IEC 60601-2-6:2012
(Main)Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
Medical electrical equipment - Part 2-6: Particular requirements for the basic safety and essential performance of microwave therapy equipment
IEC 60601-2-6:2012 specifies the minimum requirements considered to provide for a practical degree of safety in the operation of microwave therapy equipment. This particular standard amends and supplements IEC 60601-1 (third edition, 2005 and amendment 1, 2012). This second edition cancels and replaces the first edition of IEC 60601-2-6, published in 1984. This edition constitutes a technical revision and has been aligned to the third edition of IEC 60601-1:2005+A1:2012.
Appareils électromédicaux - Partie 2-6: Exigences particulières pour la sécurité de base et les performances essentielles des appareils de thérapie à micro-ondes
La CEI 60601-2-6:2012 spécifie les exigences minimales considérées comme assurant un degré pratique de sécurité dans le fonctionnement des appareils de thérapie à micro-ondes. La présente norme particulière modifie et complète la CEI 60601-1 (troisième édition, 2005 et amendement 1, 2012). Cette deuxième édition annule et remplace la première édition de la CEI 60601-2-6, publiée en 1984. Cette édition constitue une révision technique et s'aligne avec la troisième édition de la CEI 60601-1:2005+A1:2012.
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IEC 60601-2-6 ®
Edition 2.0 2012-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-6: Particular requirements for the basic safety and essential performance
of microwave therapy equipment
Appareils électromédicaux –
Partie 2-6: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de thérapie à micro-ondes
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester.
If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication,
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Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite ni
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International Standards for all electrical, electronic and related technologies.
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IEC 60601-2-6 ®
Edition 2.0 2012-04
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
Medical electrical equipment –
Part 2-6: Particular requirements for the basic safety and essential performance
of microwave therapy equipment
Appareils électromédicaux –
Partie 2-6: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de thérapie à micro-ondes
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX S
ICS 11.040.60 ISBN 978-2-88912-062-8
– 2 – 60601-2-6 © IEC:2012
CONTENTS
FOREWORD . 3
INTRODUCTION . 5
201.1 Scope, object and related standards . 6
201.2 Normative references . 7
201.3 Terms and definitions . 7
201.4 General requirements . 8
201.5 General requirements for testing of ME EQUIPMENT . 8
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 9
201.7 ME EQUIPMENT identification, marking and documents. 9
201.8 Protection against electrical HAZARDS from ME EQUIPMENT . 11
201.9 Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS . 11
201.10 Protection against unwanted and excessive radiation HAZARDS . 11
201.11 Protection against excessive temperatures and other HAZARDS . 12
201.12 Accuracy of controls and instruments and protection against hazardous
outputs . 12
201.13 HAZARDOUS SITUATIONS and fault conditions . 14
201.14 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) . 14
201.15 Construction of ME EQUIPMENT . 14
201.16 ME SYSTEMS . 14
201.17 Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS . 14
202 Electromagnetic compatibility – Requirements and tests . 14
Annexes . 15
ANNEX C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 16
Annex AA (informative) Particular guidance and rationale . 17
Index of defined terms used in this particular standard. 20
Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements . 8
Table 201.C.101 – Marking on the outside of MICROWAVE THERAPY EQUIPMENT or its
parts . 16
Table 201.C.102 – Marking on the inside of MICROWAVE THERAPY EQUIPMENT or its parts . 16
60601-2-6 © IEC:2012 – 3 –
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-6: Particular requirements for the basic safety and
essential performance of microwave therapy equipment
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
International standard IEC 60601-2-6 has been prepared by 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 60601-2-6, published in
1984. This edition constitutes a technical revision and has been aligned to the third edition of
IEC 60601-1:2005+A1:2012.
The text of this particular standard is based on the following documents:
FDIS Report on voting
62D/985/FDIS 62D/1008/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.
– 4 – 60601-2-6 © IEC:2012
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 smaller type.
– TERMS DEFINED IN CLAUSE 3 OF THE GENERAL STANDARD, IN THIS PARTICULAR STANDARD OR AS
NOTED: SMALL CAPITALS.
In referring to the structure of this standard, the term
– “clause” means one of the seventeen numbered divisions within the table of contents,
inclusive of all subdivisions (e.g. Clause 7 includes subclauses 7.1, 7.2, etc.);
– “subclause” means a numbered subdivision of a clause (e.g. 7.1, 7.2 and 7.2.1 are all
subclauses of Clause 7).
References to clauses within this standard are preceded by the term “Clause” followed by the
clause number. References to subclauses within this particular standard are by number only.
In this standard, the conjunctive “or” is used as an “inclusive or” so a statement is true if any
combination of the conditions is true.
The verbal forms used in this standard conform to usage described in Annex H of the ISO/IEC
Directives, Part 2. For the purposes of this standard, the auxiliary verb:
– “sh
...
