July 16, 2019
*This press release was revised on August 1st, 2019, because the term "safety performance" was corrected to “safety requirement."
Amid increasing demand for minimally invasive surgical operations, many countries have been advancing the development of surgical robots and overcome current technical and other challenges, such as the need for precise manipulations and limited fields of view.
Against this backdrop, the International Electrotechnical Commission (IEC) issued an international standards for safety requirements of surgical robots based on a proposal from Japan. This issuance is expected to contribute to encouraging Japanese advanced medical technologies to enter international markets.
Robotically assisted surgeries make possible fine manipulations or manipulations that human operators cannot achieve.Along with other countries, Japan has been engaging in efforts for the development of technologies that make possible early enucleation of cancers, fine orthopedic surgeries, and other operations across the borders of the precision mechanical engineering, information engineering, and material engineering.
To encourage more people in other countries worldwide to utilize surgical robots, based on laws and regulations of destination countries in terms of safety requirements for such robots. International standards for safety requirements are to be considered prerequisites for examination criteria.
- Traction Inc.
- Japan Agency for Medical Research and Development (AMED) and Keio University, etc.
- Riverfield Inc.
2.Background to the issuance of the new standards and outline thereof
In developing standard for safety requirements of surgical robots, it is important to consider the safety requirements from a mechanical perspective (e.g., industrial robots),as well as from the perspective of stakeholders in the medical practices . Taking these two aspects into consideration, seven countries, including Japan, proposed to have a joint working group of the International Organization for Standardization (ISO) and International Electrotechnical Commission (IEC), bringing together experts in the two aspects, and the working group was established.
In July 2015, the working group started a series of deliberations on new standards for safety requirements of surgical robots. As representatives of Japan, the members of the National Institute of Advanced Industrial Science and Technology (AIST) continued participation in the deliberations and coordinated a new standard with experts from China, Germany, the ROK, the United Kingdom, the United States and other countries. As a result of these deliberations, in July 9, 2019, the IEC issued international standard.
Highlights of the issued international standard (IEC 80601-2-77: 2019 Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential requirements of robotically assisted surgical equipment) are as follows:
- Addition and relaxation of the requirements in light of the characteristics of surgical robots, which are individual safety standards involving IEC 60601-1 (corresponding domestic standards: JIS T0601-1: Medical electrical equipment - Part 1: General requirements for basic safety and essential requirements);
- Standards applicable to surgical robots in a variety of use, not limited to robots for endoscopic surgeries or fine orthopedic surgeries;
- Establishment of requirements for detachable parts of surgical equipment, such as tests for the strength of the detachable parts;
- Adoption of a protective-stop function, which has been introduced in ISO 13482 for safety requirements for personal care robots;
- Presentation of examples involving alternative test methods for strength tests for support mechanisms suitable for robots; and relaxation of requirements for safety rates; and
- Presentation of examples involving methods for testing the resistance against electromagnetic interference from electrical surgical equipment (electrical scalpels).
The IEC adopted the test methods shown in Items (5) and (6) based on Japan’s proposal derived from the test methods undertaken in Japan and the methods recommended in the R&D Guidelines for Medical Devices.
3. Expected effects
The United States and many other countries and regions have shown their intention to introduce the standards into their domestic standards. This introduction is expected to facilitate smooth assessment and approval, in other countries, of Japanese medical equipment derived from innovative technologies. Japan expects that Japanese medical equipment industries will design and produce such equipment in compliance with the standard and disseminate their made-in-Japan medical equipment as safe and secure to medical sites worldwide and that these efforts will contribute to enhancing such industries’ competitiveness in global markets.
To encourage Japanese companies in the field to smoothly provide Japan-oriented advanced medical technologies to the rest of the world, METI will strive to assist rule-making activities, including international standards.
In addition to the standard for safety requirement of surgical robots, on the same date, the IEC also issued international standard IEC 80601-2-78 for safety requirement of RECA(rehabilitation, assessment, compensation or alleviation) medical robots for supporting impaired patients.
Division in Charge
International Standardization Division, Industrial Science and Technology Policy and Environment Bureau