Title:

TC 62: Medical equipment, software, and systems

Scope:

To prepare international standards, and other publications, with focus on safety and performance of medical equipment, software, and systems.

Note:

TC 62 coordinates and addresses emerging technologies not previously covered in its subcommittees. SC 62A works on common aspects of medical equipment, software, and systems. Particular medical equipment, software, and systems are covered in SC 62B, SC 62C, and SC 62D.

Trends and technology background:

Health and healthcare are very broad fields. TC 62 and its subcommittees focus on the relatively small subset where healthcare professionals interact with a person (or animal, often called a "patient") for a medical purpose. Collaboration here called interaction can take place spatially separated and staggered (applications in the home environment, time-delayed reporting, 24x7 measurement data acquisition, etc.). There are also cases, where the same technology is distributed without an interaction with a healthcare professional aka “over the counter”, but the way how the patient gets access to the technology should not influence the safety of medical equipment, software, or system. And in this subfield of health and healthcare, the focus is again primarily on standards for safety and performance.

Note: Different regulators may assess products differently. The committee attempts to cover the different known scenarios within the scope of its work defined above. Ultimately, it is always up to manufacturers and legislators to decide whether the application of its standards is appropriate in specific cases.

TC 62 has developed a large portfolio of standards here over decades, a significant portion of which are also recognized by regulators around the world. Whereas in the past the focus was exclusively on hardware, software is increasingly being seen not only as a supporting component, but also as the value-adding part of the product. This is also reflected in the new scopes formulated in 2022.

Increasingly powerful computational infrastructure is opening up more and more opportunities to use software. Calculations that were previously not possible at all, or only in large local data centres, can now be executed decentrally within a relatively short time via distributed architectures, which can be spread out across the globe.

This distributed and more powerful infrastructure opens the door to applications of artificial intelligence in all its forms (see also Section F).

This computational infrastructure has also reached the most remote places in the world as well as our private spaces, with generally high acceptance among the population.

For medicine, this means that the medical professional can be supported by devices and software that generate data in the patient's private sphere or perform supportive tasks in a country far away from the professional and the patient. Services from distant specialists are in principle also available in remote locations around the world via internet and cloud capabilities.

On the other hand, the need for protection of the individual and the possibilities to protect them have also increased in general. What was acceptable in the 1960’s when the committee was formed, would not be so accepted today. The well-established standards shall therefore be adapted to the new times and technologies.

It is not possible to predict with confidence, what the future will bring in this field, but we already know several new challenges and hazards related to the safety of the people involved. These need to be addressed by technical and procedural means, since all these kinds of medical equipment are already on the market as regulated devices.

To provide reliable guidance for all involved stakeholders should be a goal for all related committees. Some of these topics will lead to an overlap with the scopes of several other committees (e.g., ISO/IEC JTC 1/SC 41, ISO/IEC JTC 1/SC 42, ISO/TC 150/SC 6, ISO/TC 210, ISO/TC 212, ISO/TC 215, ISO/TC 256). As far as TC 62 is concerned this should be solved by cooperation, as it was in the last decades.

Sub Committees:

SC 62A Common aspects of medical equipment, software, and systems

SC 62B Medical imaging equipment, software and systems

SC 62C Equipment for radiotherapy, nuclear medicine and radiation dosimetry

SC 62D Particular medical equipment, software, and systems

Please see the related websites regarding scope, structure, work programme and liaisons. The data on the website are kept up to date independently of this document.

Healthcare services and the application of medical electrical equipment, medical software, artificial intelligence, autonomy, and IT networks are growing rapidly, driven an aging population.

Information technology is a base technology like electrical power at the beginning of the 20th century. It is not yet clear, what it will be impacted by it in the future and if the society is willing to use the new applications in medical care.

The markets for medical devices and related services are also global. The number of regional regulations affecting medical devices is increasing. New regulations for emerging technologies (AI, computer modelling, etc.) are already in draft form or are expected to be in the foreseeable future. Many regulators use the reference to “recognized standards”*. Around a third of the standards published in the TC 62 remit are recognized by regulators as relevant for market entry.

The standards of TC 62 and its SCs can be most helpful if acknowledged by the regulators since they help them to ease access to the global markets.

It is therefore of importance to consider global regulations, global harmonization of regulations for medical devices (e.g., IMDRF, IAEA, GHWP) and welcome the participation of regulators in the development of standards via delegation of individual experts.

*The concrete term for “recognized” in the sense of “acknowledged by the regulatory body as relevant base to claim compliance to the medical device regulation” differs between regulators.

The standards for medical equipment are used by manufacturers, legislative bodies, healthcare providers, test houses, notified bodies and last but not least by regulatory bodies.

Electrically powered applications used in healthcare include a still growing number of hardware, software and data based technological solutions for diagnostic, therapeutic and health monitoring purposes.

The following non-exclusive list gives some examples for those trends and emerging technologies and shows how general medical trends can be broken down to topics in the scope of TC 62:

• artificial intelligence complements human intelligence in medicine
  • pattern recognition in medical data (e.g., image analysis, waveform analysis)
  • monitoring of medical condition
  • algorithm controlled alarming and alerting for cases of detecting deviations in the medical condition of the patient
  • predictive maintenance of medical equipment
• medical information will be used for secondary medical uses
  • digital twin
  • in silico studies in the medical equipment development
  • brain computer interface
  • image based treatment planning
• robotics
  • robotic services in medicine
  • image guided radiotherapy
• valuable data is collected and evaluated 24x7 as a part of daily life
  • wearable and smart devices of the medical status/condition,
  • connecting these devices via cloud aka “Internet of things” (IoT)
  • patient as medical device operator and connection provider
• executing the functionality at the patient location is no longer mandatory for diagnose and treatment
  • aspects of software and data in (e.g., edge, fog and cloud) applications for medical equipment
  • medical systems alarming and alerting for a specific medical use, e.g., 'silent ICUs',
  • connected medical devices in different levels of IT networks including “home as healthcare hub”
  • remote control of medical equipment and medical software
• increased protection
  • MRI for patients with implants
  • physical security for radioactive material used in medical equipment
  • new methods for lower exposure to radiation or less invasive methods (e.g., flash CT)
  • renewal of medical equipment

Presently, there is no need for a systems approach as outlined in AC/33/2013.

The publications of TC 62 are in line with clause 33 of Part 2 of the ISO/IEC Directives. Most of the standards of TC 62 include test specifications, reproducible test requirements, and test methods.