Understanding Requirements Within the IEC 60601-1 Series of Standards

In response to rapid technological advancements in the medical device field, regulatory bodies like the U.S. Food and Drug Administration (FDA) and Health Canada are actively working to ensure that applicable standards are in place that thoroughly account for these innovations.

The first edition of IEC 60601-1, titled “Medical electrical equipment – Part 1: General requirements for safety,” was published in 1977. This standard laid down the basic fundamentals for the safety of medical electrical equipment (ME equipment) and established a framework for subsequent editions and amendments.

Since its initial publication, IEC 60601-1 has undergone several updates to reflect advances in technology, changes in regulatory requirements, and improvements in safety assessments for medical devices. The current edition of IEC 60601-1 is Edition 3.2 and is internationally recognized and accepted by regulatory authorities worldwide.

Keeping Up with Innovation

The landscape of the medical technology (MedTech) industry has undergone significant transformation in recent years, driven largely by advances in technology and a shift towards innovation and entrepreneurship.

Several key trends are contributing to this evolution:

• Integration of advanced technologies: Medical device manufacturers are increasingly incorporating cutting-edge technologies such as artificial intelligence (AI), machine learning, home healthcare, robotics, and wearable technologies into their products. These technologies enhance the capabilities and functionalities of medical devices, leading to more accurate diagnoses, personalized treatments, and improved efficiency in patient diagnostics and treatments.
• Rise of startup companies: The once high barriers to entry in the MedTech industry have been significantly reduced in recent years, fostering the formation of an increasing number of startup companies focused on developing innovative medical devices. These startups often have strong cross-functional teams involved in the development processes, allowing them to bring products to market more quickly and more efficiently than larger, established companies. In addition, innovation hubs, incubators, and accelerators are further supporting the formation and growth of startup companies by providing funding, resources, and mentorship.
• Focus on user-centered design: Previous usability studies show a growing emphasis on designing and developing medical devices that improve the user experience for both healthcare providers and patients. This involves understanding the needs and preferences of these users and designing devices that align with these factors and are easy to use.

Overall, the MedTech industry is experiencing a period of rapid innovation and disruption, driven by technological advances, entrepreneurial spirit, and a growing focus on improving healthcare outcomes. This trend is expected to continue as new technologies emerge and the demand for innovative medical devices grows.

However, while innovation is flourishing in the MedTech industry, startups and small companies face regulatory challenges in bringing their products to market. Navigating complex regulatory pathways and obtaining approvals from certification and regulatory bodies such as UL, CSA, the FDA, and Health Canada to affirm compliance with the applicable safety standards are significant hurdles for MedTech startups.

Fortunately, emerging regulatory frameworks and initiatives aimed at streamlining the regulatory process for innovative medical devices are helping to address some of these challenges.

Common Standards

The following standards are crucial for ensuring the safety and effectiveness of medical electrical equipment (ME equipment):

• IEC 60601-1: Medical electrical equipment –
  Part 1: General requirements for basic safety and essential performance
  
  Key aspects covered in IEC 60601-1 include:

• • Basic safety principles: This standard outlines the fundamental framework for ensuring that the construction and design of the ME equipment conforms with the constructional requirements of the standard. Conformity is further validated by conducting basic safety testing such as electrical isolation measurements, protective earthing, leakage currents, and temperature measurements to ensure the safe operation of ME equipment.
  • Essential performance requirements: IEC 60601‑1, in conjunction with the manufacturer’s requirements, specifies essential performance criteria that ME equipment must meet to ensure its intended function and effectiveness in diagnosing, treating, or monitoring patients’ health conditions.
• ISO 14971: Application of risk management to medical devices [3]
  This standard emphasizes the importance of risk management throughout the lifecycle of ME equipment, from design and development to manufacturing, installation, and use. It requires manufacturers to identify, assess, and mitigate potential risks associated with their devices.

These standards provide comprehensive guidelines for manufacturers to apply during the design, development, and testing phases of product development. In addition, the IEC 60601-1 series of standards are further categorized by the specific type of ME equipment and its intended use. These specific standards provide detailed requirements and guidance tailored to different categories of ME equipment.

The standards are further broken down into the following types:

• Particular Standards: Numbered 60601-2-X/80601-2-X, these standards define the requirements for specific types of ME equipment or specific measurements built into products. Particular standards may modify, replace, or delete requirements contained in the general standard and collateral standards as appropriate for the particular ME equipment under consideration, and may add other basic safety and essential performance requirements [1].
• Collateral Standards: Numbered 60601-1-X, these standards supplement and define the requirements for certain aspects of safety and performance, e.g., electromagnetic disturbances (IEC 60601-1-2), home healthcare (IEC 60601‑1-11), and alarm systems (IEC 60601‑1‑8). Collateral standards complement the requirements contained in the general standard [1]

As of April 2024, there are approximately 78 particular standards and seven collateral standards in the IEC 60601-1 series of standards applicable to various types of ME equipment. Table 1 provides a sampling of some of these standards.

