[ARTICLE] IEC 60601 standard series
Medical devices are intended to be used in combination with human beings. Ensuring the safe and effective use of such devices is mandatory according to the European Medical Device Regulation (EU 2017/745) and other legislations regulating medical devices worldwide.
Manufacturers of medical devices are obliged to show compliance to technical state-of-the-art. For instance, the standards of the IEC 60601 series applicable to electrical medical equipment, are listed as consensus standards recognized by the U.S. Food and Drug Administration, and constitute harmonized standards according to Medical Device Directive 93/42/EEC, soon to be also harmonized under MDR. Compliance “can” be demonstrated with the help of the IEC 60601 series of collateral and particular standards for medical electrical equipment. To give more sense to the word “can”, it would be difficult to justify deviation from these standards to a regulatory authority such as a Notified Body, or the FDA.
What are the IEC 60601 standard series?
The IEC 60601 standard series consists of several collateral (horizontal standards like IEC 60601-1-XX which define general requirements for safety and performance) and particular (vertical standards like IEC 60601-2-XX which define product-related requirements) standards and refers to process standards which need to be considered during the different life cycle phases of a medical device. It shall be emphasized that the requirements of applicable particular standards take priority over the general standards, for instance IEC 60601-1.
Medical electrical equipment needs to be evaluated according to IEC 60601-1 general requirements for basic safety and essential performance, IEC 60601-1-2 electromagnetic disturbances – requirements and tests, and IEC 60601-1-6 for usability. Further applicable product standards need to be selected depending on the intended use, intended user and intended use environment of medical electrical equipment.
The IEC 60601-1 standard series is strongly linked to ISO 14971 for application of risk management to medical devices. If the medical electrical equipment uses software, IEC 62304 is applicable as well. IEC 62366-1 for application of usability engineering to medical devices needs to be considered as part of the usability process in combination with IEC 60601-1-6. ISO 14971, IEC 62304 and IEC 62366-1 are so-called process standards to ensure the right process level to guarantee safe and effective medical electrical devices.
Beside the above-listed standards, there is a huge variety on standards for components which will be used within the medical electrical equipment, such as:
And many more…
To meet the general requirements for implementing components in a medical electrical equipment the Conditions of Acceptability (CoA) of such components needs to be considered and verified in the end use of the medical electrical equipment. Considerations for the testing to demonstrate compliance with the IEC series of standards are illustrated through two business cases described below.
Business case 1 – IEC 60601-1 Electrical Safety for a key component of the product
A medical device manufacturer would like to integrate Switch Mode Power Supply (SMPS) in a medical electrical equipment as power supply. Selection of SMPS is important depending on the construction of the Medical Electrical Equipment (MEE). Based on the intended use, intended environment and operational modes of the MEE the following aspects need to be considered for introduction of SMPS:
As a consulting firm, Medidee usually participates at this stage in different ways. On one side, Medidee helps the medical device manufacturer to identify and define the correct specifications, not only in terms of electrical performance, but also in terms of coherence of the options above. Secondly, Medidee assists in making sure that coherence between the different part of the regulatory documentation is maintained along the design and approval process and, also, that possible changes made along the way are handled correctly.
During the certification process with an external ISO/IEC 17025 accredited testing laboratory, relevant tests to verify the applicable requirements will be conducted with the Equipment Under Test (EUT). In this context, Medidee is there to independently support the legal manufacturer of the medical device in the selection and activation of the adequate laboratory.
It is very important to specify requirements in an early development phase to avoid cost intensive design changes during the certification phase of the device. It should be kept in mind that SMPS is part of the insulation diagram and list of critical components of MEE. Furthermore, the electrical and electromagnetic compatibility risk of a MEE needs to be evaluated within the risk management file according to ISO 14971.
Business case 2 – IEC 60601-1-2 EMC testing
A medical device manufacturer would like to initiate certification according to IEC 60601-1-2 to introduce the MEE into the market. First of all, the manufacturer needs to identify which clauses of the standard are applicable for the EUT. Secondly, the medical device manufacturer needs an external ISO/IEC 17025 accredited testing laboratory which has the standard within its scope of testing. According to clause 6.2 Test plan of IEC 60601-1-2, a detailed test plan shall be provided to the test laboratory.
Annex G of IEC 60601-1-2 provides recommendations regarding the minimum test plan contents. However, this information is quite cryptic for non-specialists. This is where Medidee contributes by ensuring the right options and test conditions are selected.
An important aspect for correct EMC testing is the evaluation of operational modes for testing and classification of essential performance. The test requirements can be structured in electromagnetic emission and electromagnetic immunity, as shown below:
Electromagnetic emission – “how does the medical device perturbate the others”:
Electromagnetic immunity: – “how can the medical device be perturbed by the others”
HOW MEDIDEE CAN HELP
Medidee has extensive expertise in the IEC 60601 series and assists manufacturers in identifying the applicable standards and clauses, and in demonstrating compliance with the relevant requirements during different life cycles phases of the medical electrical equipment.
In addition, Medidee supports the communication with external accredited testing laboratories and notified bodies to ensure a smooth certification process of the medical electrical equipment.