How to implement the IEC 60601-1 standard when placing medical electrical equipment on the market

Scope

IEC 60601-1 is the umbrella safety standard for medical electrical (ME) equipment. As its name suggests, ME equipment refers to electrical equipment with a medical purpose. It has an applied part (in direct contact with the patient) or transfers energy to or detects energy from the patient while being connected to a particular power supply (mains or internal supply such as a battery); it meets the definition of a medical device as mentioned in Article 2 of Regulation (EU) 2017/745 on medical devices (MDR).

Some examples of medical electrical equipment include electric wheelchairs, massage machines, surgical robots with or without radiotherapy, foot impression devices, operating tables, and cardiac defibrillators. Pacemakers and computers displaying DICOM files are two examples that are not ME equipment – the former because they are active implantable devices covered by the ISO 14708-1 standard and the latter because the stated use does not meet the definition of a medical device; however, as they are nonetheless electrical equipment, they are subject to other European regulations.

Introduction to the requirements in the standard

 IEC 60601-1 sets out general requirements for basic safety and essential performance. As indicated in the title of the standard, three points should be considered:

• The standard is general. This implies that there are other standards in the 60601 series that may apply to the product. These include collateral and particular standards. The collateral standards are additional and are denoted as 60601-1-XX. The particular standards modify, replace or supplement the general standard. They are specific to a type of product, take priority over the general standard and are denoted as 60601-2-XX or 80601-2-XX.
• Basic safety is defined as freedom from unacceptable risk directly caused by physical hazards when ME equipment or an ME system (several ME devices) is put into service. The standard distinguishes between normal conditions (when all means of protection are intact) and single fault conditions (when an anomaly is found or a means of protection is defective). Chapter 13 lists hazardous situations and single fault conditions.
• Essential performance should not be confused with general safety and performance requirements (GSPRs) as described in Annex I of the MDR. The essential performance of ME equipment is determined based on the clinical function of the product. When degradation or absence of the product’s clinical function results in an unacceptable risk, then the product has essential performance.

How should you approach the standard?

 Before you start reading the standard, you should ensure that your product meets the definition of medical electrical equipment given in Article 3.63. If it does, you can start looking for collateral and particular standards that apply to your product. Next, checking the chapters of the standard or of any standards that apply or may potentially apply to your product can provide you with an overview of the tests to be conducted.

IEC 60601-1 describes the tests to be performed to ensure compliance with its own requirements. This will be specifically monitored by the accredited testing laboratory that was contacted with the aim of verifying the product’s compliance with the IEC 60601-1 standard. The laboratory will provide a test report certifying its compliance. 

The test report is not the only compliance document needed to meet the requirements of IEC 60601-1. In fact, to comply with the standard, it is necessary to prepare a risk management dossier compliant with ISO 14971, a usability dossier compliant with ISO 62366-1, a software design and development dossier as appropriate compliant with IEC 62304, and a label and user manual compliant with the requirements on the information to be supplied (ISO 15223-1 and 20417).

In conclusion

ME equipment has to be safe and secure in normal and single fault conditions.

Compliance with the IEC 60601-1 standard (among others) provides presumption of the ME equipment’s compliance with the GSPRs applying to the product. That is why it is necessary to examine and above all to understand this standard in order to find out how to implement it and how to best prevent testing non-compliances.

Why should you turn to Efor for assistance?

Our regulatory affairs experts will be pleased to offer you high-quality support with regard to all of the following topics (non-exhaustive list):

• Regulatory and standards monitoring to identify the regulations and standards applicable to your medical electrical product
• Regulatory compliance of your medical electrical device
• Role of intermediary between you and the laboratory
• Assistance preparing the documentation required to comply with the requirements of IEC 60601-1, ISO 14971, and other applicable standards
• Drafting of technical documentation for your medical electrical device
• Two-day training course: Electrical safety and electromagnetic compatibility of medical devices according to the IEC 60601-1 standard

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