The IEC 60601 standard for medical electrical equipment

The IEC 60601 series of standards (in Germany: DIN EN 60601) regulates how fundamental aspects of functional and patient safety, IT safety and ergonomics of medical electrical equipment (ME equipment) are to be ensured and tested. We explain what the standard includes in particular and answer the most important questions about IEC 60601.

 

Content

• What does IEC 60601 contain?
  • What is meant by ME devices?
• The standards of the IEV 60601 series
  • Supplementary standards (Collateral standards)
  • Special specifications (Particular standards)
• Security: IEC TR 60601-4-5
• Consulting and development based on 60601
• Frequently asked questions and further information
• Buy IEC 60601

 

What does IEC 60601 contain?

The international IEC 60601 series of standards contains requirements for safety and ergonomics of medical electrical equipment. It is identical to the European standard EN 60601 (in Germany: DIN EN 60601) and deals with aspects of electrical, mechanical, electromechanical, thermal and functional safety of ME devices.
The base standard IEC 60601-1 specifies general safety and performance requirements for ME equipment; this is intended to eliminate unacceptable risks to patients or operators. In addition, IEC 60601-1 provides definitions and regulates the identification and the labeling of ME equipment.

What is meant by ME equipment?

ME equipment (medical electrical equipment) are devices and systems that

• come into direct physical or electrical contact with patients,
• are connected to an (electrical) supply network,
• are used for the diagnosis, the treatment or the monitoring of patients or for the alleviation or compensation of a disability, disease or injury.

 

The standards of the IEC 60601 series

The first edition of the basic standard IEC 60601-1 was published in 1977. Since then, the technology of ME devices has developed significantly ( e.g. digitalization); as well the application scenarios for the devices have become more complex. Accordingly, IEC 60601 has been further developed and continuously amended over the years.
In addition to the basic standard, there is now an extensive catalog of supplementary standards and so-called "special specifications" as well as a technical report (see below: Security: IEC TR 60601-4-5).

Supplementary standards (Collateral standards)

The supplementary standards or collateral standards (IEC 60601-1-XX / EN 60601-1-XX) specify requirements for specific groups or product classes of medical electrical equipment that go beyond the requirements of the basic standard.

• IEC 60601-1-2 Electromagnetic disturbances - Requirements and test
• IEC 60601-1-3 General radiation protection, diagnostics
• IEC 60601-1-6 Usability
• IEC 60601-1-8 General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
• IEC 60601-1-9 Reduction of environmental impacts
• IEC 60601-1-10 Physiologically closed control loops
• IEC 60601-1-11 Medical technology in domestic environments
• IEC 60601-1-12 Medical technology in the environment of emergency use

The supplementary standards IEC 60601-1-1 (Specifications for the safety of medical electrical systems) and IEC 60601-1-4 (Programmable electrical medical systems) have been withdrawn as such and integrated into edition 3 of the basic standard.

Special specifications (Particular standards)

Special specifications or particular standards (IEC 60601-2-XX / EN 60601-2-XX) contain detailed requirements and tests for specific products or features of medical devices, e.g. IEC 60601-2-12 for respiratory equipment or IEC 60601-2-66 for operating light and examination lights. The requirements of the special specifications supplement, extend or replace the requirements of the basic and supplementary standards.
In principle, the regulations of the special specifications take precedence over the supplementary standards and basic standard. As a rule, however, they contain specific references to the applicable edition of the basic standard and of the supplementary standards.

 

Security: IEC TR 60601-4-5

The Technical Report IEC TR 60601-4-5 (Guidance and evaluation - Security-related technical requirements for security) has been available since the beginning of 2021. Among other things, it provides specific information on which measures must be taken to improve the IT security of networked medical devices and protect them against unauthorized manipulation or access from the Internet or via the IT network. To achieve this, various security levels for different security requirements are defined both for the security to be achieved and for the security level which has actually been based on the risks associated with possible security problems of networked medical devices. In addition to possible economic damage (such as failures, data theft, product damage), safety (functional safety, operator and patient safety) as well plays an important role in the risk assessment.
The Technical Report is a further addition to the basic standard EN 60601-1 and applies to all systems that are integrated into IT networks - i.e. also to electrical euipment that is not connected to an electrical supply network, e.g. battery-powered implantable devices or medical device software.
IEC TR 60601-4-5 comprehensively references the industry standard IEC 62443 and applies its metrics (IT security of industrial automation and control systems), since the cybersecurity requirements of this series of standards are to a large extent transferable to those of networked medical devices. Like this standard, the Technical Report considers the security of the entire system over the system's entire life cycle.

 

Consulting and development based on IEC 60601

NewTec offers manufacturers comprehensive support in the development of ME equipment based on IEC 60601. As specialists in functional safety and with our long-standing experience in usability engineering, we ensure that your medical devices meet all the safety and ergonomics requirements set out in IEC 60601 - not only with ourviable concepts and support in development but also with the creation and provision of our special hardware and software.
Our security specialists also support you in the development of new medical devices by offering security analyses and security engineering, taking into account all normative requirements such as IEC 60601-4-5, IEC 62443 and ISO/IEC 27001 - and advise you on protection against sabotage attacks and external manipulation. Learn more about our IEC 60601 consulting and development services.
As a reliable development partner, NewTec is certified according to DIN EN ISO 13485 as an extension to ISO 9001.
Questions? Contact us: Contact
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Frequently asked questions and further information

What is the DIN EN 60601?

EN 60601 is the European version of the international IEC 60601 series of standards. In Europe it is issued and published by CENELEC (European Committee for Electrical Standardization) as a European standard. In Germany, the standard is published by the German Institute for Standardization (Deutsches Institut für Normung, short DIN) as DIN EN 60601

What is the current version of the IEC 60601?

In 2005, IEC 60601 was completely revised. With this third edition, among other things, risk management (according to ISO 14971) became an important part of the safety of ME equipment. The current version is edition 3.2 - with it, the standard now comprises a total of about 1,500 specific individual requirements.

Is the IEC 60601 mandatory?

As with all standards, the application of IEC 60601 is not required by law. However, its requirements are considered "state of the art" and the compliance with it is a basic prerequisite for the market launch of medical electrical equipment in Europe and, beyond, in many countries and markets worldwide.

The IEC 60601 and the MDR (Medical Device Regulation)

Compliance with IEC 60601 also serves as evidence of conformity with the applicable General Safety and Performance Requirements (GSPRs) of the Medical Device Regulation (MDR) (EU) 2017/745. However, IEC 60601 is currently not harmonized with the MDR.

Where can the IEC 60601 be obtained?

The current German version (DIN EN 60601-1:2022-11) of the IEC 60601-1 can be purchased from Beuth Verlag. The Technical Report IEC TR 60601-1-4-5 can also be purchased there.