ISBN 978-1-4883-0319-7

© 2015 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 C22.2 No. 60601-1-12:15

Medical electrical equipment — Part 1-12: General requirements for basic safety and essential performance — Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

(IEC 60601-1-12:2014, MOD)

CSA Preface

This is the first edition of CAN/CSA-C22.2 No. 60601-1-12, Medical electrical equipment — Part 1-12: General requirements for basic safety and essential performance — Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-1-12 (first edition, 2014-06). It is one in a series of Standards issued by CSA under Part II of the Canadian Electrical Code.

For brevity, this Standard will be referred to as “CAN/CSA-C22.2 No. 60601-1-12” throughout.

This Standard is intended to be used in conjunction with CAN/CSA-C22.2 No. 60601-1:14, Medical electrical equipment — Part 1: General requirements for basic safety and essential performance (adopted IEC 60601-1:2005+A1:2012, with Canadian deviations).

This Standard is considered suitable for use for conformity assessment within the stated scope of the Standard.

This Standard was reviewed for Canadian adoption by the CSA Technical Committee on Consumer and Commercial Products, under the jurisdiction of the CSA Strategic Steering Committee on Requirements for Electrical Safety, and has been formally approved by the Technical Committee. Due to the medical content of this Standard, it was also approved by the CSA Technical Committee on Application of Electricity in Health Care under the jurisdiction of the CSA Strategic Steering Committee on Health Care Technology & Systems.

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.

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IEC 60601-1-12

INTERNATIONAL STANDARD

NORME INTERNATIONALE

Edition 1.0 2014-06

Medical electrical equipment –

Part 1-12: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

Appareils électromédicaux –

IEC 60601-1-12:2014-06(en-fr)

Partie 1-12: Exigences générales pour la sécurité de base et les performances essentielles – Norme collatérale: Exigences pour les appareils électromédicaux et les systèmes électromédicaux destinés à être utilisés dans l'environnement des services médicaux d'urgence

– 2 – IEC 60601-1-12:2014 © IEC 2014

CONTENTS

FOREWORD 4

INTRODUCTION 7

1. Scope, object and related standards 8

   1. * Scope 8

   2. * Object 8

   3. Related standards 9

      1.3.1 IEC 60601-1 9

      1.3.2 Particular standards 9

2. Normative references 9

3. Terms and definitions 10

4. General requirements 11

   1. * Additional requirements for SUPPLY MAINS for ME EQUIPMENT and ME SYSTEMS 11

   2. * Environmental conditions for ME EQUIPMENT 11

      1. * Environmental conditions of transport and storage between uses 12

      2. * Environmental operating conditions 13

5. * Classification of ME EQUIPMENT and ME SYSTEMS 15

6. ME EQUIPMENT identification, marking and documents 16

   1. * Additional requirements for legibility of markings 16

   2. * Additional requirements for marking of IP classification 16

   3. * Instructions for use 16

      1. Additional general requirements 16

      2. * Additional requirements for an electrical power source 17

      3. Additional requirements for ME EQUIPMENT start-up PROCEDURE 17

      4. * Additional requirements for operating instructions 18

      5. Additional requirements for ME EQUIPMENT messages 18

   4. Technical description – FIXED or PERMANENTLY INSTALLED CLASS I

      ME EQUIPMENT 18

7. * Protection against electrical HAZARDS from ME EQUIPMENT 18

8. Protection against excessive temperatures and other HAZARDS 19

   1. Additional requirements for ingress of water or particulate matter into

      ME EQUIPMENT and ME SYSTEMS 19

      1. * Ingress of water or particulate matter into ME EQUIPMENT 19

      2. * Ingress of water or particulate matter into ME SYSTEMS 19

   2. Additional requirements for interruption of the power supply to ME EQUIPMENT

      and ME SYSTEM 19

   3. * Additional requirements for INTERNAL ELECTRICAL POWER SOURCE for

      ME EQUIPMENT 20

9. * Accuracy of controls and instruments and protection against hazardous outputs 21

