 
 
  מכון התקנים הישראלי 
The Standards Institution of Israel 
  
רח' חיים לבנון42, תל-אביב  69977 01, טל' 03-6465154, פקס03-6412762, www.sii.org.il    
  
 
 
 
 
 
 
 
 
 
 
 
 
ציוד חשמלי לשימוש רפואי: דרישות מיוחדות לבטיחות בסיסית
ולביצועים חיוניים של ציוד לניתוח הפועל בתדר גבוה 
ושל אבזרים לניתוח הפועלים בתדר גבוה  
 
Medical electrical equipment: Particular requirements for  the basic safety  
and essential performance of high frequency surgical equipment  
and high frequency surgical accessories  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 תקן ישראלי ת"י 60601 חלק2.2 
תמוז התשע" ח –  יולי  2018  
טיוטה לגיליון תיקון מס'   1 
אוגוסט  2023 SI 60601  part 2.2 
July 2018 
Draft Amendment No. 1 
August 2023 
מסמך זה הוא הצעה בלבד
  
טיוטה לגיליון תיקון מס'   1  לתקן הישראלית"י   60601  חלק2.2   ( 2023  ) 
 
 גיליון תיקוןזה הוכן   ואושר  על ידי הוועדה הטכנית  5801    –  ציוד חשמלי לשימוש רפואי, בהרכב זה 
איגוד לשכות המסחר  -  יואב אסולין  
המועצה הישראלית לצרכנות  -  מיכאל שיזף  
מינוי אישי  -  ולנטין ויינטראוב, יוסי פרי פז  
מינוי אישי  –   מעבדה  -  אירנה אנטונוב  
משרד הבריאות  -  אלכסנדר וילנסקי (יו"ר)  
משרד הכלכלה והתעשייה  -  שלומי אביסרור  
רשות ההסתדרות לצרכנות  -  גבריאל זרוק  
 
כמו כן תרם להכנת גיליון התיקון   דני אבן - חן.   
 
זיוה שלו ריכזה את עבודת הכנת  גיליון התיקון .  
 
 
 טיוטה   ל גיליון תיקון  מס'  1  לתקן הישראלית"י   60601  חלק2.2   ( 2023 ) 
 
 הודעה עלגיליון תיקון   
גיליון תיקון זה, למעט השינויים והתוספות הלאומיים המצוינים בו, 
זהה לגיליון התיקון של הנציבות הבין- לאומית לאלקטרוטכניקה  
IEC 60601 -2-2:2017/AMD1:2023 -02 
גיליון תיקון זהמעדכן את   
התקן הישראלי ת"י  60601 חלק2.2 מיולי2018  
עדכניות התקן 
התקנים הישראליים עומדים לבדיקה מזמן לזמן, ולפחות אחת לחמש שנים, כדי להתאימם להתפתחות המדע והטכנולוגיה.  
המשתמשים בתקנים יוודאו שבידיהם המהדורה המעודכנת של התקן על גיליונות התיקון שלו.  
מסמך המתפרסם ברשומות כגיליון תיקון, יכול להיות גיליון תיקון נפרד או תיקון המשולב בתקן.  
תוקף התקן 
תקן ישראלי על עדכוניו נכנס לתוקף החל ממועד פרסומו ברשומות.  
יש לבדוק אם התקן רשמי או אם חלקים ממנו רשמיים. תקן רשמי או גיליון תיקון רשמי (במלואם או בחלקם) נכנסים לתוקף  
60 יום מפרסום ההודעה ברשומות, אלא אם בהודעה נקבע מועד מאוחר יותר לכניסהלתוקף.   
סימון בתו תקן 
כל המייצר מוצר, המתאים לדרישות התקנים הישראליים החלים עליו,  
רשאי, לפי היתר ממכון התקנים הישראלי, לסמנו בתו תקן:  
 
זכויות יוצרים 
© אין לצלם, להעתיק או לפרסם, בכל אמצעי שהוא, תקן זה או קטעים ממנו, ללא רשות מראש ובכתב ממכון התקנים הישראלי 
 
 
 
 
 