Table 1: Example of 60601-1 series of Collateral and Particular Standards [2]

Standards Addressing Emerging Issues

Home Healthcare

As devices have become smaller in size and with the improved internet/network infrastructure, hospitals and the medical industry are expanding the use of certain ME equipment in environments outside of healthcare facilities, including the home healthcare environment. This effort is being driven by the following factors:

• Patient convenience: Home healthcare allows patients to receive medical care in the comfort of their own homes, eliminating the need for frequent visits to hospitals or clinics. This is particularly beneficial for patients with disability or mobility issues.
• Cost-effectiveness: Home healthcare can be more cost-effective than traditional hospital-based care since it reduces the need for outpatient visits and stays.
• Technological advancements: The miniaturization of medical devices has made it possible to develop smaller, portable devices that can be used at home without compromising functionality or accuracy. For example, devices like portable ultrasound machines, wearable monitors, and home dialysis machines are becoming increasingly common.
• Remote monitoring and telemedicine: With the improved internet and network infrastructure in residential properties over the past decade, remote monitoring of patients’ vital signs and health status is feasible. Healthcare providers have the ability to monitor patients’ conditions in real time and, when necessary, intervene, even from a distance.

Telemedicine platforms also enable virtual consultations between patients and healthcare providers, further facilitating home-based care.

The expanded use of ME equipment in the home healthcare environment led to the publication of IEC 60601-1-11, “General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.” This collateral standard took the IEC 60601-1 General standard one step further in taking into consideration a number of key issues, as detailed in the sections that follow.

Medical Equipment Used by a Lay Operator

Unlike medical devices used in professional environments such as hospitals and clinics, ME equipment used in the home is intended to be operated by non-professionals and even patients. These and other types of lay operators are users with limited knowledge and training in operating the device.

To address these concerns, IEC 60601-1-11 references an additional collateral standard, IEC 60601-1-6, “General requirements for basic safety and essential performance – Collateral standard: Usability.” This usability standard ensures that the ME equipment for home use is simple to use and feature-intuitive, with user-friendly interfaces to accommodate individuals with limited medical knowledge or training. This involves providing non-complex accompanying documents, clear instructions, visual aids, and minimalistic designs to facilitate ease of use.

Device Classification

IEC 60601-1-11 mandates that ME equipment in the home healthcare environment be categorized as a Class II (non-grounded) device, meaning equipment or a device that is only internally powered. The electrical ground found in home healthcare environments is frequently considered to be unreliable when compared to hospitals and other professional healthcare environments. For this reason, pluggable Class I devices (grounded ME equipment) are not permitted.

Class II devices are also known as double-insulated devices. They are designed to provide an extra layer of electrical protection by incorporating two levels of isolation (commonly referred to as double or reinforced insulation) between mains to operator/patient accessible circuits. This design approach is essential in environments where grounding may be unreliable.

Internally Powered Devices

Battery-operated ME equipment and devices offer an additional level of safety by eliminating the need for direct connection to mains supply receptacle. This reduces the risk of shock hazards caused by voltage fluctuations, faulty wiring, or other issues commonly encountered in residential settings. Moreover, battery-operated devices enhance portability and flexibility, allowing users to use the devices in various locations without being tethered to a wall receptacle.

Patient Connections

One crucial aspect of the IEC 60601-1-11 standard is the classification of applied parts, which are parts of the ME equipment that come (or can come) into direct contact with the patient. These applied parts are categorized based on their levels of isolation, patient leakage currents, and their level of protection against the risk of electrical shock under normal and fault conditions.

In the context of the IEC 60601-1 standard, there are three types of applied parts:

• Type B applied parts: These are applied parts that offer the lowest level of protection against electrical shock and patient leakage current. They are typically found in medical devices intended for use in professional healthcare settings, where electrical grounding is reliable and stringent safety measures can be enforced. However, in the home healthcare environment, where electrical grounding may be less reliable, the use of Type B applied parts is restricted due to the higher risk they pose under fault conditions.
• Type BF and CF applied parts: These applied parts provide a higher level of isolation compared to Type B applied parts. Type BF (body floating) applied parts are designed for use in direct contact with the patient’s body, offering a higher degree of protection against patient leakage current. Type CF (cardiac floating) applied parts provide an even greater level of isolation, specifically for devices used in close proximity to the heart or other critical areas.

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By restricting the use of Type B applied parts and requiring the use of Type BF or CF applied parts in home healthcare devices, IEC 60601-1-11 mitigates the risk of electrical shock and patient harm in home healthcare environments where the electrical source may be less predictable.

