|
SLOVENSKI STANDARD
01-julij-2018
1DGRPHãþD
SIST EN 60601-2-2:2009
SIST EN 60601-2-2:2009/A11:2012
0HGLFLQVNDHOHNWULþQDRSUHPDGHO 3RVHEQH]DKWHYH]DRVQRYQRYDUQRVWLQ
ELVWYHQHODVWQRVWLYLVRNRIUHNYHQþQHNLUXUãNHRSUHPHLQYLVRNRIUHNYHQþQHJD
NLUXUãNHJDSULERUD ,(&
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 60601-2-2:2017)
Medizinische elektrische Geräte - Teil 2-2: Besondere Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale von Hochfrequenz-Chirurgiegeräten
und HF-chirurgischem Zubehör (IEC 60601-2-2:2017)
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 (IEC 60601-2-
2:2017)
Ta slovenski standard je istoveten z: EN IEC 60601-2-2:2018
ICS:
11.040.30 Operacijski instrumenti in Surgical instruments and
materiali materials
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
EUROPEAN STANDARD EN IEC 60601-2-2
NORME EUROPÉENNE
EUROPÄISCHE NORM
May 2018
ICS 11.040.30 Supersedes EN 60601-2-2:2009
English Version
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 60601-2-2:2017)
Appareils électromédicaux - Partie 2-2: Exigences Medizinische elektrische Geräte - Teil 2-2: Besondere
particulières pour la sécurité de base et les performances Festlegungen für die Sicherheit einschließlich der
essentielles des appareils d'électrochirurgie à courant haute wesentlichen Leistungsmerkmale von Hochfrequenz-
fréquence et des accessoires d'électrochirurgie à courant Chirurgiegeräten
haute fréquence (IEC 60601-2-2:2017)
(IEC 60601-2-2:2017)
This European Standard was approved by CENELEC on 2017-05-05. CENELEC members are bound to comply with the CEN/CENELEC
Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by translation
under the responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the
same status as the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, the Netherlands, Norway, Poland, Portugal, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden,
Switzerland, Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2018 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN IEC 60601-2-2:2018 E
European foreword
The text of document 62D/1427/FDIS, future edition 6 of IEC 60601-2-2, prepared by SC 62D
"Electromedical equipment ", of IEC/TC 62 "Electrical equipment in medical practice" was submitted to
the IEC-CENELEC parallel vote and approved by CENELEC as EN IEC 60601-2-2:2018.
The following dates are fixed:
(dop) 2018-11-18
• latest date by which the document has to be
implemented at national level by
publication of an identical national
standard or by endorsement
• latest date by which the national (dow) 2021-05-18
standards conflicting with the
document have to be withdrawn
This document supersedes EN 60601-2-2:2009.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Endorsement notice
The text of the International Standard IEC 60602-2-2:2017 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards indicated:
IEC 60529 NOTE Harmonized as EN 60529.
IEC 60601-2-4:2010 NOTE Harmonized as EN 60601-2-4:2011.
IEC 60601-2-18:2009 NOTE Harmonized as EN 60601-2-18:2015.
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
NOTE 1 When an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is
available here: www.cenelec.eu.
Annex ZA of EN 60601-1:2006 applies, except as follows:
Publication Year Title EN/HD Year
Replacement in Annex ZA of EN 60601-1:2006:
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: General 2015
EN 60601-1-2
requirements for basic safety and essential
performance - Collateral Standard:
Electromagnetic disturbances - Requirements
and tests
IEC 60601-1-8 2006 Medical electrical equipment - Part 1-8: General EN 60601-1-8 2007
requirements for basic safety and essential
performance - Collateral Standard: General
requirements, tests and guidance for alarm
systems in medical electrical equipment and
medical electrical systems
Publication Year Title EN/HD Year
Addition to Annex ZA of EN 60601-1:2006:
CISPR 11 2015 Industrial, scientific and medical equipment - EN 55011 2016
Radio-frequency disturbance characteristics -
Limits and methods of measurement
IEC 61000-4-3 2006 Electromagnetic compatibility (EMC) - Part 4-3: EN 61000-4-3 2006
Testing and measurement techniques -
Radiated, radio-frequency, electromagnetic
field immunity test
IEC 61000-4-6 2013 Electromagnetic compatibility (EMC) - Part 4-6: EN 61000-4-6 2014
Testing and measurement techniques -
Immunity to conducted disturbances, induced
by radio-frequency fields
IEC 60601-2-2
Edition 6.0 2017-03
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
INTERNATIONALE
ICS 11.040.30 ISBN 978-2-8322-4008-3
– 2 – IEC 60601-2-2:2017 IEC 2017
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 . 14
201.5 General requirements for testing of ME EQUIPMENT . 15
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 15
201.7 ME EQUIPMENT identification, marking and documents . 15
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 20
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 36
201.10 Protection against unwanted and excessive radiation HAZARDS . 36
201.11 Protection against excessive temperatures and other HAZARDS . 36
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 38
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 43
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 44
201.15 Construction of ME EQUIPMENT . 44
201.16 ME SYSTEMS . 49
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 49
202 * ELECTROMAGNETIC DISTURBANCES – Requirements and tests . 49
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems . 50
Annexes . 51
Annex AA (informative) Particular guidance and rationale . 52
Annex BB (informative) ELECTROMAGNETIC DISTURBANCES created by HF SURGICAL
EQUIPMENT . 78
Bibliography . 87
Index of defined terms used in this particular standard . 89
Figure 201.101 – Symbol used with an EARTH REFERENCED PATIENT CIRCUIT . 16
Figure 201.102 – Symbol used with a HF ISOLATED PATIENT CIRCUIT . 16
Figure 201.103 – Circuit suitable for testing compliance to 201.8.4.101 . 22
Figure 201.104 – Measurement of HF LEAKAGE CURRENT for EARTH REFERENCED PATIENT
CIRCUITS and load between electrodes . 25
Figure 201.105 – Measurement of HF LEAKAGE CURRENT for EARTH REFERENCED PATIENT
CIRCUITS and a load resistance from ACTIVE ELECTRODE to earth . 26
Figure 201.106 – Measurement of HF LEAKAGE CURRENT for HF ISOLATED PATIENT
CIRCUITS . 27
Figure 201.107 – Measurement of HF LEAKAGE CURRENT from a BIPOLAR ACCESSORY . 28
Figure 201.108 – Test apparatus for anchorages of cords of ACTIVE ACCESSORY . 34
Figure 201.109 – Measurement of output power – MONOPOLAR output . 39
Figure 201.110 – Measurement of output power – BIPOLAR output . 40
IEC 60601-2-2:2017 IEC 2017 – 3 –
Figure 201.111 – Method of testing feedback from one active output to another in
simultaneous activation . 43
Figure AA.1 – Examples of various parts of an HF surgical ME SYSTEM . 54
Figure AA.2 – Example of MONOPOLAR method of HF surgery using a NEUTRAL
ELECTRODE . 54
Figure AA.3 – Example of BIPOLAR method of HF surgery . 55
Figure AA.4 – CREST FACTOR vs. peak voltage . 60
Figure AA.5 – Example of PATIENT circuit with NEUTRAL ELECTRODE referenced to earth
at operating frequencies . 64
Figure BB.1 – E-FIELD EMISSIONS test setup . 81
Figure BB.2 – H-FIELD EMISSIONS test setup . 82
Figure BB.3 – Conducted EMISSIONS test setup . 83
Figure BB.4 – Unit ad hoc test .
...