 
 
 
 
 
 
 
  
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טיוטה לגיליון תיקון מס'   1  לתקן הישראלית"י   60601  חלק2.2   ( 2023 ) 
 
 
1 הקדמהלגיליון התיקון הישראלי   
גיליון תיקון   ישראלי זה הוא  גיליון התיקון  של   הנציבות הבין - לאומית לאלקטרוטכניקה  
 IEC 60601 -2-2:201 7/AMD 1מפברוא  ר   2023   ,שאושר כגיליון תיקון ישראלי  בשינויים ובתוספות לאומיים .  
גיליון התיקון של הנציבות הבין - לאומית לאלקטרוטכניקה מובא להלן בשפה האנגלית.  
גיליון תיקון ישראלי זה מתקן גם את התקן הישראלי ת"י  60601  חלק2.2  מיולי2018 . 
שינויים  לחלק   העברי   של   התקן :  
עמוד   השער  
בכותרת   העליונה   של עמוד השער ,   בשורה השנייה, המילים " IEC 60601 -2-2 – Edition 6.0: 2017 -03" יושמטו 
 
עמוד   ההודעות   של   התקן  
הודעה על מידת התאמת התקן הישראלי לתקנים או למסמכים זרים   ( ראו  ב תחילת  עמוד   ההודעות   של   התקן )  
המשפט הראשון  ב הודעה , " תקן   ישראלי   זה   זהה   לתקן   של   הנציבות   הבין - לאומית  לאלקטרוטכניקה ",   י ושמט,  
ובמקומ ו   ייכתב:  
תקן   ישראלי   זה , למעט השינויים והתוספות הלאומיים המצוינים בו,   זהה   לתקן   של   הנציבות   הבין - לאומית  
לאלקטרוטכניקה  
 
הקדמה לתקן הישראלי  
- בשור ה   השנייה ,  המילים   "שאושר  כלשונו   כתקן   ישראלי "  יושמט ו ,  ו במקומ ן   ייכתב:    
שאושר   כתקן ישראלי בשינויים ובתוספות לאומיים.  
- בפסקה   השנייה , בפירוט רכיבי התקן,   לאחר התבליט הראשון יוסף:    
- פירוט השינויים והתוספות הלאומיים לסעיפי התקן  הבין - לאומי   (בעברית)  
 
חלות התקן ומטרתו   (תרגום סעיף  201.1.1   –  חלות וסעיף201.1.2   –  מטרה של התקןהבין  - לאומי)  
הערת שוליים ( 1 ) 
השורה השלישית  בהערה,  "השינויים והתוספות הלאומיים   אינם רלוונטיים לתקן ישראלי זה   
(ת"י  60601  חלק2.2 ) "  תושמט  .  
 טיוטה לגיליון תיקוןמס'   1  לתקן הישראלית"י   60601  חלק2 .2   ( 2023 ) 
 
 
 
2  -  בסוף החלק העברי של התקן יוסף 
פירוט השינויים והתוספות  הלאומיים   לסעיפי  התקן  ה בין - לאומי  
בכל מקום בתקן  הבין - לאומי שבו מאוזכרים התקנים הבין - לאומיים המפורטים בטבלה שלהלן, חלים לחלופין  
תקנים ישראליים בהתאמה, כמפורט להלן:  
הערת הבהרה:   המשמעות היא שניתן לעמוד בתקן הבין - לאומי המאוזכר, או לחלופין בתקן הישראלי המאוזכר, בהתאמה.  
התקן  ה בין - לאומי   ה מאוזכר  התקן  הישראלי   החל   לחלופין  
IEC 60601 -1-2:2014  
IEC 60601 -1-2:2014/AMD1:2020  ת"י60601  חלק1.2   ( 2021  ) -  ציוד חשמלי לשימוש רפואי 
דרישות כלליות לבטיחות בסיסית ולביצועים חיוניים  –   תקן נִלווה:   
הפרעות   אלקטרומגנטי ו ת  –   דרישות ובדיקות  
IEC 60601 -1-8:2006  
IEC 60601 -1-8:2006/AMD1:2012  
IEC 60601 -1-8:2006/AMD2:2020  ת"י60601  חלק1.8   [ 2015  לרבות ג"ת1   ( 2021 ) ]   -  ציוד חשמלי
לשימוש רפואי: דרישות כלליות לבטיחות בסיסית ולביצועים  
חיוניים  –   תקן נלווה: דרישות כלליות, בדיקות והנחיות עבור  
מערכות אזעקה בציוד רפואי - חשמלי ובמער כות רפואיות - חשמליות  
CISPR 11:2015  
CISPR 11:2015/AMD1:2016  
CISPR 11:2015/AMD2:2019  ת"י  961  חלק11   [ 2016  לרבות ג"ת1   ( 2020 ) ]   -  תאימות
אלקטרומגנטית: ציוד תעשייתי, מדעי ורפואי  –   אופייני הפרעות  
בתדר רדיו  –   גבולות ושיטות מדידה  
 
