EN IEC 60601-2-2:2018/FprA1:2022

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

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
• Publication Date: 12-Sep-2024
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: CLC/TC 62 - Electrical equipment in medical practice
• Drafting Committee: IEC/SC 62D - IEC_SC_62D
• Current Stage: 6055 - Ratification Completed (DOR) - Publishing
• Start Date: 31-Jul-2024
• Completion Date: 31-Jul-2024
• 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: SIST EN IEC 60601-2-2:2018/kFprA1:2022 - 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: 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
• 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.

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

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.
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.
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.

SIST EN IEC 60601-2-2:2018/oprA1:2022
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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.
SIST EN IEC 60601-2-2:2018/oprA1:2022
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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.
th
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
SIST EN IEC 60601-2-2:2018/oprA1:2022
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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 published.
107 201.2 Normative references
108 Update the following normative references:
109 Replace “IEC 60601-1-2:2014” with “IEC 60601-1-2:2014 and IEC 60601-1-
110 2:2014/AMD1:2020”
111 Replace “IEC 60601-1-8:2006+AMD1:2012” with “IEC 60601-1-8:2006,
112 IEC 60601-1-8:2006/AMD1:2012 and IEC 60601-1-8:2006/AMD2:2020”
113 Replace CISPR 11:2015 with CISPR 11:2019
114 201.3.220 HIGH FREQUENCY
115 Add the following note:
116 Note 1 to entry: HIGH FREQUENCY (HF) and radio frequency (RF) are considered as equivalent in the context of this
117 standard as long as the frequency is within the range defined in this definition.
118 201.4.2.3.101 * Evaluating risk
119 Add the following text
120 Additionally, the impact on the heating under the NEUTRAL ELECTRODE shall be considered within
121 RISK ANALYSIS for any mode with a duty cycle above 45% according to its intended use even if
122 the HEATING FACTOR is below 30A²s in any 60s interval.
123 201.4.11 Power input
124 Replace the text of this paragraph with the following:
125 Replacement of first dash in compliance tests:
126 - The HF SURGICAL EQUIPMENT shall be operated in the manner (combination of operating
127 setting, load, etc.) which creates the greatest steady state input current. Input current
128 is measured and compared with the markings and the contents of the technical

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129 description.
132 201.7.8.1 Colours of indicator lights
134 With reference to table 2 in the general standard, the meaning of the following colours are
135 modified as follows:
136 Table 201.101 – Colours of indicator lights and their meaning
137 for HF SURGICAL EQUIPMENT
138 Amendment
Name On when Indicator light Alarm indicator Accompanied by Operator requirement
light sound
c,d
Warning Hazardous Red, flashing or - - Immediate response by the
situation not operator is required, for
example, a fault in the patient
circuit
e
Cutting mode Yellow, flashing - Yes -
or not
139 Addition
Name On when Indicator light Alarm indicator Accompanied by Operator requirement
light sound
e
Coagulation Blue, flashing or - Yes -
mode not
e
140 As defined in 201.12.4.2.101
142 201.7.9.2.2.101 Additional information in instructions for use
144 In the first sentence of paragraph c), add an ‘s’ to the word “instruction” because it is plural.
146 201.7.9.2.14 * Accessories, supplementary equipment, used material
147 Add new item:
148 k) the length of the ACCESSORY and its cord.
149 201.7.9.3.1 * General
150 Add the following note:
151 Note : The manufacturer can describe specific behaviour of the HF SURGICAL EQUIPMENT, e.g. short circuit protection
153 201.8.7.1. General requirements
155 Add the following note after the last sentence:
157 Note: This may require temporary internal modifications (e.g. Bridging of relay contacts) to be made to the HF
158 SURGICAL EQUIPMENT
160 201.8.7.3.101 Thermal effects of HF LEAKAGE CURRENT
162 2) for MONOPOLAR HF ISOLATED PATIENT CIRCUITS

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163 Replace the sentence beginning with “The HF SURGICAL EQUIPMENT is set up as shown in Figure
164 201.106,…” with the following:
165 The
...