Draft of Israeli Standard SI 60601 part 2.2 SI 60601 part 2.2 
November 2008 2008 
 ICS Code 11.040.55 
 11.050.60 
 
 
    
 
Medical electrical equipment: Particular  requirements for the safety of  
high frequency surgical equipment 
 
     
This document is a re commendation only 
 
    
[logo] The Standards Institution of Israel 
42 Haim Levanon St., Tel Aviv 69977, Tel: 03-6465154, Fax: 03- 6412762, www.sii.org.il 
 mk/mk/mk            31243/          10/11/08  Draft of SI 60601 part 2.2 (2008) 
 This Standard was prepared by the following panel of experts: 
Danny Even-Chen, Irena Antonov, Alexander Vilensky (c hair), Uri Cohen, Yossef Peri-Paz, Nadav Shefer. 
 This Standard was approved by the following me mbers of Technical Committ ee 801– medical electrical 
equipment: 
 
Kibbutz Industries Association –  Moshe Samuel Federation of Israeli Chambers of Commerce  –  Doron Orbach Association of Electronics & Software Industries – Danny Even-Chen, Zvika Gilad Government hospitals – Rozelia Riabuch 
Private hospitals – Ziv Zach 
Israel Institute for Occupational Sa fety and Hygiene – Alex Toretzky 
The Israel Consumer Council – Michael Shizef Israel Electric Corp. – Dror Ken-Dror 
The Standards Institution of Israel –  Irena Antonov 
Ministry of Heath – Alexander Vilensky (chair) The Histadrut Consumer Authority    – Shai Granot  Ziva Shalev coordinated the preparation of the Standard.  Draft of SI 60601 part 2.2 (2008) 
Notification of the Israeli Standard’s degree of  conformity with Revision notification  
foreign standards and documents    
This standard, except for the changes and additio ns indicated therein, This Standard replaces 
is identical to the International Electrotechnical  Commission standard  Israeli Standard SI 1011 
IEC 60601-2-2 Forth edition: 2006-07   part 2.2 of March 2002 
Descriptors : 
Medical equipment, electric medical equipment, electrical safety, safety measures, surgical equipment, high frequencies. 
The Standard’s updated status 
The Israel Standards are reviewed periodically, at least  once every five years, in order to adapt them to 
scientific and technological developments. 
Those using the Standards must ensure that they ha ve the updated version including its amendment sheets. 
A document published in the Reshumot (Official |Ga zette) as an amendment sheet can be a separate 
amendment sheet or integrated into the Standard. 
The Standard’s validity 
An Israeli Standard including its am endments enters into effect fro m the date it is published in the 
Reshumot. 
One should check whether the Standard is official or whet her parts of it are official. An official Standard or 
official amendment sheet (in its entirety or partly) is effective 60 days from publication of a notice in the Reshumot, except if the notice specifies a later effective date.  
Israeli Safety Mark 
Anyone manufacturing a commodity, which complies with the requirements  
of the Israeli Standard that applies to it, is entitled, under permit from  [Symbol] 
the Standards Institute of Israel, to ma rk it with the Israeli Safety Mark:  
Copyright 
© No part of this publication may be photocopied , published or otherwise reproduced without prior 
permission in writing from the Standards Institution of Israel.1 SI 60601 part 2.2 (2008) 
 
Introduction 
This Standard is the International Electrotechnical  Commission Standard IEC 60601-2-2 (Fourth Edition) of 
July 2006, which was approved as the Israe li Standard with changes and additions. 
 The Standard includes the following items, in the order detailed below: - The applicability clause and its objectives, with changes (in Hebrew). 
- Details of the changes added to clauses of  the international standard (in Hebrew) 
- The international standard (as it is written) 
This Standard is part of a series of Standards applicable to Medical electrical equipment safety. 
The parts of the series are as follows
a: 
SI 60601 part 1     Medical electrical equipmen t: General requirements for basic safety and essential 
performance. 
SI 1011 part 1.1 Medical electrical equipment: General safety requirements – Collateral standard: 
Safety requirements for medical electrical systems. 
SI 60601 part 1.2 Medical electrical equipment: General requirements for basic safety and essential 
implementation – Collateral standard: Electromagnetic compatibilityb – 
requirements and tests.  
SI 1011 part 2.1 Medical electrical equipmen t: Particular safety requirements for electronic 
accelerators in the range 1 MeV to 50 MeV. 
SI 60601 part 2.2 Medical electrical equipment: Particular requirements for the safety of high 
frequency surgical equipment. 
SI 1011 part 2.3 Medical electrical equipment: Par ticular safety requirements for short-wave therapy 
equipment. 
SI 1011 part 2.4 Medical electrical equipmen t: Particular safety requirements for cardiac 
defibrillators.  
SI 1011 part 2.5 Medical electrical equipmen t: Particular safety requirements for ultrasonic 
physiotherapy equipment. 
SI 1011 part 2.12 Medical electrical equipment: Pa rticular safety requirements for lung ventilators – 
intensive care lung ventilators. 
                                                 
a The parts of the series numbered SI 101 1 will be renumbered in the revision prepared for the series, so that the entire 
series will be numbered SI 60601 according to th e order of the international IEC 60601 standards. 
b In the previous editions of the Israeli Standards,  which discuss electromagnetic compatibility, the term 
“electromagnetically suitability” was used as the Hebrew term for the English term electromagnetic compatibility. 2  
SI 60601 part 2.2 (2008) 
 
