は性能（以下この（２）において「使用方法等」という。）と異なる使用方 法等で用いる場合に限り、（３）に該当する場合を除く。） 2. Use of medical devices that have been approved pursuant to Article 23- 2-5, paragraph (1) or Article 23-2-17, paragraph (1) of the Act on  Pharmaceuticals and Medical Devices (including approval for changes  pursuant to Article 23-2-5, paragraph (15) of the Act on  Pharmaceuticals and Medical Devices (including the case applied  mutatis mutandis in Article 23-2-17, paragraph (5) of the Act on  Pharmaceuticals and Medical Devices); the same applies in 2.), that  have been certified pursuant to Article 23-2-23, paragraph (1) of the  Act on Pharmaceuticals and Medical Devices (including certification  for changes pursuant to paragraph (7) of the same Article; the same  applies in 2.), or that have been notified pursuant to the provisions of  Article 23-2-12, paragraph (1) of the Act on Pharmaceuticals and  Medical Devices (including notification for changes pursuant to  paragraph (2) of the same Article; the same applies in 2.) (excluding  cases falling under 3. when the medical devices are used for other  purpose of use, efficacy, or effects (hereinafter referred to as "usage,  etc." in 2.) than those pertaining to the approval, certification, or  notification)  （３） 禁忌又は禁止に該当する医療機器の使用 3. Use of contraindicated or prohibited medical devices  三の二 診療用放射線に係る安全管理のための体制の確保に係る措置として、診療用 放射線の利用に係る安全な管理（以下「安全利用」という。）のための責任者を配 置し、次に掲げる事項を行わせること。 (iii)-2 As measures to ensure the system for safety management of medical  radiation, a person responsible for the safety management on the use  (hereinafter referred to as "safe use") of medical radiation will be appointed  to have the person preform the following matters.  イ 診療用放射線の安全利用のための指針の策定 (a) Formulation of guidelines for the safe use of medical radiation  ロ 放射線診療に従事する者に対する診療用放射線の安全利用のための研修の実施 (b) Providing training for the safe use of medical radiation to persons  engaged in radiation treatment  ハ 次に掲げるものを用いた放射線診療を受ける者の当該放射線による被ばく線量 の管理及び記録その他の診療用放射線の安全利用を目的とした改善のための方策 の実施 (c) Taking improvement measures for the management and records of the  radiation exposure dose of persons who receive radiation treatment using  any of the following items and for the safe use of medical radiation  （１） 厚生労働大臣の定める放射線診療に用いる医療機器 28 