IEC 60601-2-36:2014

Medical electrical equipment - Part 2-36: Particular requirements for the basic safety and essential performance of equipment for extracorporeally induced lithotripsy

IEC 60601-2-36:2014 applies to basic safety and essential performance of equipment for extracorporeally induced lithotripsy including equipment for other medical applications of therapeutic extracorporeally induced focused pressure pulses. The applicability of this particular standard is limited to components directly involved in the lithotripsy treatment, such as, but not limited to, the generator of the pressure pulse, patient support device, and their interactions with imaging and monitoring devices. Other devices, such as patient treatment planning computers, X-ray and ultrasonic devices, are excluded from this standard, because they are treated in other applicable IEC standards. This particular standard does not apply to ultrasound physiotherapy equipment intended to be used for physiotherapy; abd to ultrasound equipment intended to be used for high intensity therapeutic ultrasound (HITU) and other therapy equipment as described in Annex AA. This second edition cancels and replaces the first edition of IEC 60601-2-36 published in 1997. This edition constitutes a technical revision to align structurally with IEC 60601-1:2005 and its Amendment1:2012.

Appareils électromédicaux - Partie 2-36: Exigences particulières pour la sécurité de base et les performances essentielles des appareils pour lithotritie créée de façon extracorporelle

L'IEC 60601-2-36:2014 s'applique à la sécurité de base et aux performances essentielles des appareils pour lithotritie créée de façon extracorporelle, y compris des appareils pour d'autres applications médicales des impulsions de pression focalisées thérapeutiques créées de façon extracorporelle. La possibilité d'appliquer la présente norme particulière est limitée aux éléments directement en cause dans le traitement par lithotritie tels que, sans être exclusif, le générateur d'impulsions de pression, le dispositif supportant le patient, et leurs interactions avec les dispositifs d'imagerie et de surveillance. D'autres dispositifs, tels que les calculateurs organisant le traitement du patient, les dispositifs à rayonnement X et à ultrasons, sont exclus de la présente norme, car ils font l'objet d'autres normes IEC applicables. La présente norme particulière ne s'applique pas aux appareils à ultrasons prévus pour être utilisés en physiothérapie; et aux appareils à ultrasons prévus pour être utilisés en thérapie HITU (ultrasonore thérapeutique de haute intensité) et autres appareils de thérapie décrits à l'Annexe AA. Cette deuxième édition annule et remplace la première édition de l'IEC 60601-2-36 parue en 1997. Cette édition constitue une révision technique et s'aligne structurellement avec l'IEC 60601-1:2005 et son Amendement 1:2012.

General Information

• Status: Published
• Publication Date: 09-Apr-2014
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: MT 24 - TC 62/SC 62D/MT 24
• Current Stage: PPUB - Publication issued
• Start Date: 30-Apr-2014
• Completion Date: 10-Apr-2014

Relations

• Revises: IEC 60601-2-36:1997 - Medical electrical equipment - Part 2: Particular requirements for the safety of equipment for extracorporeally induced lithotripsy
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-36 ®
Edition 2.0 2014-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-36: Particular requirements for the basic safety and essential performance
of equipment for extracorporeally induced lithotripsy

Appareils électromédicaux –
Partie 2-36: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils pour lithotritie créée de façon extracorporelle

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IEC 60601-2-36 ®
Edition 2.0 2014-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –

Part 2-36: Particular requirements for the basic safety and essential performance

of equipment for extracorporeally induced lithotripsy

Appareils électromédicaux –
Partie 2-36: Exigences particulières pour la sécurité de base et les performances

essentielles des appareils pour lithotritie créée de façon extracorporelle

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX S
ICS 11.040.01 ISBN 978-2-8322-1498-5

– 2 – IEC 60601-2-36:2014  IEC 2014
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 8
201.3 Terms and definitions . 9
201.4 General requirements . 10
201.5 General requirements for testing ME EQUIPMENT . 10
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 11
201.7 ME EQUIPMENT identification, marking and documents . 11
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 12
201.9 Protection against MECHANICAL HAZARDS OF ME EQUIPMENT and ME SYSTEMS . 12
201.10 Protection against unwanted and excessive radiation HAZARDS . 13
201.11 Protection against excessive temperatures and other HAZARDS . 13
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 13
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 14
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 15
201.15 Construction of ME EQUIPMENT . 15
201.16 ME SYSTEMS . 15
201.17 ELECTROMAGNETIC COMPATIBILITY of ME EQUIPMENT and ME SYSTEMS . 15
202 * ELECTROMAGNETIC COMPATIBILITY – Requirements and tests . 15
Annexes . 15
Annex AA (informative) Particular guidance and rationale . 16
Annex BB (informative) Definition of coordinates, FOCUS and TARGET LOCATION . 17
Bibliography . 18
Index of defined terms used in this particular standard . 20

Figure BB.1 – Geometrical FOCUS distribution . 17

INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-36: Particular requirements for the basic safety and essential
performance of equipment for extracorporeally induced lithotripsy

FOREWORD
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International standard IEC 60601-2-36 has been prepared by IEC subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
This second edition cancels and replaces the first edition of IEC 60601-2-36 published in
1997. This edition constitutes a technical revision to align structurally with IEC 60601-1:2005
and its Amendment 1:2012).
– 4 – IEC 60601-2-36:2014  IEC 2014
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/1109/FDIS 62D/1122/RVD
Full information on the voting for the approval of this particular standard can be found in the
report on voting indicated in the above table.
This publication has been drafted in accordance with the ISO/IEC Directives, Part 2.
In this standard, the following print types are used:
– Requirements and definitions: roman type.
– Test specifications: italic type.
– Informative material appearing outside of tables, such as notes, examples and references: in smaller type.
Normative text of tables is also in a smal
...