SIST EN IEC 60601-2-2:2018/oprA1:2022

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

No scope available

Medizinische elektrische Geräte - Teil 2-2: Besondere Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale von Hochfrequenz-Chirurgiegeräten

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

Medicinska električna oprema - 2-2. del: Posebne zahteve za osnovno varnost in bistvene lastnosti visokofrekvenčne kirurške opreme in visokofrekvenčnega kirurškega pribora - Dopolnilo A1

General Information

• Status: Not Published
• Public Enquiry End Date: 30-Jun-2022
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: IEMO - Electrical equipment in medical practice
• Current Stage: 4020 - Public enquire (PE) (Adopted Project)
• Start Date: 22-Apr-2022
• Due Date: 09-Sep-2022
• Directive: 2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
• Mandate: M/575 - Medical devices in support of Regulation (EU) 2017/745 and in vitro diagnostic medical devices in support of Regulation (EU) 2017/746
• Ref Project: EN IEC 60601-2-2:2018/prA1:2022 - 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

RELATIONS

• Amends: SIST EN IEC 60601-2-2:2018 - 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)
• Effective Date: 01-Jun-2021

Standards Content (sample)

SLOVENSKI STANDARD
SIST EN IEC 60601-2-2:2018/oprA1:2022
01-junij-2022
Medicinska električna oprema - 2-2. del: Posebne zahteve za osnovno varnost in
bistvene lastnosti visokofrekvenčne kirurške opreme in visokofrekvenčnega
kirurškega pribora - Dopolnilo A1

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

Medizinische elektrische Geräte - Teil 2-2: Besondere Festlegungen für die Sicherheit

einschließlich der wesentlichen Leistungsmerkmale von Hochfrequenz-Chirurgiegeräten

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
Ta slovenski standard je istoveten z: EN IEC 60601-2-2:2018/prA1:2022
ICS:
11.040.30 Operacijski instrumenti in Surgical instruments and
materiali materials
SIST EN IEC 60601-2-2:2018/oprA1:2022 en

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN IEC 60601-2-2:2018/oprA1:2022
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SIST EN IEC 60601-2-2:2018/oprA1:2022
62D/1944/CDV
COMMITTEE DRAFT FOR VOTE (CDV)
PROJECT NUMBER:
IEC 60601-2-2/AMD1 ED6
DATE OF CIRCULATION: CLOSING DATE FOR VOTING:
2022-04-15 2022-07-08
SUPERSEDES DOCUMENTS:
62D/1861/CD, 62D/1902A/CC
IEC SC 62D : ELECTROMEDICAL EQUIPMENT
SECRETARIAT: SECRETARY:
United States of America Ms Ladan Bulookbashi
OF INTEREST TO THE FOLLOWING COMMITTEES: PROPOSED HORIZONTAL STANDARD:
Other TC/SCs are requested to indicate their interest, if any, in
this CDV to the secretary.
FUNCTIONS CONCERNED:
EMC ENVIRONMENT QUALITY ASSURANCE SAFETY

SUBMITTED FOR CENELEC PARALLEL VOTING NOT SUBMITTED FOR CENELEC PARALLEL VOTING

Attention IEC-CENELEC parallel voting
The attention of IEC National Committees, members of
CENELEC, is drawn to the fact that this Committee Draft for Vote
(CDV) is submitted for parallel voting.
The CENELEC members are invited to vote through the
CENELEC online voting system.

This document is still under study and subject to change. It should not be used for reference purposes.

Recipients of this document are invited to submit, with their comments, notification of any relevant patent rights of which they are

aware and to provide supporting documentation.
TITLE:

Amendment 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

PROPOSED STABILITY DATE: 2027
NOTE FROM TC/SC OFFICERS:

The 6th Edition of IEC 60601-2-2 was published in 2017. This amendment is intended to align the standard to IEC

60601-1:2005/AMD2:2020. Additional issues reported from the National Committees and other interested parties

since the publication in 2017 are addressed. National Committees are invited to submit votes and comments on the

amended parts at this stage.

Copyright © 2022 International Electrotechnical Commission, IEC. All rights reserved. It is permitted to download this

electronic file, to make a copy and to print out the content for the sole purpose of preparing National Committee positions. You

may not copy or "mirror" the file or printed version of the document, or any part of it, for any other purpose without permis sion

in writing from IEC.
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SIST EN IEC 60601-2-2:2018/oprA1:2022
62D/1944/CDV – 2 – IEC CDV 60601-2-2 AMD1 © IEC:2021
1 INTERNATIONAL ELECTROTECHNICAL COMMISSION
2 ____________
4 MEDICAL ELECTRICAL EQUIPMENT –
6 Part 2-2: Particular requirements for the basic safety and essential
7 performance of high frequency surgical equipment and high frequency
8 surgical accessories
10 AMENDMENT 1
13 FOREWORD

14 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising

15 all national electrotechnical committees (IEC National Committees). The object of IEC is to promote international

16 co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and

17 in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports,

18 Publicly Available Specifications (PAS) and Guides (hereafter referred to as “IEC Publication(s)”). Their

19 preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with

20 may participate in this preparatory work. International, governmental and non-governmental organizations liaising

21 with the IEC also participate in this preparation. IEC collaborates closely with the International Organization for

22 Standardization (ISO) in accordance with conditions determined by agreement between the two organizations.

23 2) The formal decisions or agreements of IEC on technical matters express, as nearly as possible, an international

24 consensus of opinion on the relevant subjects since each technical committee has representation fro m all

25 interested IEC National Committees.