IEC 60601-2-6 ®
Edition 2.2 2022-09
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-6: Particular requirements for the basic safety and essential performance
of microwave therapy equipment
Appareils électromédicaux –
Partie 2-6: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de thérapie à micro-ondes
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.
IEC Secretariat Tel.: +41 22 919 02 11
3, rue de Varembé info@iec.ch
CH-1211 Geneva 20 www.iec.ch
Switzerland
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigendum or an amendment might have been published.
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IEC 60601-2-6 ®
Edition 2.2 2022-09
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-6: Particular requirements for the basic safety and essential performance
of microwave therapy equipment
Appareils électromédicaux –
Partie 2-6: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de thérapie à micro-ondes
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.60 ISBN 978-2-8322-5710-4
IEC 60601-2-6 ®
Edition 2.2 2022-09
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 2-6: Particular requirements for the basic safety and essential performance
of microwave therapy equipment
Appareils électromédicaux –
Partie 2-6: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de thérapie à micro-ondes
– 2 – IEC 60601-2-6:2012+AMD1:2016
+AMD2:2022 CSV © IEC 2022
CONTENTS
FOREWORD . 3
INTRODUCTION . 6
INTRODUCTION to Amendment 2 . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 8
201.3 Terms and definitions . 8
201.4 General requirements . 9
201.5 General requirements for testing of ME EQUIPMENT . 10
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 10
201.7 ME EQUIPMENT identification, marking and documents . 10
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 . 12
201.11 Protection against excessive temperatures and other HAZARDS . 13
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 14
201.13 HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT . 15
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 . 16
202 Electromagnetic compatibility disturbances – requirements and tests . 16
Annexes . 16
ANNEX C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 17
Annex AA (informative) Particular guidance and rationale . 18
Index of defined terms used in this particular standard. 21
Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements . 10
Table 201.C.101 – Marking on the outside of MICROWAVE THERAPY EQUIPMENT or its
parts . 17
Table 201.C.102 – Marking on the inside of MICROWAVE THERAPY EQUIPMENT or its parts . 17
+AMD2:2022 CSV © IEC 2022
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-6: Particular requirements for the basic safety and
essential performance of microwave therapy equipment
FOREWORD
1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising
all national electrotechnical committees (IEC National Committees). The object of IEC is to promote
international co-operation on all questions concerning standardization in the electrical and electronic fields. To
this end and in addition to other activities, IEC publishes International Standards, Technical Specifications,
Technical Reports, Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC
Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested
in the subject dealt with may participate in this preparatory work. International, governmental and non-
governmental organizations liaising with the IEC also participate in this preparation. IEC collaborates closely
with the International Organization for Standardization (ISO) in accordance with conditions determined by
agreement between the two organizations.
2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international
consensus of opinion on the relevant subjects since each technical committee has representation from all
interested IEC National Committees.
3) IEC Publications have the form of recommendations for international use and are accepted by IEC National
Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC
Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any
misinterpretation by any end user.
4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications
transparently to the maximum extent possible in their national and regional publications. Any divergence
between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in
the latter.
5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity
assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any
services carried out by independent certification bodies.
6) All users should ensure that they have the latest edition of this publication.
7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and
members of its technical committees and IEC National Committees for any personal injury, property damage or
other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and
expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC
Publications.
8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is
indispensable for the correct application of this publication.
9) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of
patent rights. IEC shall not be held responsible for identifying any or all such patent rights.
This consolidated version of the official IEC Standard and its amendments has been
prepared for user convenience.
IEC 60601-2-6 edition 2.2 contains the second edition (2012-04) [documents
62D/985/FDIS and 62D/1008/RVD], its amendment 1 (2016-04) [documents
62D/1331/FDIS and 62D/1351/RVD] and its amendment 2 (2022-09) [documents
62D/1847/CDV and 62D/1960/RVC].
In this Redline version, a vertical line in the margin shows where the technical content
is modified by amendments 1 and 2. Additions are in green text, deletions are in
strikethrough red text. A separate Final version with all changes accepted is available
in this publication.
International standard IEC 60601-2-6 has been prepared by subcommittee 62D:
Electromedical equipment, of IEC technical committee 62: Electrical equipment in medical
practice.
– 4 – IEC 60601-2-6:2012+AMD1:2016
+AMD2:2022 CSV © IEC 2022
This second edition cancels and replaces the first edition of IEC 60601-2-6, published in
1984. This edition constitutes a tech
...
IEC 60601-2-6 ®
Edition 2.1 2016-04
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-6: Particular requirements for the basic safety and essential performance
of microwave therapy equipment
Appareils électromédicaux –
Partie 2-6: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de thérapie à micro-ondes
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form
or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from
either IEC or IEC's member National Committee in the country of the requester. If you have any questions about IEC
copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or
your local IEC member National Committee for further information.