201.2 . Normative references  
 לסעיף יוסף 
 תקנים ישראליים  
ת"י  60601  חלק1.2   ( 2021 )  - ציוד חשמלי לשימוש רפואי: דרישות כלליות לבטיחות בסיסית
ולביצועים חיוניים  –   תקן נִלווה: הפרעות אלקטרומגנטיות  –   
דרישות ובדיקות  
ת"י  60601  חלק1.8   [ 2015  
לרבות ג"ת1   ( 2021 ) ]    - ציוד חשמלי לשימוש רפואי: דרישות כלליות לבטיחות בסיסית
ולביצועים חיוניים  –   תקן נלווה: דרישות כלליות, בדיקות והנחיות  
עבור מערכות אזעקה בציוד רפואי - חשמלי ובמערכות   
רפואיות - חשמליות  
ת"י  961  חלק11   [ 2016  
לרבות ג"ת1   ( 2020 ) ]  - תאימות אלקטרומגנטית: ציוד תעשייתימדעי ורפואי    –   
אופייני  הפרעות בתדר רדיו  –   גבולות ושיטות מדידה  
  
IEC 60601-2-2 
Edition  6.0 2023-02 
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  
 
IEC 60601 -2-2:2017-03/AMD 1:2023-02(en-fr) 
  
  
® 
 
AMENDMENT 1 
AMENDEMENT 1 
   
 
  
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 IEC 60601 -2-2 
Edition  6.0 2023-02 
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  
INTERNATIONALE   
ICS 11.040.30  
  
ISBN 978-2-8322 -6466 -9 
   
  
® Registered trademark of the International Electrotechnical Commission  
 Marque déposée de la Commission Electrotechnique Internationale  
® 
 
 Warning! Make sure that you obtained this publication from an authorized distributor.  
 Attention! Veuillez vous assure r que vous avez obtenu cette publication via un distributeur agréé.  AMENDMENT 1 
AMENDEMENT 1 
   – 2 – IEC 60601 -2-2:2017/ AMD1 :2023 
© IEC 202 3 
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 
 
AMENDMENT 1  
 
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 document may be the subject of patent rights. IEC shall not be held responsible for identifying any or all such patent rights.  
Amendment  1 to IEC 60601 -2-2:2017 has been prepared by subcommittee 62D: Particular 
medical equipment, software, and systems , of IEC technical committee 62: Medical equipment, 
software, and systems . 
The text of this Amendment is based  on the following documents:  
Draft  Report on voting  
62D/2010/FDIS  62D/2021/RVD  
 
Full information on the voting for its approval can be found in the report on voting indicated in the above table.  
The language used for the development of this Amendment is English . IEC 60601 -2-2:2017/ AMD1 :2023 – 3 –  
© IEC 202 3 
This document was drafted in accordance with ISO/IEC Directives, Part  2, and developed in 
accordance with ISO/IEC Directives, Part  1 and ISO/IEC Directives, IEC Supplement, available 
at www.iec.ch/members_experts/refdocs . The main document types developed by IEC are 
described in greater detail at  www.iec.ch/publications/ . 
The committee has decided that the contents of this document will remain unchanged until the 
stability date indicated on the IEC website under  webstore.iec.ch in the data related to the 
specific document . At this date, the document will be  
• reconfirmed,  
• withdrawn,  
• replaced by a revised edition, or  
• amended.  
 
