Free Guide to IEC 62353

Understand the reasons behind and the purpose of the IEC 62353 publication with this free guide

Free guide to IEC 62353

An introduction to electrical safety testing in accordance with IEC 62353


This booklet is written 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.
The healthcare market is technology driven and with a global demand for increased patient safety, there has never been a more prudent time to demand more from your test equipment.

International standards for the development and manufacturing of medical devices put greater emphasis on risk assessment and analyses of data. So, there is an increased need for test equipment that allows the user to automate data capture and ensure validity of test results for better management of risk.



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

Introduction

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.

Conclusion

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

Appendix

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



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