Droits de reproduction réservés. Sauf indication contraire, aucune partie de cette publication ne peut être reproduite
ni utilisée sous quelque forme que ce soit et par aucun procédé, électronique ou mécanique, y compris la photocopie
et les microfilms, sans l'accord écrit de l'IEC ou du Comité national de l'IEC du pays du demandeur. Si vous avez des
questions sur le copyright de l'IEC ou si vous désirez obtenir des droits supplémentaires sur cette publication, utilisez
les coordonnées ci-après ou contactez le Comité national de l'IEC de votre pays de résidence.
IEC Central Office Tel.: +41 22 919 02 11
3, rue de Varembé Fax: +41 22 919 03 00
CH-1211 Geneva 20 info@iec.ch
Switzerland www.iec.ch
About the IEC
The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes
International Standards for all electrical, electronic and related technologies.
About IEC publications
The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the
latest edition, a corrigenda or an amendment might have been published.
IEC Catalogue - webstore.iec.ch/catalogue Electropedia - www.electropedia.org
The stand-alone application for consulting the entire The world's leading online dictionary of electronic and
bibliographical information on IEC International Standards, electrical terms containing 20 000 terms and definitions in
Technical Specifications, Technical Reports and other English and French, with equivalent terms in 15 additional
documents. Available for PC, Mac OS, Android Tablets and languages. Also known as the International Electrotechnical
iPad. Vocabulary (IEV) online.
IEC publications search - www.iec.ch/searchpub IEC Glossary - std.iec.ch/glossary
The advanced search enables to find IEC publications by a 65 000 electrotechnical terminology entries in English and
variety of criteria (reference number, text, technical French extracted from the Terms and Definitions clause of
committee,…). It also gives information on projects, replaced IEC publications issued since 2002. Some entries have been
and withdrawn publications. collected from earlier publications of IEC TC 37, 77, 86 and
CISPR.
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also once a month by email. need further assistance, please contact the Customer Service
Centre: csc@iec.ch.
A propos de l'IEC
La Commission Electrotechnique Internationale (IEC) est la première organisation mondiale qui élabore et publie des
Normes internationales pour tout ce qui a trait à l'électricité, à l'électronique et aux technologies apparentées.
A propos des publications IEC
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IEC 60601-2-6 ®
Edition 2.1 2016-04
CONSOLIDATED VERSION
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
Medical electrical equipment –
Part 2-6: Particular requirements for the basic safety and essential performance
of microwave therapy equipment
Appareils électromédicaux –
Partie 2-6: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de thérapie à micro-ondes
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.60 ISBN 978-2-8322-3378-8
IEC 60601-2-6 ®
Edition 2.1 2016-04
CONSOLIDATED VERSION
REDLINE VERSION
VERSION REDLINE
colour
inside
Medical electrical equipment –
Part 2-6: Particular requirements for the basic safety and essential performance
of microwave therapy equipment
Appareils électromédicaux –
Partie 2-6: Exigences particulières pour la sécurité de base et les performances
essentielles des appareils de thérapie à micro-ondes
– 2 – IEC 60601-2-6:2012+AMD1:2016 CSV
© IEC 2016
CONTENTS
FOREWORD. 3
INTRODUCTION . 6
201.1 Scope, object and related standards . 7
201.2 Normative references . 8
201.3 Terms and definitions . 8
201.4 General requirements . 9
201.5 General requirements for testing of ME EQUIPMENT . 9
201.6 Classification of ME EQUIPMENT and ME SYSTEMS . 9
201.7 ME EQUIPMENT identification, marking and documents . 10
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 . 12
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 . 15
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 disturbances – requirements and tests . 15
Annexes . 16
ANNEX C (informative) Guide to marking and labelling requirements for ME EQUIPMENT
and ME SYSTEMS . 17
Annex AA (informative) Particular guidance and rationale . 18
Index of defined terms used in this particular standard . 21
Table 201.101 – Additional ESSENTIAL PERFORMANCE requirements . 9
Table 201.C.101 – Marking on the outside of MICROWAVE THERAPY EQUIPMENT or its
parts . 17
Table 201.C.102 – Marking on the inside of MICROWAVE THERAPY EQUIPMENT or its parts . 17
© IEC 2016
INTERNATIONAL ELECTROTECHNICAL COMMISSION
____________
MEDICAL ELECTRICAL EQUIPMENT –
Part 2-6: Particular requirements for the basic safety and
essential performance of microwave therapy equipment
FOREWORD
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This consolidated version of the official IEC Standard and its amendment has been prepared
for user convenience.
IEC 60601-2-6 edition 2.1 contains the second edition (2012-04) [documents 62D/985/FDIS and
62D/1008/RVD] and its amendment 1 (2016-04) [documents 62D/1331/FDIS and 62D/1351/RVD].
In this Redline version, a vertical line in the margin shows where the technical content is
modified by amendment 1. Additions are in g
...
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