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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 ריפוי הפועל בגלים קצרים 
Medical electrical equipment: Particular requirements for the basic safety and  
essential performance of short -wave therapy equipment  
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 תקן ישראלי ת"י 60601 חלק2.3 
אבהתשע"  ח – אוגוסט  2018  
טיוטה לגיליון תיקון מס'   1 
אוגוסט  2023 SI 60601  part 2.3 
August  2018 
Draft Amendment No. 1 
August  2023 
מסמך זה הוא הצעה בלבד
  
טיוטה לגיליון תיקון מס'   1  לתקן הישראלית"י   60601  חלק2.3   ( 2023  ) 
 
 גיליון תיקוןזה  הוכן ואושר על ידי  הוועדה הטכנית  5801    –  ציוד חשמלי לשימוש רפואי, בהרכב זה 
איגוד לשכות המסחר  -  אייל גרינבאום, אורנה שרון  
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  
 
כמו כן תר ם   להכנת  גיליון התיקון   דני אבן - חן .    
 
זיוה שלו ריכזה את עבודת הכנת  גיליון התיקון .  
 
 
 טיוטה   ל גיליון תיקון  מס'  1  לתקן הישראלית"י   60601  חלק2.3   ( 2023 ) 
 
 הודעה עלגיליון תיקון   
גיליון תיקון זה, למעט השינויים והתוספות הלאומיים המצוינים בו, 
זהה לגיליון התיקון של הנציבות הבין- לאומית לאלקטרוטכניקה  
IEC 60601 -2-3:2012/AMD2:  2022 -09 
גיליון תיקון זהמעדכן את   
התקן הישראלי ת"י  60601 חלק2.3 מאוגוסט2018  
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 לכניסה לתוקף.   
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  חלק2.3   ( 2023 ) 
 
 
1 הקדמהלגיליון התיקון הישראלי   
גיליון תיקון   ישראלי זה הוא  גיליון התיקון  של   הנציבות הבין - לאומית לאלקטרוטכניקה  
 IEC 60601 -2-3:2012/AMD2מספטמבר  2022, שאושר כגיליון תיקון ישראלי  בשינויים ובתוספות לאומיים .  
גיליון התיקון של הנציבות הבין - לאומית  לאלקטרוטכניקה מובא להלן בשפה האנגלית.  
שינויים   לחלק   העברי   של   התקן :  
בסוף ה חלק העברי של ה תקן יוסף:  
פירוט השינויים  והתוספות  הלאומיים   לסעיפי התקן הבין - לאומי  
201.2 . Normative references 
 במקוםאחד   התק נים   הבין - לאומי ים   המאוזכר ים   בתקן  והמפורט ים   בסעיף זה חל תק ן   ישראלי,   
כמפורט להלן:  
התקן הבין - לאומי המאוזכר  התקן הישראלי  ה חל במקומו  
IEC 60601 -1:2005  
IEC 60601 -1:2005/AMD1:2012  
IEC 60601 -1:2005/AMD2:2020  ת"י60601  חלק1   –  ציוד חשמלי לשימוש רפואי 
דרישות כלליות לבטיחות בסיסית ולביצועים חיוניים  
  
IEC 60601 -2-3 
Edition  3.0 2022 -09 
INTERNATIONAL  
STANDARD  
NORME  
INTERNATIONALE  
Medical electrical equipment –  
Part 2-3: Particular requirements for the basic safety and essential performance 
of short -wave therapy equipment   
 
Appareils électromédicaux –  Partie 2-3: Exigences particulières pour la sécurité de base et les performances 
essentielles des appareils de thérapie à ondes courtes   
IEC 60601 -2-3:2012-04/AMD 2:2022 -09(en-fr) 
AMENDMENT  2 
AMENDEMENT 2  
 
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 IEC 60601 -2-3 
Edition  3.0 2022 -09 
INTERNATIONAL  
STANDARD  
NORME  
INTERNATIONALE  
Medical electrical equipment – 
Part 2-3: Particular requirements for the basic safety and essential performance 
of short -wave therapy equipment   
 
Appareils électromédicaux –   Partie 2-3: Exigences particulières pour la sécurité de base et les performances 
essentielles des appareils de thérapie à ondes cour tes  
 
INTERNATIONAL  
ELECTROTECHNICAL  
COMMISSION  
COMMISSION  
ELECTROTECHNIQUE  
INTERNATIONALE   
ICS 11.040.60   
ISBN 978-2-8322 -5663 -3 
   
  
® 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 2 
AMENDEMENT 2 
   – 2 – IEC 60601 -2-3:2012/AMD2:202 2 
  © IEC 202 2 
INTERNATIONAL ELECTROTECHNICAL COMMISSION  
____________  
 
MEDICAL ELECTRICAL EQUIPMENT –  
 
Part 2 -3: Particular requirements for the basic safety and  
essential performance of short -wave therapy equipment  
 