26 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National

27 Committees in that sense. While all reasonable efforts are made to ensure that the technical content of IEC

28 Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any

29 misinterpretation by any end user.

30 4) In order to promote international uniformity, IEC National Committees undertake to apply IEC Publications

31 transparently to the maximum extent possible in their national and regional publications. Any divergence between

32 any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter.

33 5) IEC itself does not provide any attestation of conformity. Independent certification bodies provide conformity

34 assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any

35 services carried out by independent certification bodies.

36 6) All users should ensure that they have the latest edition of this publication.

37 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and

38 members of its technical committees and IEC National Committees for any personal injury, property damage or

39 other damage of any nature whatsoever, whether direct or indirect, or for costs (including legal fees) and

40 expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC

41 Publications.

42 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is

43 indispensable for the correct application of this publication.

44 9) Attention is drawn to the possibility that some of the elements of this document may be the subject of patent

45 rights. IEC shall not be held responsible for identifying any or all such patent rights.

47 Amendment 1 to IEC 60601-2-2:2017 has been prepared by subcommittee 62D: Electromedical

48 Equipment, of IEC technical committee 62: Electrical equipment in medical practice.

49 The text of this Amendment is based on the following documents:
Draft Report on voting
XX/XX/XXXX XX/XX/XXX

51 Full information on the voting for its approval can be found in the report on voting indicated in

52 the above table.
53 The language used for the development of this Amendment is English.
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SIST EN IEC 60601-2-2:2018/oprA1:2022
IEC CDV 60601-2-2 AMD1 © IEC:2021 – 3 – 62D/1944/CDV

54 This document was drafted in accordance with ISO/IEC Directives, Part 2, and developed in

55 accordance with ISO/IEC Directives, Part 1 and ISO/IEC Directives, IEC Supplement, available

56 at www.iec.ch/members_experts/refdocs. The main document types developed by IEC are

57 described in greater detail at www.iec.ch/standardsdev/publications/.

58 The committee has decided that the contents of this document will remain unchanged until the

59 stability date indicated on the IEC website under webstore.iec.ch in the data related to the

60 specific document. At this date, the document will be
61 • reconfirmed,
62 • withdrawn,
63 • replaced by a revised edition, or
64 • amended.
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SIST EN IEC 60601-2-2:2018/oprA1:2022
62D/1944/CDV – 4 – IEC CDV 60601-2-2 AMD1 © IEC:2021
66 INTRODUCTION TO THE AMENDMENT

67 The International Electrotechnical Commission (IEC) draws attention to the fact that it is claimed

68 that compliance with this document may involve the use of a patent. IEC takes no position

69 concerning the evidence, validity, and scope of this patent right.

70 The holder of this patent right has assured IEC that s/he is willing to negotiate licences under

71 reasonable and non-discriminatory terms and conditions with applicants throughout the world.

72 In this respect, the statement of the holder of this patent right is registered with IEC. Information

73 may be obtained from the patent database available at http://patents.iec.ch.

74 Attention is drawn to the possibility that some of the elements of this document may be the

75 subject of patent rights other than those in the patent database. IEC shall not be he ld

76 responsible for identifying any or all such patent rights.

77 The 6 Edition of IEC 60601-2-2 was published in 2017. This amendment is intended to align

78 the standard to IEC 60601-1:2005/AMD2:2020. Additionally, this amendment is intended to

79 address several issues reported from the national committees, including but not limited to:

80 • Requirement for including the length of an accessory in the instructions for use

81 • Clarification of test setup for HF LEAKAGE CURRENTS
82 • Considering modes with high DUTY CYCLES above 45% in the risk management

83 • Including text of the interpretation sheet 62D/1703/INF regarding the HIGH CURRENT

84 MODE to annex AA
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SIST EN IEC 60601-2-2:2018/oprA1:2022
IEC CDV 60601-2-2 AMD1 © IEC:2021 – 5 – 62D/1944/CDV
86 MEDICAL ELECTRICAL EQUIPMENT –
88 Part 2-2: Particular requirements for the basic safety and essential
89 performance of high frequency surgical equipment and high frequency
90 surgical accessories
92 AMENDMENT 1
95 201.1 Scope, object and related standards

96 In footnote 1 to the first sentence, replace “IEC 60601-1:2005/AMD1:2012” with “IEC 60601-

97 1:2005, IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020”
99 201.1.3 Collateral standards
100 Replace the second paragraph with:
101 IEC 60601-1-2:2014 and IEC 60601-1-2:2014/AMD1:2020 and IEC 60601-1-8:2006,

102 IEC 60601-1-8:2006/AMD1:2012 and IEC 60601-1-8:2006/AMD2, apply as modified in Clauses

103 202 and 208 respectively. IEC 60601-1-3, IEC 60601-1-10, IEC 60601-1-11 and

104 IEC 60601-1-12 do not apply. All other published collateral standards in the IEC 60601-1 series

105 apply as publis
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