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Research paper : International standardization of four dimensional radiotherapy system (Y. HIRATA et al.)−237−Synthesiology - English edition Vol.7 No.4 (2015) from 2004. Project-Specific Lecturer, Kyoto University Hospital from 2011 to present. In the R&D for motion-tracking radiotherapy and the international standardization activities for 4DRT, made essential contributions to creation of the standard proposal for X-IGRT (IEC 60601-2-68), creation of the revised Japanese standard proposal for external x-ray beam device (IEC 60601-2-1), creation of the 62C/580/NP standard proposal pertaining to motion-tracking radiotherapy, proposal of the standardization strategy, and negotiation with the overseas members.Tsuyoshi SASAGAWAGraduated from the Department of Mathematics, Faculty of Science and Engineering, Waseda University in 1990. Joined the Shimadzu Corp in 1990. In the international standardization activities for 4D radiotherapy, made essential contributions to creation of the standard proposal for X-IGRT (IEC 60601-2-68), creation of the revised Japanese standard proposal for external x-ray beam device (IEC 60601-2-1), creation of the 62C/580/NP standard proposal, proposal of the standardization strategy, and negotiation with the overseas members.Masahiro HIRAOKAGraduated from the Faculty of Medicine, Kyoto University in 1977. After working at the Radiotherapy Seminar, Kyoto University; Stanford University; and others, became Professor of Radiotherapy Lectures, Graduate School of Medicine, Kyoto University in 1995. After working as Unit Leader, Nano-Medicine Merger Education Unit, Kyoto University; Director, Kyoto University Cancer Center; currently works as Deputy Director, Office of Society-Academia Collaboration for Innovation, Kyoto University. In the R&D for motion-tracking radiotherapy and the international standardization activities for 4D radiotherapy, made essential contributions to the creation of the standard proposal for X-IGRT (IEC 60601-2-68), creation of the revised Japanese standard proposal for external x-ray beam device (IEC 60601-2-1), creation of the 62C/580/NP standard proposal pertaining to motion-tracking radiotherapy, proposal of the standardization strategy, and negotiation with the overseas members.Hiroki ShiratoGraduated from the School of Medicine, Hokkaido University in 1981. Worked at the Radiotherapy Division, Hokkaido University Hospital; University of British Columbia; Christie Hospital and University of Manchester; Head Physician, Radiology Department, Obihiro Kosei General Hospital; and Professor, Radiotherapy Department, Graduate School of Medicine, Hokkaido University in 2006. Appointed as Assistant Planner and Manager, Office of the President, Hokkaido University. Currently, Member of Board of Directors, Graduate School, Hokkaido University, as well as Deputy Director, Graduate School of Medicine, Hokkaido University. In the R&D for motion-tracking radiotherapy and the international standardization activities for 4D radiotherapy, made essential contributions to the creation of the standard proposal for X-IGRT (IEC 60601-2-68), creation of the revised Japanese standard proposal for external x-ray beam device (IEC 60601-2-1), creation of the 62C/580/NP standard proposal pertaining to motion-tracking radiotherapy, proposal of the standardization strategy, and negotiation with the overseas members.Discussions with Reviewers1 Overall commentComment (Akira Ono, AIST)This paper clearly illustrates the strategy and results for creating an international standard for 4DRT that was led by Japanese academia and industries. It specifically describes the process by which the draft of the standard was submitted to the IEC. It may lead to updating of existing standards of the IEC or new standards in the future. Also, the Japanese system for drafting the proposal is well described. This would be useful to the readers who plan to become involved in international standardization in the future. I think it is an excellent paper for Synthesiology.2 Significance of international standardizationQuestion (Motoyuki Akamatsu, Human Technology Research Institute, AIST)The motivation for research is written in subchapter 1.2, and it states the social value of this paper. Needless to say, assurance of safety is important, but you state that the international standardization of safety standards is needed as the means to achieve safety. Generally, I feel there are ways to provide safety without such international standardization. Therefore, can you explain why international standardization will ensure safety?Answer (Yuichi Hirata)Specifically, the arbitrary requirements that are internationally standardized by the IEC are mandated and enforced, once they are quoted by the regulatory authority of a country. Therefore, international standardization of the safety requirements of 4DRT system by the IEC is extremely effective to achieve solid safety assurance.3 Agreement among a wide range of stakeholdersComment (Akira Ono)In the process of standardization, the central point is to make an agreement among a wide range of stakeholders involved. In the standardization at the ISO or IEC, since the participating countries may not necessarily have a wide range of stakeholders in their respective countries, the range of agreement could be narrow, which may not make standards widely used after publication.In contrast, in the standardization of the 4DRT equipment discussed in this paper, its characteristic is that wide-ranging stakeholders in Japan were involved. The statements in subchapter 3.3 “International standardization initiated by users” and chapter 5 “Future direction” are appropriate. I think the wide participation of not only the radiotherapy equipment manufacturers but also the equipment users such as physicians, medical technicians, as well as researchers who maintain neutral positions led to the creation of a convincing standard with excellent neutrality. I expect this standard to be adopted worldwide.Answer (Yuichi Hirata)

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