CSA C22.2 No. 80601-2-13:15

(ISO 80601-2-13:2011, MOD)

National Standard of Canada

(reaffirmed 2020)

CSA C22.2 No. 80601-2-13:15

Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

(ISO 80601-2-13:2011, MOD)

© ISO 2011. © Canadian Standards Association 2015. All rights reserved. Unauthorized reproduction is strictly prohibited.

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  CSA C22.2 No. 80601-2-13:15

  November 2015

  
  

  Title: Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

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National Standard of Canada

CSA C22.2 No. 80601-2-13:15

Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

(ISO 80601-2-13:2011, MOD)

Prepared by

International Organization for Standardization

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ICS 11.040.10

ISBN 978-1-77139-966-1

© 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. 80601-2-13:15

Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

CSA C22.2 No. 80601-2-13:15

Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

(ISO 80601-2-13:2011, MOD)

CSA Preface

This is the first edition of CAN/CSA-C22.2 No. 80601-2-13, Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation, which is an adoption, with Canadian deviations, of the identically titled ISO (International Organization for Standardization) Standard 80601-2-13 (first edition, 2011-08-01). It replaces the previous edition, published in 2007 as CAN/CSA-C22.2 No. 60601-2-13, Medical electrical equipment — Part 2-13: Particular requirements for the safety and essential performance of anaesthetic systems (adopted IEC 60601-2-13:2003+A1:2006). It is one in a series of Standards issued by CSA Group under Part II of the Canadian Electrical Code.

For brevity, this Standard will be referred to as “CAN/CSA-C22.2 No. 80601-2-13” 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 Perioperative Safety 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.

Interpretations: The Strategic Steering Committee on Requirements for Electrical Safety has provided the following direction for the interpretations of standards under its jurisdiction: “The literal text shall be used in judging compliance of products with the safety requirements of this Standard. When the literal text cannot be applied to the product, such as for new materials or construction, and when a relevant committee interpretation has not already been published, CSA Group’s procedures for interpretation shall be followed to determine the intended safety principle.”

November 2015 © 2015 Canadian Standards Association CSA/5

CSA C22.2 No. 80601-2-13:15

Medical electrical equipment — Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation

© 2015 Canadian Standards Association

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November 2015 © 2015 Canadian Standards Association CSA/6

INTERNATIONAL STANDARD

ISO 80601-2-13

First edition 2011-08-01

Medical electrical equipment —

Part 2-13:

Particular requirements for basic safety and essential performance of an anaesthetic workstation

Appareils électromédicaux —

Partie 2-13: Exigences particulières de sécurité de base et de performance essentielle pour les systèmes d'anesthésie

Reference number ISO 80601-2-13:2011(E)

© ISO 2011

ISO 80601-2-13:2011(E)

Contents Page

Foreword v

Introduction vi

1. Scope, object and related standards 1

2. Normative references 3

3. Terms and definitions 5

4. General requirements 9

5. General requirements for testing ME EQUIPMENT 11

6. Classification of ME EQUIPMENT and ME SYSTEMS 11

7. ME EQUIPMENT identification, marking and documents 11

8. Protection against electrical HAZARDS from ME EQUIPMENT 15

9. Protection against mechanical HAZARDS of ME EQUIPMENT and ME SYSTEMS 16

10. Protection against unwanted and excessive radiation HAZARDS 17

11. Protection against excessive temperatures and other HAZARDS 17

12. Accuracy of controls and instruments and protection against hazardous outputs 19

13. HAZARDOUS SITUATIONS and fault conditions 24

14. PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 24

15. Construction of ME EQUIPMENT 25

16. ME SYSTEMS 25

17. Electromagnetic compatibility of ME EQUIPMENT AND ME SYSTEMS 26

1. Additional requirements for ANAESTHETIC GAS DELIVERY SYSTEMS 26

2. Additional requirements for an ANAESTHETIC BREATHING SYSTEM 32

3. Additional requirements for an ANAESTHETIC GAS SCAVENGING SYSTEM 39

4. Additional requirements for an ANAESTHETIC VAPOUR DELIVERY SYSTEM 43

5. Additional requirements for an ANAESTHETIC VENTILATOR 47

   1. * Timed ventilatory pause 50

      1. Expiratory pause 50

      2. Inspiratory pause 50

1. Display loops 53

2. Clinical evaluation 53

1. Electromagnetic compatibility — Requirements and tests 54

2. General requirements for radiation protection in diagnostic X-ray equipment 54

206 Usability 54

1. General requirements, tests and guidance for ALARM SYSTEMS in MEDICAL ELECTRICAL

   EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS 55

2. Requirements for environmentally conscious design 55

   © ISO 2011 – All rights reserved

   CAN/CSA-C22.2 No. 80601-2-13:15

   iii

   ISO 80601-2-13:2011(E)

3. PROCESS requirements for the development of physiologic closed-loop controllers 56

4. Requirements for MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS used in

the home healthcare 56

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

SYSTEMS or their parts 57

Annex D (informative) Symbols on marking 67

Annex AA (informative) Particular guidance and rationale 69

Annex BB (normative) Test for flammability of anaesthetic agent 84

Annex CC (informative) Environmental aspects 85

Annex DD (informative) Reference to the essential principles 87

Bibliography 94

Alphabetized index of defined terms used in this particular standard 96

iv CAN/CSA-C22.2 No. 80601-2-13:15

© ISO 2011 – All rights reserved

INTERNATIONAL STANDARD ISO 80601-2-13:2011(E)

Medical electrical equipment —

Part 2-13:

Particular requirements for basic safety and essential performance of an anaesthetic workstation

201.1 Scope, object and related standards

IEC 60601-1:2005, Clause 1 applies, except as follows:

201.1.1 * Scope

Replacement:

This International Standard is applicable to the BASIC SAFETY and ESSENTIAL PERFORMANCE of an ANAESTHETIC WORKSTATION for administering inhalational anaesthesia whilst continuously attended by a professional OPERATOR.

This International Standard specifies particular requirements for a complete ANAESTHETIC WORKSTATION and the following ANAESTHETIC WORKSTATION components which, although considered as individual devices in their own right, may be utilized, in conjunction with other relevant ANAESTHETIC WORKSTATION components, to form an ANAESTHETIC WORKSTATION to a given specification:

• ANAESTHETIC GAS DELIVERY SYSTEM;

  
  

• ANAESTHETIC BREATHING SYSTEM;

  
  

• ANAESTHETIC GAS SCAVENGING SYSTEM;

  
  

• ANAESTHETIC VAPOUR DELIVERY SYSTEM;

  
  

• ANAESTHETIC VENTILATOR;

  
  

• MONITORING EQUIPMENT;

  
  

• ALARM SYSTEM;

  
  

• PROTECTION DEVICE.

NOTE 1 MONITORING EQUIPMENT, ALARM SYSTEMS and PROTECTION DEVICES are summarized in Table AA.1.

An ANAESTHETIC WORKSTATION supplied complete and its individual components are considered as ME EQUIPMENT or ME SYSTEMS with regard to the general standard.

NOTE 2 The applicability of this International Standard is indicated in Table AA.2.

This International Standard is also applicable to those ACCESSORIES intended by their MANUFACTURER to be connected to an ANAESTHETIC WORKSTATION where the characteristics of those ACCESSORIES can affect the BASIC SAFETY and ESSENTIAL PERFORMANCE of the ANAESTHETIC WORKSTATION.

© ISO 2011 – All rights reserved

CAN/CSA-C22.2 No. 80601-2-13:15 1