CSA C22.2 No. 60601-2-65:15

(IEC 60601-2-65:2012+A1:2017, MOD)

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

CSA C22.2 No. 60601-2-65:15

Medical electrical equipment — Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment

(IEC 60601-2-65:2012+A1:2017, MOD)

CSA C22.2 nº 60601-2-65:15

Appareils électromédicaux — Partie 2-65 : Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X dentaires intra-oraux

(IEC 60601-2-65:2012+A1:2017, MOD)

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  CSA C22.2 No. 60601-2-65:15

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CSA C22.2 No. 60601-2-65:15

Medical electrical equipment — Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment (IEC 60601-2-65:2012+A1:2017, MOD)

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ICS 11.040.50

ISBN 978-1-4883-2141-2

© 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 C22.2 No. 60601-2-65:15

Medical electrical equipment — Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment

(IEC 60601-2-65:2012+A1:2017, MOD)

CSA Preface

This is consolidated edition 1.1 of CAN/CSA-C22.2 No. 60601-2-65, Medical electrical equipment – Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment, which is an adoption, with Canadian deviations, of the identically titled IEC (International Electrotechnical Commission) Standard 60601-2-65 (edition 1:2012 consolidated with Amendment 1:2017). 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. 60601-2-65” 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, including Amendment 1:2012, with Canadian deviations).

Where differences exist between this consolidated edition and the published edition and its amendments, those documents will take precedence.

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.

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IEC 60601-2-65

®

Edition 1.1 2017-05

CONSOLIDATED VERSION

VERSION CONSOLIDÉE

colour inside

Medical electrical equipment –

Part 2-65: Particular requirements for the basic safety and essential performance of dental intra-oral X-ray equipment

Appareils électromédicaux –

IEC 60601-2-65:2012-09+AMD1:2017-05 CSV(en-fr)

Partie 2-65: Exigences particulières pour la sécurité de base et les performances essentielles des appareils à rayonnement X dentaires intra-oraux

– 2 – IEC 60601-2-65:2012+AMD1:2017 CSV

 IEC 2017

CONTENTS

FOREWORD 3

INTRODUCTION 6

INTRODUCTION TO AMENDMENT 1 6

1. Scope, object and related standards 7

2. Normative references 9

3. Terms and definitions 9

4. General requirements 11

5. General requirements for testing of ME EQUIPMENT 11

6. Classification of ME EQUIPMENT and ME SYSTEMS 12

7. ME EQUIPMENT identification, marking and documents 12

8. Protection against electrical HAZARDS from ME EQUIPMENT 14

9. Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS 15

10. Protection against unwanted and excessive radiation HAZARDS 15

11. Protection against excessive temperatures and other HAZARDS 16

12. Accuracy of controls and instruments and protection against hazardous

    outputs 16

13. HAZARDOUS SITUATIONS and fault conditions 16

14. PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) 16

15. Construction of ME EQUIPMENT 16

16. ME SYSTEMS 16

17. Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS 16

1. Electromagnetic compatibility – Requirements and tests 16

2. Radiation protection in diagnostic X-ray equipment 17

Annexes 27

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

and ME SYSTEMS 28

Annex AA (informative) Particular guidance and rationale 29

Annex BB (informative) Identification of parts of dental X-RAY INTRA-ORAL SYSTEMS in

relation to defined terms in this standard 36

Bibliography 38

Index of defined terms used in this particular standard 41

Figure AA.1 – AIR KERMA during IRRADIATION with direct current X-RAY GENERATOR 30

Figure AA.2 – AIR KERMA during IRRADIATION with ONE-PEAK X-RAY GENERATOR 32

Figure AA.3 – Waveform of long IRRADIATION TIME X-RADIATION from a

ONE-PEAK X-RAY GENERATOR 33

Figure BB.1 – Structure of DENTAL INTRA-ORAL X-RAY EQUIPMENT 36

Figure BB.2 – Parts of DENTAL INTRA-ORAL X-RAY EQUIPMENT 37

Table 201.101 – List of potential ESSENTIAL PERFORMANCE to be considered by

MANUFACTURER in the RISK MANAGEMENT PROCESS 11

Table 201.C.101 – Marking on the outside of ME EQUIPMENT or its parts 28

Table 201.C.102 – Subclauses requiring statements in ACCOMPANYING DOCUMENTS 28

IEC 60601-2-65:2012+AMD1:2017 CSV – 7 –

 IEC 2017

MEDICAL ELECTRICAL EQUIPMENT –

Part 2-65: Particular requirements for the basic safety

and essential performance of dental intra-oral X-ray equipment

201.1 Scope, object and related standards

Clause 1 of the general standard 1 applies, except as follows:

201.1.1 Scope

Replacement:

This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of DENTAL INTRA-ORAL X-RAY EQUIPMENT and its main components, hereafter also called ME EQUIPMENT.

The scope of this standard is restricted to X-RAY EQUIPMENT where the X-RAY TUBE ASSEMBLY

contains the HIGH-VOLTAGE TRANSFORMER ASSEMBLY.

DENTAL EXTRA-ORAL X-RAY EQUIPMENT is excluded from the scope of this standard

NOTE 1 The X-RAY GENERATOR in DENTAL INTRA-ORAL X-RAY EQUIPMENT always comprises an X-RAY MONOBLOCK

ASSEMBLY. Therefore in this particular standard the concept of X-RAY TUBE ASSEMBLY is replaced by that of X-RAY MONOBLOCK ASSEMBLY.

NOTE 2 Main components may be for instance the X-RAY MONOBLOCK ASSEMBLY and an ELECTRONIC X-RAY IMAGE RECEPTOR.

NOTE 3 Photostimulated phosphor plates and their readers (hardware and software) are excluded from the scope of this particular standard, since they have no electrical APPLIED PARTS in the PATIENT ENVIRONMENT, and are not ME EQUIPMENT.

ME EQUIPMENT and ME SYSTEMS in the scope of IEC 60601-2-63, IEC 60601-2-44,

IEC 60601-2-54, IEC 60601-2-45 or IEC 60601-2-43 are excluded from the scope of this particular standard. The scope of this International Standard also excludes RADIOTHERAPY SIMULATORS and equipment for bone or tissue absorption densitometry. Excluded from the scope is also ME EQUIPMENT intended to be used for DENTAL RADIOSCOPY.

Within its specific scope, the clauses of this particular standard supersede and replace those of IEC 60601-2-7, Medical electrical equipment – Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators and of IEC 60601-2-32, Medical electrical equipment – Particular requirements for the safety of associated equipment of X-ray equipment.

NOTE 4 Requirements for X-RAY GENERATORS and for ASSOCIATED EQUIPMENT, which were previously specified in IEC 60601-2-7 and IEC 60601-2-32, have been included in either IEC 60601-1:2005 (Ed3) or in this particular

rd

standard. Therefore IEC 60601-2-7 and IEC 60601-2-32 are not part of the IEC 60601-1 3

DENTAL INTRA-ORAL X-RAY EQUIPMENT.

edition scheme for

All requirements addressing integrated X-RAY TUBE ASSEMBLIES are covered by this particular standard. Therefore IEC 60601-2-28 does not apply to ME EQUIPMENT in the scope of this International Standard.

—————————

1 The general standard is IEC 60601-1:2005 and IEC 60601-1:2005/AMD1:2012, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance