METI
Font Size Change
S
M
L
Easy Web Browsing tool

New International Standards for Safety of Advanced Medical Equipment (Photodynamic Therapy Equipment) Issued Issuance of new international standards, a step toward new of therapy equipment to the world

Photodynamic therapy (hereinafter referred to as a “PDT”) is an operative method for treating cancer in which a combination of medical agents that selectively accumulate on target cells to be treated and laser radiation is applied to the target cells. This method has been becoming popular as an option for cancer treatment due to its less invasive nature compared to other surgical therapies and thus reduced physical burden on patients. With this trend in mind, Japan has been discussing the safety of PDT equipment, aiming to develop new international standards in this field, an area where international standards organizations are less likely to approve new standards for medical equipment through their examinations. In part as a result of these discussions, Japan submitted a proposal for the formulation of new standards in this field to the International Electrotechnical Commission (IEC). In response, the IEC ultimately issued new standards for PDT equipment based on Japan’s proposal. Japan expects that new international standards for PDT equipment will bring advanced medical technologies to patients all over the world.

1. Background

Equipment used for PDT, a promising medical treatment categorized in the field of advanced laser therapy, is medical equipment that Japan succeeded in commercializing ahead of the rest of the world. Utilization of this equipment is expected to become popular worldwide in treating various forms cancer, including lung cancer, esophageal cancer, and malignant brain tumors. In order to export PDT equipment to other countries and to encourage its further utilization, businesses are required to pass domestic examinations under compulsory regulations of destination countries in terms of safety and other related issues pertaining to medical equipment. To make this procedure smoother, Japan decided to submit a proposal for stipulating new international standards for this field focusing on individual safety, since these standards are to be considered prerequisites for examination guidelines. In response, the IEC issued new international standards.


Figure 1: Picture of PDT
Medical agent
Cancer
Accumulation
Laser light

Figure 2: PDT equipment
(Source: Meiji Seika Pharma Co., Ltd.)
 

2. Outline of new IEC standards and background to the issuance

Key points of the new standards (IEC 60601-2-75) are as follows:

  • To secure the safety of PDT equipment, the new international standards are to stipulate technical specifications as minimum requirements in order to protect patients from a variety of risks, including electrical and mechanical hazards and excessive radiation and temperatures.
  • The new international standards explicitly stipulate optical properties involving the performance and safety of PDT equipment as well as the relationship between medical agents and PDT equipment, for e.g., light sources and light-guiding paths.

 In January 2015, Japan submitted a proposal for these new international standards for PDT equipment to the TC62/SC62D (electromedical equipment) under the IEC. In response, the IEC held repeated discussions with experts from member countries for stipulating new standards. As representatives of Japan, members of the Institute of Advanced Biomedical Engineering and Science, Tokyo Women’s Medical University, participated in the discussions with other member countries on a continuous basis over approximately two and a half years in order to coordinate new standards. Upon the final member country vote, the IEC approved  and issued new international standards for PDT equipment.

Note: This standardization of PDT equipment is partly due to the achievements under the Strategic Development of International Standards project (international standardization for photodynamic therapy equipment), which has been commissioned by the Ministry of Economy, Trade and Industry (METI).

Release date

August 15, 2017

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
Copyright Ministry of Economy, Trade and Industry. All Rights Reserved.