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New Japan Oriented International Safety Standard for Advanced Medical Equipment New steps toward promoting exports of treatment equipment worldwide

Medical plasma technology is a next-generation medical technology that permits minimally invasive treatments to reduce the physical burdens on patients, which has been advancing worldwide. Against this backdrop, Japan submitted a proposal to the International Electrotechnical Commission (IEC) for international standardization of safety of medical plasma equipment, a technology expected to be utilized in surgical operations, a field which has a high degree of difficulty in obtaining approval for medical equipment worldwide. In response, the IEC issued new international standards for this technology. This is expected to promote the introduction of Japan-oriented advanced medical technologies into international markets.

1. Background

Plasma technology is a next-generation medical technology expected to be applied to the field of therapeutic instruments, including minimally invasive hemostasis equipment for surgery operations that causes minimal heat damage to patients accompanied with arrest of bleeding during operations. In light of this situation, related industries have requested the establishment of evaluation standards and ensure medical reproducibility of medical plasma equipment. This will allow medical practitioners to effectively make use of such equipment and to permit doctors to take same-level treatments regardless of their skill levels.

To export medical plasma equipment to other countries, and encourage greater utilization of the equipment, the products are required to pass examinations under the technical regulations of destination countries in terms of safety for medical equipment. Japan considers that the development of new international standards in safety, will offer a basis for such countries' technical standards and will contribute to making this procedure smoother.

Figure: Example of low energy ionized gas hemostasis equipment

2. Background to the issuance of the new standards and outline thereof

In light of this situation, in November 2014, Japan submitted a proposal to IEC TC 62/SC 62D (electromedical equipment) for new international standardization for safety of medical plasma equipment (low energy ionized gas hemostasis equipment). Following this, representatives of Japan, members of the National Institute of Advanced Industrial Science and Technology (AIST), universities and other institutes continuously participated in discussions with other member countries and coordinated new standards with experts of Germany, Italy, the United States and several other countries. As a result of these discussions, in April 2018, the IEC issued new standards based on Japan’s proposal.

The outline of the newly issued international standards (IEC 60601-2-76: 2018 Low energy ionized gas hemostasis equipment) are as follows.

  • To secure the safety of low energy ionized gas hemostasis equipment, the new international standards define the hemostasis principles, as a basic function, and stipulate test methods to define minimum-required technical specifications on safety based on the principles, including protection against electrical hazards (current values, frequency characteristics, insulation etc.), excessive temperatures and other hazards.
  • The new international standards newly define terms for the equipment so as to explicitly stipulate the differences in characteristics between the conventional individual standards and the new IEC standards.

3. Expected effects

The new standards will contribute to objective and effective assessment of medical equipment that derived from Japan-oriented innovative technologies. Japan expects that Japanese medical equipment, which is designed and produced complying with these standards, will disseminate to worldwide medical sites, and enhance Japanese related industries’ competitiveness in global markets.

To encourage the smooth export of Japan-oriented advanced medical technologies by Japanese companies, including low energy ionized gas hemostasis equipment, to the rest of the world, METI will strive to assist rule-making activities, including international standards.

Note: This successful standardization is partly due to the achievements under the Strategic Development of International Standards project (international standardization for medical plasma equipment, etc.), which METI has commissioned to an entity.

Release date

May 15, 2018

Division in Charge

International Standardization Division, Industrial Science and Technology Policy and Environment Bureau

Ministry of Economy, Trade and Industry1-3-1 Kasumigaseki, Chiyoda-ku, Tokyo 100-8901, Japan Tel: +81-(0)3-3501-1511
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