___________ 
 
INTRODUC TION  to Amendment 1  
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 . Additionally, this amendment is intended to 
address several issues reported from the national committees, including but not limited to:  
• requirement for including the length of an accessory in the instructions for use ; 
• clarification of test setup for HF LEAKAGE CURRENTS ; 
• considering modes with high DUTY CYCLES  above 45  % in the risk management ;  
• including text of the interpretation sheet 62D/1703/INF regarding the HIGH CURRENT MODE  
to Annex AA. 
 
201.1 Scope, object and related standards  
Replace, in footnote 1 to the first sentence,  "IEC 60601 -1:2005/AMD1:2012 " with 
"IEC 60601 -1:2005, IEC 60601 -1:2005/AMD1:2012 and IEC 60601 -1:2005/AMD2:2020 ". 
201.1.3 Collateral standards  
Replace the existing second paragraph  with the following : 
IEC 60601 -1-2:2014  and IEC 60601 -1-2:2014/ AMD1:2020 and IEC 60601 -1-8:2006 , 
IEC 60601 -1-8:2006 /AMD1:2012 and IEC  60601-1- 8:2006/AMD2 :2020, apply as modified in 
Clauses 202 and 208 respectively. IEC  60601 -1-3, IEC 60601 -1-10, IEC 60601-1- 11 and 
IEC 60601 -1-12 do not apply. All other published collateral standards in the IEC  60601 -1 series 
apply as p ublished.   – 4 – IEC 60601 -2-2:2017/ AMD1 :2023 
© IEC 202 3 
201.2 Normative references  
Replace the existing reference to IEC 60601 -1-2:2014 with the following:  
IEC 60601 -1-2:2014 , Medical electrical equipment – Part 1- 2: General requirements for basic 
safety and essential performance – Collateral Standard : Electromagnetic disturbances – 
Requirements and tests   
IEC 60601 -1-2:2014/AMD1:2020 
Replace the existing reference to IEC 60601 -1-8:2006 with the following:  
IEC 60601-1-8:2006 , Medical electrical equipment – Part 1- 8: General 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  
IEC 60601 -1-8:2006/AMD1:2012   
IEC 60601 -1-8:2006 /AMD2:2020 
Delete the existing references to IEC 61000 -4-3:2006 and IEC 6100-4- 6:2013 . 
Replace the existing reference to CISPR 11:2015 with the following:  
CISPR 11:2015,  Industrial, scientific and medical equipment  – Radio -frequency disturbance 
characteristics – Limits and methods of measurement   
CISPR  11:2015/AMD1:2016  
CISPR  11:2015/AMD2:2019 
201.3.220   
* HIGH FREQUENCY  
Add, after the existing definition,  the following new note:  
Note  1 to entry:  H IGH FREQ UENCY  (HF) and radio frequency (RF) are considered as equivalent in the context of this 
document as long as the frequency is within the range defined in this definition.  
201.4.2.3.101  * Evaluating risk  
Add, at the end of the existing subclause,  the following  new text: 
Additionally, the impact on the heating under the NEUTRAL ELECTRODE  shall be considered within 
RISK ANALYSIS  for any mode with a duty cycle above 45 % according to its  intended use  even if 
the HEATING FACTOR  is below 30  A2s in any 60  s interval.  
201.4.11  Power input  
Replace the text of this paragraph with the following: 
Replacement of first dash in compliance tests:  
– The HF SURGICAL EQUIPMENT  shall be operated in the manner (combination of operating 
setting, load, etc.) which cre ates the greatest steady state input current. Input current is 
measured and compared with the markings and the contents of the technical description.  IEC 60601 -2-2:2017/ AMD1 :2023 – 5 –  
© IEC 202 3 
Table 201.101 – Colours of indicator lights and their meaning for  HF SURGICAL EQUIPMENT  
Replace the existi ng table with the following new table : 
Table  201.101 – Colours of indicator lights and their meaning  
for HF SURGICAL EQUIPMENT  
Name  On when  Indicator 
lighta Alarm 
indicator light  Accompanied 
by sound  Operator 
requirement  
Warning b Hazardous 
situation  Red, flashing or not  - - 
c Immediate response 
by the operator is 
required, for example, 
a fault in the patient 
circuit  
CUTTING  mode  C UTTING  
activation  Yellow, flashing or not  - Yes 
d - 
COAGULATION  
mode  COAGULATION  
activation  Blue, flashing or not  - Yes 
d - 
Ready for use  M E EQUIPMENT 
is ready for use  Green  - - - 
Other  Situations other  than that 
of red,  yellow , 
blue or green Any colour other  than red, 
yellow,  blue or 
green  - - - 
a  These indicator lights are INFORMATION SIGNALS and IEC 60601 -1-8 requires that they be perceived as different  
than visual ALARM SIGNALS . 
b  Such warnings and cautions are frequently accompanied by a SAFETY SIGN . 
c  Sound may be utilized, but IEC  60601 -1-8 requires that it be perceived as different than auditory ALARM 
SIGNALS . 
d  As defined in 201.12.4.2.101.  
 