10. Construction of ME EQUIPMENT 21

    1. * Additional requirements for mechanical strength of ME EQUIPMENT intended

       for the EMS ENVIRONMENT 21

       1. General requirements for mechanical strength 21

       2. * Requirements for mechanical strength for FIXED or PERMANENTLY

          INSTALLED ME EQUIPMENT intended for use in a road ambulance 22

       3. * Requirements for mechanical strength for TRANSPORTABLE

          ME EQUIPMENT 23

          IEC 60601-1-12:2014 © IEC 2014 – 3 –

       4. * Requirements for mechanical strength for ME EQUIPMENT intended for

          airborne use 24

    2. Requirements for mounting of ME EQUIPMENT 25

11. Additional requirements for electromagnetic compatibility of ME EQUIPMENT and

ME SYSTEMS 25

Annex A (informative) General guidance and rationale 26

1. General guidance 26

2. Rationale for particular clauses and subclauses 28

Annex B (informative) Guide to marking and labelling requirements for ME EQUIPMENT

and ME SYSTEMS 42

1. Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts 42

2. ACCOMPANYING DOCUMENTS, instructions for use 42

3. ACCOMPANYING DOCUMENTS, technical description 43

Annex C (informative) Symbols on marking 44

Bibliography 46

Index of defined terms used in this collateral standard 48

Figure A.1 – Saturation water vapour pressure as function of temperature 31

Table 1 – Mechanical strength test applicability 22

Table A.1 – Saturation water vapour pressure as function of temperature 32

Table B.1 – Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts 42

Table B.2 – ACCOMPANYING DOCUMENTS, instructions for use 42

Table B.3 – ACCOMPANYING DOCUMENTS, technical description 43

Table C.1 – General symbols 44

– 8 – IEC 60601-1-12:2014 © IEC 2014

MEDICAL ELECTRICAL EQUIPMENT –

Part 1-12: General requirements for basic safety and essential performance –

Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use

in the emergency medical services environment

1. Scope, object and related standards

   
   

   1. * Scope

      
      

      This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS, which are intended, as indicated in the instructions for use by their MANUFACTURER, for use in the EMS ENVIRONMENT (EMERGENCY MEDICAL SERVICES

      ENVIRONMENT), as defined in 3.1.

      
      

      NOTE 1 For the purposes of this standard, the intent of the MANUFACTURER is indicated in the instructions for use. The RESPONSIBLE ORGANIZATION and the OPERATOR need to be aware that any other use outside the MANUFACTURER’S INTENDED USE can result in a HAZARDOUS SITUATION for the PATIENT.

      
      

      The EMS ENVIRONMENT includes

      
      

      • responding to and providing life support at the scene of an emergency to a PATIENT reported as experiencing injury or illness in a pre-hospital setting, and transporting the PATIENT, while continuing such life support care, to an appropriate professional healthcare facility for further care.

      • providing monitoring, treatment or diagnosis during transport between professional healthcare facilities.

      
      

      This International Standard does not apply to ME EQUIPMENT and ME SYSTEMS intended solely for use in the HOME HEALTHCARE ENVIRONMENT covered by IEC 60601-1-11 or solely for use in professional healthcare facilities covered by IEC 60601-1 without the additions of IEC 60601-1-11 or this collateral standard. ME EQUIPMENT and ME SYSTEMS are often not solely intended for one environment. Such ME EQUIPMENT or ME SYSTEM can be intended for multiple use environments, and as such, if also intended for use in the EMS ENVIRONMENT, are within the scope of this standard.

      
      

      EXAMPLE ME EQUIPMENT or ME SYSTEM intended for both the EMS ENVIRONMENT and the professional healthcare facility environment.

      
      

      NOTE 2 EMS ENVIRONMENT ME EQUIPMENT and ME SYSTEMS can be used in locations with unreliable electrical sources and outdoor environmental conditions.

      
      

   2. * Object

The object of this collateral standard is to provide general requirements for ME EQUIPMENT and ME SYSTEMS carried to the scene of an emergency and used there, as well as in transport, in situations where the ambient conditions differ from indoor conditions.

The object of this collateral standard is to specify general requirements that are in addition to those of the general standard and to serve as the basis for particular standards.