IEC publishes amendments to key medical device standards

The global medical devices market is booming and expected to reach USD 612.7 billion by 2025, according to a report published by Fortune Business Insights.

The rising prevalence of chronic diseases, growth in surgical procedures, government investment in new generation medical devices and technological advancements are some of the reasons cited for growth.

Manufacturers of medical equipment must follow an increasing number of regulations and laws to ensure the safety of equipment operators and patients. Standards enable manufacturers to consider safety, performance, environmental and other aspects for the equipment’s entire lifecycle.

IEC Technical Committee 62 develops international standards for the basic safety and essential performance of electrical equipment in medical practice. It has recently published the IEC 60601-1:2020 series of standards for medical electrical equipment including the second amendment to IEC 60601-1:2005 and amendments to the collateral standards in the series.

IEC series of standards for medical electrical equipment

The IEC 60601 series of International Standards is comprised of the general standard IEC 60601-1, Medical electrical equipment - Part 1, General requirements for basic safety and essential performance.

In addition to Part 1, the series includes collateral standards, which define further requirements for aspects of basic safety and essential performance, for example, electromagnetic disturbances, usability, alarms, environment and home healthcare equipment. IEC 60601-2-x and 80601-2-x consist of approximately 80 particular standards, which define the requirements for specific products or specific measurements built into products. Some examples include, cardiac defibrillators, magnetic resonance scanners and ventilators for the emergency medical services environment.

e-tech spoke with Charles Sidebottom to find out more about the changes in the amendments. Sidebottom recently served as Assistant Secretary of TC 62 A, which covers common aspects of electrical equipment used in medical practice, and as project leader for the amendments project. With a background in electrical engineering, Sidebottom has been involved in the work of TC 62 for more than 30 years and is currently Managing Partner of PPO Standards.

What are some of the key changes?

Operator and patient protection

Medical electrical equipment is connected to, or used in close proximity to patients, for instance cardiac monitors, syringe pumps and respirators. IEC 60601-1 establishes different requirements, which must be incorporated into the medical devices, for the protection of operators and patients from many types of hazards including electrocution. Examples of requirements for basic electrical safety include a certain creepage distance (shortest path between two conductive parts), safety insulation, an air gap or combinations of these.

Manufacturers of medical electrical equipment must determine the likelihood of a patient being exposed to various hazards and hazardous situations through a formal risk assessment process, using ISO 14971, Medical devices — Application of risk management to medical devices. The IEC 60601 series identifies many of those hazards and hazardous situations and provides generally accepted methods for controlling the risk to the operator and patient.

One of the most important changes in the amendment is the introduction of IEC 62368-1, Audio/video, information and communication technology equipment – Part 1: Safety requirements, which combines safety aspects of IT and audio and video in a single standard.

IEC 62368-1 can be used, where appropriate, as an alternative to IEC 60950-1 when addressing means of operator protection.

In Edition 3 of IEC 60601, we worked to harmonize requirements for operators’ protection with those in IEC 60950-1. This had real benefits, because it allowed manufacturers of medical electrical equipment to use components and power supplies that were mass produced for IT equipment, as long as they provided the appropriate level of isolation and protection for the operator. With the introduction of IEC 62368-1, we’ve developed additions to the standard so people can safely use IEC 62368-1 certified components, power supplies and the like to provide operator protection in IEC 60601.

Electromagnetic disturbances

The collateral standard IEC 60601-1-2 deals with basic safety and essential performance of medical electrical equipment in the presence of electromagnetic disturbances and to electromagnetic disturbances emitted by medical electrical equipment. Amendment 1 has added a new requirement to evaluate the immunity of medical electrical equipment to proximity magnetic fields in the frequency range 9 kHz to 13,56 MHz. This requirement was added due to concerns about the risks associated with fields radiated by a wide variety of sources in both the professional healthcare facility environment and the home healthcare environment that could come into close proximity with sensitive medical electrical equipment. The informative annex, providing guidance on the application of risk management with regard to electromagnetic disturbances, was extensively revised.

Alarms

Another key change is in the amendment for the collateral standard for alarms (IEC 60601-1-8), which covers general requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems. A number of new defined terms added to the collateral and several sections of the document were revised to address inconsistencies identified in the second edition with its Amendment 1.

The existing Annex F on reserved melodies for alarm signals has been deleted and a new Annex G on auditory alarm signals, which consists of an auditory pointer denoting the priority and an auditory icon that creates a strong semantic link to the category it represents, was added. The auditory alarm signals remain optional. However, the intent is to make the auditory alarm signals of Annex G mandatory in the next edition of this collateral standard.

The requirements in IEC 60601-1 related to indicator lights and their meanings have been updated to align with the collateral standard IEC 60601-1-8. The description of the alarm light colour and frequency (flashing or not) are described in more detail. Light indicators are divided into information signals and alarm signals of high, medium and low priority with the type of operator response that is required.

What are the next steps for the IEC 60601 Standard?

Medical device manufacturers will need to look carefully at the amendments and see what the impact is on their specific devices. Writers of the particular standards will take the next two to three years to look at the amendments to see if they need to make revisions that align with the 2020 version of the IEC 60601 general and eight collateral standards.

The time required for the uptake of IEC 60601 Amendment 2 will be a key factor on when serious work will begin on the fourth edition of the standard.

IEC TC 62 has developed an architectural concept for the system of safety standards for medical electrical equipment, medical electrical systems and software used in healthcare. The next step is to develop the design specifications for IEC 60601 Edition 4, which would consider the remaining issues that were not shortlisted for the second amendment, along with state-of-the-art technologies and other things that may come along in the meantime. We have a roadmap, however no firm date has been set for when work will begin.