201.7.9.2.2.101 Additional information in instructions for use  
Replace, i n the first sentence of item c), "instruction" with “ instructions ”. 
201.7.9.2.14 * ACCESSORIES , supplementary equipment, used material  
Add, before NOTE 101, the following new item:  
k) * the length of the HF SURGICAL  ACCESSORY .  
201.7.9.3.1  * General  
Add, at the end of the existing subclause,  the following  new note:  
NOTE  101 The manufacturer can describe the specific behaviour of the HF SURGICAL EQUIPMENT , e.g. short circuit 
protection. 
201.8.7.1  * General requirements 
Add, after the last sentence,  the followi ng new note:  
NOTE  Temporary internal modifications to the HF SURGICAL EQUIPMENT  can be used  (e.g. b ridging of relay contacts ) 
to ensure the correct measurement of low -frequency LEAKAGE CURRENTS .   – 6 – IEC 60601 -2-2:2017/ AMD1 :2023 
© IEC 202 3 
201.8.7.3.101  Thermal effects of HF LEAKAGE CURRENT  
Replace, under item 2) for  MONOPOLAR HF ISOLATED PATIENT CIRCUITS , the sentence beginning 
with "The HF SURGICAL EQUIPMENT  is set up as shown in Figure 201.106,… " with the following:  
The HF SURGICAL EQUIPMENT is set up as shown in Figure 201.106. Each electrode is tested with 
the output first being unloaded and then repeated with the output loaded at the RATED LOAD .  
Replace, in item 3),  the sentence beginning with " The test is conducted with the output …" in 
the fourth paragraph with the following:  
The test is conducted with the output first being unloaded or with the highest load resistance 
that produces an HF output and then repeated with the output loaded at the RATED LOAD.  
 
Figure 201.107 – Measurement of HF  LEAKAGE CURRENT  from a BIPOLAR ACCESSO RY 
Replace the existing  figure with the following  new figure: 
Dimensions in meters  
 