Environmental Conditions

• Operating temperature range: The operating environment within the home is not as controlled as what is typically found in a professional environment such as a hospital. Therefore, IEC 60601-1-11 stipulates that ME equipment intended for use in the home healthcare environment shall be operable within an expanded temperature range of +5 to +40 degrees Celsius.
• Water ingress protection: Coinciding with the previously discussed requirements for the home environment, IEC 60601-1-11 also requires that ME equipment used in the home healthcare environment conform with the requirements of an IPX1 or IPX2 (transit-operable, hand-held, and body-worn) rating:
  • IPX1 rating: An IPX1 rating for a device is classified as the lowest level of protection against liquid penetration. This test involves dripping water vertically onto the ME surface. The ME equipment is placed onto a turntable rotating at one round per minute and under a drip box proving a flow of water of one millimeter per minute for a duration of 10 minutes. Upon completion of the test, the testing lab identifies any water penetration within the device that could cause a failure of basic safety and/or essential performance requirements.
  • IPX2 rating: Similar to IPX1, the IPX2 test involves dripping water vertically onto the ME surface. The ME equipment is placed onto a turntable rotating at one round per minute and under a drip box providing a flow of water of three millimeters per minute. The test duration is also 10 minutes, but the unit is tested in four 2.5-minute test sections each with a 15-degree tilt. Similar to the IPX1 test, the ME equipment is then evaluated for any water penetration that could compromise basic safety and/or essential performance.
• Mechanical shock/vibration: Unlike a professional healthcare facility, the home healthcare environment is not as controlled and additional rough handling test criteria shall be taken into consideration. For this reason, IEC 60601-1-11 includes selected vibration and shock tests to evaluate how ME equipment responds to these conditions during normal use.
  The test criteria for the shock and vibration tests are selected based on the environment and classification of device (i.e., hand-held, portable, mobile, body-worn, and transit-operable.
  Table 2 outlines the severity level of the mechanical tests based on the ME equipment classification.

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Artificial Intelligence

Autonomous artificial intelligence (AI) is a branch of AI in which systems and tools are advanced enough to act with limited human oversight and involvement. The actions an autonomous AI system can perform range from automating basic repetitive tasks and data analysis to decision making.

Medical device manufacturers are taking this technology into account by implementing advanced sensors, cameras with vision, and software algorithms with AI. Since this technology is still in its early stages, IEC TC62 has been working on the development of a first edition of a new standard, IEC 63450 [2], which will address the technical verification and validation processes applicable to AI-enabled medical devices. IEC 63450 is currently scheduled for publication in mid-2025. [2]

As AI-enabled ME equipment relies heavily on software, medical device manufacturers should also consider applying the requirements of IEC 62304, which defines the life cycle requirements for software within ME equipment. The processes, activities, and tasks described in this standard establish a common framework for medical device software life cycle processes.

The IEC 62304 standard defines three safety classes for medical device software as follows:

• Class A: No injury or damage to health is possible
• Class B: Injury is possible, but not serious
• Class C: Death or serious injury is possible

If ME equipment contains software, regulatory bodies such as the FDA and Health Canada will look for evidence of compliance with the requirements of IEC 62304.

Cybersecurity

With manufacturers now including network capability in ME equipment (technologies such as LTE/5G, WiFi, Bluetooth, or physical LAN connection), there comes a need to ensure that devices are protected against cybersecurity threats. Cybersecurity incidents can render ME equipment and the networks within the hospital environment inoperable, resulting in the delay and disruption of patient care.

Under Section 524B(a) of the FD&C Act, which came into effect in March 2023 [6], the FDA can refuse to consider premarket submissions submitted on or after October 1, 2023, if the premarket submission does not provide documentation that supports claims of compliance with the requirements of Section 524B. The requirements include:

• Having a plan to monitor, identify, and address, as appropriate and in a reasonable time, post‑market cybersecurity vulnerabilities and exploits, including coordinated vulnerability disclosure and related procedures,
• Designing, developing, and maintaining processes and procedures to provide a reasonable assurance that the device and related systems are cyber secure, and make available post-market updates and patches to the device and related systems, and
• Providing a software bill of materials (SBOM) detailing commercial, open-source, and off-the-shelf software components.

Manufacturers should plan ahead and take these requirements into consideration well in advance of their regulatory submissions.

The Future of IEC 60601-1

During the IEC TC62/SC62A meetings in Seoul, South Korea, in September 2023, there was a general consensus between the National Committees (NCs) to move forward with efforts to develop a 4^th edition of IEC 60601-1.[7] The IEC has approximately 12 active working groups involved in the development of the 4^th edition of the standards, each of which is involved in separate aspects of the standard’s revision. No firm date has been set for the publication of the 4^th edition of IEC 60601-1, but most experts expect that a draft of the revised standard will be available for review and comment by mid-2025.

References

• IEC 60601-1 Edition 3.2, “Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.”
• Standards operated by the IECEE
  
• ISO 14971:2019, “Medical devices – Application of risk management to medical devices.”
• Recognized Consensus Standards: Medical Devices.
  
• IEC 60601-1-11:2015/AMD1:2020, “General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment.
• Cybersecurity in Medical Devices Frequently Asked Questions (FAQs).
  
• IEC 60601-1, 4th Edition Project – Where Do We Stand?