IEC 60601-2-2:2009

Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories

IEC 60601-2-2:2009 specifies particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories. This particular standard amends and supplements IEC 60601-1 (third edition, 2005): Medical electrical equipment - Part 1: General requirements for basic safety and essential performance. This fifth edition cancels and replaces the fourth edition published in 2006. This edition constitutes a technical revision. Revisions in this edition include new language for preconditioning accessories prior to insulation testing, refining the requirements for electromagnetic compatibility testing and correcting some of the equations used in deriving the thermal test for neutral electrodes.
The contents of the corrigendum of February 2014 have been included in this copy.

Appareils électromédicaux - Partie 2-2: Exigences particulières pour la sécurité de base et les performances essentielles des appareils d'électrochirurgie à courant haute fréquence et des accessoires d'électrochirurgie à courant haute fréquence

La CEI 60601-2-2:2009 spécifie des exigences particulières pour la sécurité de base et les performances essentielles des appareils d'électrochirurgie à courant haute fréquence et des accessoires d'électrochirurgie à courant haute fréquence. La présente norme particulière modifie et complète la CEI 60601-1 (troisième édition, 2005): Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles. Cette cinquième édition annule et remplace la quatrième édition publiée en 2006 dont elle constitue une révision technique. Les révisions de la présente édition incluent de nouveaux termes relatifs au préconditionnement des accessoires préalablement à l'essai d'isolement, à l'affinement des exigences applicables aux essais de compatibilité électromagnétique et à la correction de certaines équations utilisées dans le calcul de l'essai thermique applicable aux électrodes neutres.
Le contenu du corrigendum de février 2014 a été pris en considération dans cet exemplaire.

General Information

• Status: Published
• Publication Date: 22-Feb-2009
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: SC 62D - Particular medical equipment, software, and systems
• Drafting Committee: MT 17 - TC 62/SC 62D/MT 17
• Current Stage: DELPUB - Deleted Publication
• Completion Date: 31-Mar-2017

Relations

• Corrected By: IEC 60601-2-2:2009/COR1:2014 - Corrigendum 1 - Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
• Effective Date: 05-Sep-2023
• Revises: IEC 60601-2-2:2006 - Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment
• Effective Date: 05-Sep-2023
• Revised: IEC 60601-2-2:2017 - Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-2-2 ®
Edition 5.0 2009-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-2: Particular requirements for the basic safety and essential performance
of high frequency surgical equipment and high frequency surgical accessories

Appareils électromédicaux –
Partie 2-2: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils d'électrochirurgie à courant haute fréquence et des
accessoires d'électrochirurgie à courant haute fréquence

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IEC 60601-2-2 ®
Edition 5.0 2009-02
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-2: Particular requirements for the basic safety and essential performance
of high frequency surgical equipment and high frequency surgical accessories

Appareils électromédicaux –
Partie 2-2: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils d'électrochirurgie à courant haute fréquence et des
accessoires d'électrochirurgie à courant haute fréquence

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
XC
CODE PRIX
ICS 11.040.30 ISBN 978-2-88910-213-6
– 2 – 60601-2-2 © IEC:2009
CONTENTS
FOREWORD.4
INTRODUCTION.7
201.1 Scope, object and related standards .8
201.2 Normative references .9
201.3 Terms and definitions.10
201.4 General requirements.13
201.5 General requirements for testing of ME EQUIPMENT.14
201.6 Classification of ME EQUIPMENT and ME SYSTEMS .14
201.7 ME EQUIPMENT identification, marking and documents.14
201.8 Protection against electrical HAZARDS from ME EQUIPMENT.19
201.9 Protection against mechanical hazards of ME EQUIPMENT and ME SYSTEMS.33
201.10 Protection against unwanted and excessive radiation HAZARDS.33
201.11 Protection against excessive temperatures and other HAZARDS.34
201.12 Accuracy of controls and instruments and protection against hazardous
outputs.35
201.13 HAZARDOUS SITUATIONS and fault conditions.41
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) .42
201.15 Construction of ME EQUIPMENT .42
201.16 ME SYSTEMs .46
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS .46
202 * Electromagnetic compatibility – Requirements and tests .46
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems.47
Annexes .47
Annex AA (informative) Particular guidance and rationale.48
Annex BB (informative) ELECTROMAGNETIC DISTURBANCES created by HF SURGICAL
EQUIPMENT .70
Bibliography.79

Figure 201.101 – Symbol used with an EARTH REFERENCED PATIENT CIRCUIT.14
HF ISOLATED PATIENT CIRCUIT .15
Figure 201.102 – Symbol used with a
Figure 201.103 – Circuit suitable for testing compliance to 201.8.4.101 .20
Figure 201.104 – Measurement of HF LEAKAGE CURRENT with NEUTRAL ELECTRODE
referenced to earth and load between electrodes.23
Figure 201.105 – Measurement of HF LEAKAGE CURRENT with NEUTRAL ELECTRODE
referenced to earth and load from ACTIVE ELECTRODE to earth .24
Figure 201.106 – Measurement of HF LEAKAGE CURRENT with NEUTRAL ELECTRODE
isolated from earth at HIGH FREQUENCY.25
Figure 201.107 – Measurement of HF LEAKAGE CURRENT from a BIPOLAR ELECTRODE .26
Figure 201.108 – Test apparatus for anchorages of cords of ACTIVE ACCESSORY.32
Figure 201.109 – Measurement of output power – MONOPOLAR output .37
Figure 201.110 – Measurement of output power – BIPOLAR output.38

60601-2-2 © IEC:2009 – 3 –
Figure 201.111 – Method of testing feedback from one active output to another in
simultaneous activation.41
Figure AA.1 – Example of various parts of an HF surgical system.49
Figure AA.2 – CREST FACTOR vs. peak voltage .53
Figure AA.3 – Example of PATIENT circuit with NEUTRAL ELECTRODE referenced to earth
at operating frequencies .57
Figure BB.1 – E-FIELD EMISSIONS test setup.73
Figure BB.2 – H-FIELD EMISSIONS test setup .74
Figure BB.3 – Conducted EMISSIONS test setup .75
Figure BB.4 – Unit ad hoc test .77
Figure BB.5 – Power cord ad hoc test.78
Figure BB.6 – ACCESSORY cord ad hoc test .78

Table 201.101 – Colours of indicator lights and their meaning for HF SURGICAL
EQUIPMENT .15
Table 201.102 – Maximum output powers in SINGLE FAULT CONDITIONS .40
Table 201.103 – Test currents by weight range.44
Table AA.1 – Summary of measured current and durations for 25 TUR procedures.65
Table AA.2 – Summary of measured currents and durations for general surgical
procedures .66
Table BB.1 – Worst case emissions of spark gap type HF SURGICAL EQUIPMENT .76
Table BB.2 – Worst case emissions of non-spark gap (modern) HF SURGICAL EQUIPMENT .76

– 4 – 60601-2-2 © IEC:2009
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –

Part 2-2: Particular requirements for the basic safety and essential
performance of high frequency surgical equipment and
high frequency surgical accessories

FOREWORD
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