SI 60601 part 2.13 Medical electrical equipment: Particular requirements for the safety and essential 
performance of anaesthetic workstations. 
SI 1011 part 2.19 Medical electrical equipment: Particular safety requirements for baby incubators 
SI 60601 part 2.22  Medical electrical equipment: Particular requirements for basic safety and essential 
performance of surgical, cosmetic, therap eutic and diagnostic laser equipment. 
SI 60601 part 2.22  Medical electrical equipment: Particular requirements for basic safety and essential 
performance of surgical, cosmetic, therap eutic and diagnostic laser equipment. 
SI 1011 part 2.24  Medical electrical equipment: Particular safety requirements for infusion pumps 
and controllers. 
SI 1011 part 2.27  Medical electrical equipment: Particular safety requirements for 
electrocardiographic monitoring equipment. 
SI 60601 part 2.33  Medical electrical equipment: Particular requirements for basic safety of magnetic 
resonance equipment for medical diagnosis. 
SI 1011 part 2.34  Medical electrical equipmen t: Invasive blood pressure monitoring equipment – 
particular safety requirements. 
SI 60601 part 2.44  Medical electrical equipment: Particular requirements for basic safety of X-ray 
computed tomography equipment. 
SI 1011 part 6  Medical electrical equipm ent safety: Microwave treatment equipment. 
 
  3 SI 60601 part 2.2 (2008) 
 
1. Applicability of the Standard (clause 1 of the internationa l standard with changes).  
Remarks: 
The changes to this clause are in a different font . 
This clause of Israeli Standard SI 60601 part 1 (the  general section of the series of 
Israeli Standards)  is applicable, except for the following: 
 
1.1 Applications of the Standard and its objectives 
Addition: 
This particular Standard determines the safety re quirements for high frequency surgical equipment 
and accessories used in the medical profession, as de fined in clause 2.1.110, and named as follows: 
High frequency surgical equipment. 
High frequency surgical equipment with a nomin al output which does not exceed 50 Watts (e.g. 
micro-coagulation equipment), or equipment used in dentistry or ophthalmology, is exempt from 
compliance with some of the requirements of this pa rticular Standard, as indicated within the relevant 
requirements.  
1.2 Objectives 
Replacement: 
The objective of this particular Standard is to dete rmine the particular requirements for the safety of 
high frequency surgical equipment. 
 4 SI 60601 part 2.2 (2008) 
 
Details of the changes and additions to  clauses of the international standard  
1.3 Particular standards 
The following change applies to this clause: 
Some of the international standards mentioned in th e Standard and detailed in this clause are replaced 
by Israeli Standards as detailed below: 
The international 
standard mentioned The replacement Israeli Standard  Remarks 
IEC 60601-1: 1988 
Amendment 1 (1991) Amendment 2 (1995) SI 60601 part 1
a – Medical electrical 
equipment: General requirements for basic safety and essential 
performance. The Israeli Standard, except for 
the changes and additions indicated therein, is identical to 
international standard   
IEC 60601: 2005 
IEC 60601-1-1: 2000 SI 1011 part 1.1 - Medical electrical 
equipment: General safety requirements – Collateral standard: Safety requirements for medical electrical systems The Israeli Standard, except for 
the changes and additions indicated therein, is identical to international standard   IEC 60601-1 – 1992 Amendment 1 – 1995 
IEC 60601-1-2: 2001 
Amendment 1 (2004) SI 60601 PART 1.2b - Medical 
electrical equipment: General 
requirements for basic safety and essential implementation – Collateral standard: Electromagnetic compatibility – requirements and tests The Israeli Standard, except for 
the changes and additions 
indicated therein, is identical to international standard   IEC 60601-1-2: 2007 
Remarks: 
a. This Standard will enter into force on September 1,  2009. Until then, the equipment must be tested 
according to Israeli Standard SI 1011 part 1. 
b. This Standard will enter into force on September 1, 2009. Until then, the equipment may be tested 
according to Israeli Standard SI 1011 part 1.2 of N ovember 2002 and Israeli Sta ndard SI 60601 part 1.2 
of April 2008.