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Free Guide to IEC 62353

Free guide to IEC 62353

Welcome to Rigel Medical, we've been pioneers of biomedical testing and measurement equipment for over 37 years

we have produced our FREE Guide to IEC 62353 as a guideline for people involved in testing medical electrical equipment (ME equipment).

The aim of this booklet is to help the reader to:

  • Appreciate the basics of electrical safety.
  • Understand the reasons behind and the purpose of the IEC 62353 publication.
  • Provide an understanding of the benefits of using the different tests available, in order to help them prepare the adoption of the IEC 62353 standard.

Please complete the form on this page to access the download link for our free guide to IEC 62353.

What's in Rigel Medical's free guide to IEC 62353?


This section talks about electrical current, the human body and how it conducts current, and IEC 60601 Body Model.

Medical Electronic Equipment

Commonly used terms and definitions in IEC 62353 / 60601, symbols and markings, and product lifecycle care covered in this section.

IEC 60601

You can find in-depth information on IEC 60601, including in-service test requirements in this part of the free guide.

Introduction to IEC 62353:2014

This section compares IEC 62353 with IEC 60601, and talks about test conditions, test frequency and preparation

Visual Inspection

This section covers the importance and process of visual inspection when testing to IEC 62353.

Earth Bond Testing

Earth bond test considerations and precision vs accuracy are discussed in this section.

Insulation Resistance Test

Featuring digagrams, this section covers Insulation Resistance EUT to Earth, Insulation Resistance Applied Parts, Insulation Resistance Applied Parts, and Insulation Test Pass – Fail Limits to Mains

IEC 62353 Leakage Measurements

You can find a comprehensive overview of Insulation Resistance Test covering:

  • Method Characteristics - Direct Leakage, Differential Method and Alternative Method.
  • Equipment Leakage - Equipment Leakage Direct Method, Equipment Leakage Differential Method, and Equipment Leakage Alternative Method.
  • Applied Part Leakage - Applied Part Leakage Direct Method, Applied Part Leakage Alternative Method.
  • Secondary Earth Problems.
  • Live to Earth Voltage.

Record Keeping

This section covers gathering and comparison of data collected, including what information should be included in the data logged.


here you will find a brief overview of what has been covered in the guide and what the IEC 62353 standard will provide.


This contains reference tables for pass fail limits, standards, and documentation templates.

Our IEC 62353 test solutions

We have a selection of electrical safety analyzers that will help you test to IEC 62353. Take a look at them below and get in touch if you would like more information, a free online demonstration, or a quote.

The Rigel 288+ Electrical Safety Analyzer

Rigel 288+ Electrical Safety Analyzer

The Rigel 288+ electrical safety analyzer offers an accurate and fast solution for meeting international and local safety standards.

Test to IEC/EN 62353, AAMI/IEC/EN 60601-1 & more
Built -in electronic data storage
Flexible user-definable test routines
Battery-powered leakage, insulation & earth/ground bond tests
50/100/250/500V DC insulation testing

Find out more

The Rigel SafeTest 60 Electrical Safety Analyzer

Rigel SafeTest 60 Electrical Safety Analyzer

The Rigel SafeTest 60 is a robust, reliable and dedicated medical safety analyzer. It is ideal for testing high volumes of medical and laboratory equipment that does not require patient lead testing

Compact, robust and portable design
Fast step-through of test routines with minimised power breaks
Manual control of fault conditions
Tests to a range of international standards including IEC 60601, 62353, 61010 and NFPA-99
Secondary earth warnings to ensure valid test setup

Find out more

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