Key 
1 SUPPLY MAINS  
2 Table, made of insulating material  
3 HF SURGICAL EQUIPMENT  
5 NEUTRAL ELECTRODE , metallic or in contact with metal foil of the same size 
7 Measuring resistance, 200 Ω  
8 HF current meter  
9 Earthed conductive plane  
10 Activated BIPOLAR  ACCESSORY  
11 Load resistance as required with HF power measuring device  
Figure  201.107 – Measurement of HF  LEAKAGE CURRENT  from a BIPOLAR ACCESSORY  
IEC 60601 -2-2:2017/ AMD1 :2023 – 7 –  
© IEC 202 3 
201.8.8.3.102  * ACTIVE ACCESSORY HF  leakage 
Replace the  existing sentence starting with  "The insulation applied to ACTIVE ACCESSORIES …” 
with “The insulation applied to ACTIVE ACCESSORIES , including ACTIVE ELECTRODE INSULATION  and 
ACTIVE HANDLES , but excluding ACTIVE CONNECTORS , shall limit HF LEAKAGE CURRENT  passing 
through the external surface of the insulation to less than Ileakage.” 
Add, at the end of item a), the following new note:  
NOTE  In this paragraph, ‘ d’ is the outer diameter of an insulation with a circular cross section. It is  noted that the 
current formula can only be used for ACTIVE ACCESSORIES with circular cross section. For an ACTIVE ACCESSORY  with 
a non -circular cross section, a value  ‘d’ is calculated from the circumference ‘ c’ of the original shape. In this case, 
the value d corresponds to the circumference divided by π . 
d = c  /  π 
201.12.4.3.101  * Output reduction means  
Delete the existing asterisk in the subclause title.  
Replace the first sentence of this subclause with the following:  
Except as provided for in 201.7.9.2.2.101 a) item 7, and 201.7.9.3.1. – 5th dash, for each HF 
SURGICAL MODE , HF SURGICAL EQUIPMENT shall incorporate means to enable the output power to 
be reduced to not more than 5  % of the RATED OUTPUT POWER or 10 W, whichever is smaller 
(see also 201.12.1.102).  
201.12.4.4.102  * Output power during simultaneous activation  
Delete the existing introdu ctory  sentence in the compliance statement : "For HF SURGICAL 
EQUIPMENT  as defined in 201.12.2 c) ". 
Add, before the sentence starting with " The output under test is activated at 20  %", the following  
new sentence “ For HF SURGICAL EQUIPMENT  as defined in 201. 12.2 c) 1) :”. 
Add, before the sentence starting with " The output under test is activated at 50  %", the following  
new sentence  “For HF SURGICAL EQUIPMENT  as defined in 201.12.2 c) 2) :”. 
202 * ELECTROMAGNETIC DISTURBANCES  – Requirements and tests 
Replace “ IEC 60601-1- 2:2014  applies ” with “ IEC 60601 -1-2:2014 and 
IEC 60601 -1-2:2014/AMD1:2020 apply ”. 
202.2 Normative references  
Replace the existing reference  to "IEC 60601-2- 2:2016" with "IEC 60601 -2-2:2017  and 
IEC 60601 -2-2:2017/ AMD1: 2023 ". 
202.3 Terms and definitions  
Replace the existing reference  to "IEC 60601-2- 2:2016" with "IEC 60601 -2-2:2017  and 
IEC 60601 -2-2:2017/ AMD1: 2023". 
202.101  Index of defined terms  
Replace the existing reference to " IEC 60601-2- 2:2016" with "IEC 60601 -2-2:2017  and 
IE
C 60601 -2-2:2017/ AMD1: 2023".   – 8 – IEC 60601 -2-2:2017/ AMD1 :2023 
© IEC 202 3 
208 General requirements, tests and guidance for alarm systems in medical 
electrical equipment  and medical electrical systems  
Replace "IEC 60601-1-8 :2006 applies " with "IEC 60601 -1-8:2006 , 
IEC 60601 -1-8:2006 /AMD1:2012 and IEC 60601 -1-8:2006 /AMD2:2020 apply ". 
Definition 201.3.219  – HIGH CURRENT MODE   
Add, after the existing text, the following new text : 
The definition of HIGH CURRENT MODE  is being misinterpreted with the effect that conventional 
HF SURGICAL EQUIPMENT  used for many years with compatible, conventional NEUTRAL 
ELECTRODES  without incidents are now erroneously declared as HIGH CURRENT MODE  devices. 
This is not the intention of the document . 
Users of the document  should understand that  
1) The load resistances specified in 201.7.9.3 and 201.12.1 do not define the INTENDED 
USE. The INTENDED USE  is defined by the MANUFACTURER  according to IEC  60601 -1:2005, 
IEC 60601 -1:2005/AMD1: 2012 and IEC 60601 -1:2005/AMD2:2020, 3.44.  