AMENDMENT 2  
 
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  2 to IEC  60601-2- 3:2012 has been prepared by subcommittee 62D: Electromedical 
equipment, of IEC technical committee 62: Electrical equipment in medical practice.  
The text of this Amendment is based  on the following documents:  
Draft  Report on voting  
62D/1846/ CDV  62D/1959/ RVC 
 
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 -2-3:2012/AMD2:202 2 – 3 –  
© IEC 202 2   
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/standardsdev/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.  
NOTE  The attention of users of this document is drawn to the fact that equipment manufacturers and testing 
organizations may need a transitional period following publication of a new, amended or revised IEC or 
ISO publication in which to make products in accordance with the new requirements and to equip themselves for 
conducting new or revised tests.  It is the recommendation of the committee that the content of this publication be 
adopted for mandatory implementation nationally not earlier than 3 years from the date of publication.  
 
___________ 
 
INTRODUCTION to Amendment  2 
At the October 2019 meeting of IEC SC 62D in Shanghai, China, the subcommittee discussed 
the need for administrative/technical changes to most 62D standards after completion of the 
amendment projects within the IEC  60601 -1 series.  Those projects were all completed and the 
amendments published in 2020.  
The full list of IEC SC 62D documents that will be amended or revised may be found within the 
IEC document 62D/1 792/DC. The results and comments on the DC may be found within 
62D1808/INF. The review report for this amendment is 62D/1829 /RR. 
___________ 
 
201.1 Scope, object and related standards  
Replace the existing text of footnote 1, modified by Amendment 1,  with the following : 
The general standard is IEC  60601 -1:2005 , IEC 60601 -1:2005/AMD1:2012 and 
IEC 60601 -1:2005/AMD2:2020, Medical electrical equipment – Part 1: General requirements 
for basic safety and essential performance . 
 201.1.3 Collateral standards  
Replace, i n the second paragraph, the first sentence with  the following : 
IEC 60601 -1-3 and IEC  60601 -1-12 do not apply.  
  – 4 – IEC 60601 -2-3:2012/AMD2:202 2 
  © IEC 202 2 
201.2 Normative references  
Replace the existing text with  the following: 
Clause 2 of the general standard applies, except as follows : 
Addition:  
IEC 60601 -1:2005, Medical electrical equipment – Part 1: General requirements for basic safety 
and essen tial performance  
IEC 60601 -1:2005/AMD 1:2012 
IEC 60601 -1:2005/AMD 2:2020 
IEC TR 60878:2015, Graphical symbols for electrical equipment in medical practice 
 
201.3 Terms and definitions  
Replace, i n the first sentence , modified by Amendment 1 , “IEC 60601 -1” with 
“IEC 60601 -1:2005, IEC 60601 ‑1:2005/AMD1:2012 and IEC 60601 -1:2005 /AMD2:2020”.  
 
Index of defined terms used in this particular standard  
Replace the following entries, modified by Amendment 1, as follows:  
BASIC SAFETY  ....................................................................................... IEC 60601 -1:2005, 3.10  
ENCLOSURE  .......................................................................................... IEC 60601 -1:2005, 3.26  
ESSENTIAL PERFORMANCE .............. IEC 60601 -1:2005 and IEC 60601- 1:2005/AMD 1:2012, 3.27  
HAZARD ......................................... IEC 60601 -1:2005 and IEC 60601- 1:2005/AMD2:2020 , 3.39  
LEAKAGE CURRENT  ................................................................................ IEC 60601 -1:2005, 3.47  
MAINS VOLTAGE  .................................................................................... IEC 60601 -1:2005, 3.54  
MANUFACTURER  ............................. IEC 60601 -1:2005 and IEC 60601- 1:2005/AMD2:2020 , 3.55  
MEDICAL ELECTRICAL EQUIPMENT (ME EQUIPMENT ) ................................... IEC 60601 -1:2005, 3.63  
MEDICAL ELECTRICAL SYSTEM (ME SYSTEM ) ............................................. IEC 60601 -1:2005, 3.64  
OPERATOR  ........................................................................................... IEC 60601 -1:2005, 3.73  
PATIENT  ........................................ IEC 60601 -1:2005 and IEC 60601- 1:2005/AMD1:2012 , 3.76  
PATIENT AUXILIARY CURRENT  ................................................................. IEC 60601 -1:2005, 3.77  
PATIENT LEAKAGE CURRENT  ................................................................... IEC 60601 -1:2005, 3.80  
RATED  ................................................................................................. IEC 60601 -1:2005, 3.97  
RISK ........................................... IEC 60601 -1:2005 and IEC 60601- 1:2005/AMD2:2020 , 3.102  
SERVICE PERSONNEL  ........................................................................... IEC 60601 -1:2005, 3.113  
 
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