Medical electrical equipment standardization


In the age of modern technology, many corporations focus on the development of innovations related to the improvement of production aspects. But nevertheless, human health remains at the forefront of the key issues of modern problems. Since this aspect in the context of the engine of progress is the main one, then all financial markets and their development form new trends. To regulate most of the issues arising in the field of medicine, international standards are created, which are responsible for the creation of a single system of safety and quality. Today we will acquaint you with some of the latest documents that will help your business reach international scale in the most harmonious and productive way.


Medical electrical equipment - Part 2-66: Particular requirements for the basic safety and essential performance of hearing aids and hearing aid systems


IEC 60601-2-66:2020


Medical equipment requires a clear regulatory system to minimize potential risks. Achieving the highest quality result at the international level is possible if such international standards as IEC 60601-2-66: 2020 are observed.


IEC 60601-2-66: 2019 is available as IEC 60601-2-66: 2019 RLV which contains the International Standard and its Redline version, showing all changes in the technical content compared to the previous edition IEC 60601- 2-66: 2019 applies to BASIC SAFETY of HEARING AIDS and HEARING AID SYSTEMS, hereinafter also referred to as ME EQUIPMENT or ME SYSTEM. IEC 60601-2-66: 2019 cancels and replaces the second edition published in 2015. It constitutes a technical revision.


This edition includes the following significant technical changes with respect to the previous edition:


- revision of the definition of ESSENTIAL PERFORMANCE;


- revision of the application of IEC 60601-1-2: 2014 for electromagnetic disturbances;


- voltage correction used for hearing aids from 1.6 V to 4.5 V;


- correction of the drop test level from 1.5 m to 1.0 m;


- correction of the wording of IEC 60601-2-66: 2015.

A clear specification of the technological parameters given in this document makes it possible to understand the possibility of introducing it into the existing operational activities of your organization. If you have any questions about this standard, our team will be happy to help you.

Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source


IEC 60601-2-31:2020

Technological safety issues have recently shifted to the field of medicine. In the light of recent events, this industry has undergone significant transformation processes and, as a result, has led to the emergence of new requirements and standards, one of which is IEC 60601-2-31: 2020.


IEC 60601-2-31:2020 is available as IEC 60601-2-31:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition. IEC 60601-2-31:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of EXTERNAL PACEMAKERS powered by an INTERNAL ELECTRICAL POWER SOURCE, hereafter referred to as ME EQUIPMENT.


This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition:

The requirement for testing for energy reduction has been removed;


The test for exposure to external defibrillation has been completely revised;

The exclusion for testing ESD immunity only with respect to air discharges has been removed;

Alignment with the latest edition of ISO 14708-2 for pacemakers, as well as the associated EMC standard ISO 14117;


If the above technologies are used in your field of activity, then we strongly recommend that you have this document available to be sure not only the high-quality result of using the equipment, but also to gain the opportunity to go global.


Medical electrical equipment - Part 2-20: Particular requirements for the basic safety and essential performance of infant transport incubators


EN IEC 60601-2-20:2020


Electrical equipment has a large number of technological parameters that must be strictly checked by both the manufacturer and the consumer. Sometimes, differences in legislation and requirements of individual countries can be in significant conflict with each other. It is to regulate such situations that such international standards as IEC 60601-2-20: 2020 are created.


IEC 60601-2-20:2020 is available as IEC 60601-2-20:2020 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-20:2020 applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of INFANT TRANSPORT INCUBATOR equipment, as defined in 201.3.208, also referred to as ME EQUIPMENT.


IEC 60601-2-20:2020 specifies safety requirements for INFANT TRANSPORT INCUBATORS, but alternate methods of compliance with a specific clause, by demonstrating equivalent safety, will not be judged as non-compliant, if the MANUFACTURER has demonstrated in his RISK MANAGEMENT FILE that the RISK presented by the HAZARD has been found to be of an acceptable level when weighed against the benefit of treatment from the device.

This edition constitutes a technical revision. IEC 60601-2-20:2020 includes the following significant technical change with respect to the previous edition: re-dating of normative references.


Both the production and operation of medical devices are complex concepts that need to be structured and controlled at every stage. If the presence of this standard may correspond to the nature of your activity, please pay attention to the above recommendations and familiarize yourself with them in more detail by clicking on the link to our website.


Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment


EN IEC 60601-2-22:2020


The diversity of medical equipment implies the creation of separate categories and the structuring of existing systems. But regulation can also be carried out at the global level by such international standards as IEC 60601-2-22: 2020.

IEC 60601-2-22:2019 is available as IEC 60601-2-22:2019 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60601-2-22:2019 applies to the Basic Safety and Essential Performance of laser equipment for surgical, therapeutic, medical diagnostic, cosmetic or veterinary applications, intended for use on humans or animals, classified as Laser Product of Class 1C where the Enclosed Laser is of Class 3B or 4, or Class 3B, or Class 4.


This fourth edition cancels and replaces the third edition published in 2007 and Amendment 1:2012. This edition constitutes a technical revision.


This edition includes the following significant technical changes with respect to the previous edition:

  • it takes account of IEC 60601-1:2005/AMD1:2012 and IEC 60825-1:2014, which have been published since publication of the third edition;

  • it addresses technical and safety issues which have arisen since publication of the third edition;

  • the scope of this fourth edition differs from the scope of the third edition. It now includes Class 1C laser equipment, as defined in IEC 60825-1:2014, when the Enclosed Laser is Class 3B or 4;

  • LED (light emitting diode) products are now excluded from this document as medical LED products may be covered by IEC 60601-2-57.


In case you used a previous version of the above-mentioned standard, we recommend that you familiarize yourself with its latest update in more detail to meet the latest market requirements. Indeed, in the world of increased competition, only the quality of services and goods can become a guide to leading positions.


Safety assurance is possible with the international standards


Development is synonymous with the word progress, and therefore any progress implies the introduction of new technologies. Sometimes it is difficult to control the global and local areas of your business, especially given the pace of development of reality. But then such global organizations as ISO and IEC come to the rescue, which can not only accelerate the pace of scaling of your business, but also structure existing systems. That is why we strongly recommend having the key standards for your business in place to ensure the quality of the final product in both physical and digital reality.


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