2) The MAXIMUM OUTPUT CURRENT  is the RMS current at the lowest relevant impedance 
determined by the MANUFACTURER  ignoring transients of less than 1 s when the device 
is operated according to the instructions for use.  
3) The document  requires that the MANUFACTURER  performs a RISK ANALYSIS  to review 
situations and reasonably foreseeable misuse that could result in current levels higher 
than the MAXIMUM OUTPUT CURRENT . 
The HEATING FACTOR  is calculated according t o 201.3.218. The HEATING FACTOR  is used to 
determine if a generator contains a HIGH CURRENT MODE  or not according to 201.3.219.  
Subclause 201.4. 2.3.101  – Evaluating  RISK 
Add, after the existing text, the following new text : 
The requirements for conventional NEUTRAL ELECTRODES  are based on data with a maximum 
duty cycle of 45  % (see rationale for 201.15.101.5). For modes that are used with higher duty 
cycles according to their intended use, this is addressed in risk management . 
Subclause 201.7.9.2.14 – ACCESSORIES , supplementary equipment, used material  
Add, after the existing text of S ubclause 201.7.9.2.14 j) , the following new item:  
Subclause 201.7.9.2.14 k)  
HF SURGICAL ACCESSORIES  act as antennas from an EMC point of view, so the user needs the 
length to ensure length compatibility between the HF SURGICAL EQUIPMENT  and the accessory.  
Subclause 201.8.8.3.101 – A CTIVE ACCESSORY insulation  
Replace the first sentence of the  existing  note with the following:  
This subclause was completely redrafted in the 5th Edition of this document to cover only dielectric strength of the 
various parts of ACTIVE ACCESSORY  insulation, independent from any particular HF SURGICAL EQUIPMENT . 
Subclause 20 1.12.4.3.101 – Output reduction means  
Delete the existing title and text.  IEC 60601 -2-2:2017/ AMD1 :2023 – 9 –  
© IEC 202 3 
Clause 202 – ELECTROMAGNETIC DISTURBANCES  – Requirements and tests  
Replace, in the fourth existing paragraph,  the first sentence with “During the immunity tests, t he 
MANUFACTURER will need  to specify how compliance to the standard is checked. ” 
Add, at the end of the existing subclause,  the following  new text:  
HF SURGICAL EQUIPMENT  is evaluated regarding EMC utilizing ACTIVE ACCESSORIES  that represent 
the least favourable configuration according to IEC  60601 -1-2. This configuration is c onsidered 
when determining the maximum permissible length of  accessories (see 201.7.9.2.2.101 i)).  The 
relevant length is for example the fully extended length between the ACTIVE CONNECTOR  and the 
distal end of the ACTIVE ELECTRODE . 
The MANUFACTURER  may choose not to re- evaluate EMC , if previously completed EMC testing 
can be shown to be applicable  by objective evidence for the configuration. 
HF SURGICAL ACCESSORIES , including ASSOCIATED EQUIPMENT , that include active electronic 
circuits  should be evaluated for  EMC.  
Ensuring compatibility between HF SURGICAL EQUIPMENT  and HF SURGICAL ACCESSOR IES is an 
OPERATOR  responsibility.  
 
Bibliography  
Add the  following new references [19] to [22] as follows:  
[19] IEC 60601-1- 3, Medical electrical equipment  – Part 1- 3: General requirements for basic 
safety and essential performance – Collateral Standard: Radiation protection in diagnostic 
X-ray equipment  
[20] IEC 60601-1- 10, Medical electrical equipment  – Part 1 -10: General requirements for basic 
safety and essential performance – Collateral Standard: Requirements for the 
development of physiologic closed -loop controllers  
[21] IEC 60601-1- 11, Medical electrical equipment  – Part 1 -11: General requirements for basic 
safety and essential performance – Collateral Standard: Requirements for medical 
electrical equipment and medical electrical systems used in the home healthcare 
environment  
[22] IEC 6060 1-1-12, Medical electrical equipment  – Part 1 -12: General requirements for basic 
safety and essential performance – Collateral Standard: Requirements for medical 
electrical equipment and medical electrical systems intended for use in the emergency medical services environment  
 
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