要 旨 1980 年日本で初めてレーザー手術装置が承認され,のちに医用レーザー機器の普及に努め豊かな福祉社会を培うこと を目的として日本医用レーザ協会が設立された.以降,治験免除基準の策定を始め承認審査の簡素化・迅速化,保険適 応の拡大,レーザー医療の認知と推進,そして医用レーザー機器の安全に関する取組みなど推し進めてきた.特に高度 管理医療機器である医用レーザー機器の安全に対する取組みは,人体に危険とされるレーザー光線をより安全に手術や 治療に適応すべき必要性より,厳しい医療機器の安全基準や規制に関する動向、改定情報、意見集約等の実施と,特定 保守管理医療機器として性能・機能・安全性を維持・管理すべき定期点検の必要性の啓蒙から,現実的な点検内容の紹 介など,より安全なレーザー治療をめざし活動を続けている. キーワード:高度管理医療機器,特定保守管理医療機器,安全管理責任者,安全基準,保守点検,回収情報 Abstract The surgical laser equipment was first approved in Japan in 1980, and later, the

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... pan Medical Laser Association (JMLA) was established with the purpose of promoting the surgical laser equipment to cultivate an enriched welfare society. Since then, the JMLA has devoted itself to simplify and expedite approval procedures including developing a standard for clinical trial exemption, to expand insurance coverage, to gain recognition of and promote medical lasers, and to facilitate activities to enhance safety of medical laser equipment. The JMLA especially focuses on a pursuit of a safer laser treatment using medical laser equipment. Its activities for the safety of the medical laser equipment, as a specially controlled medial device, include consolidating the trends and revision information of and opinions on strict safety standards and regulations of medical equipment. This effort is driven by the needs to safely apply laser beam, which is considered to be hazardous for the human body, in operations and treatments. The JMLA also inform its members realitybased maintenance information as a part of education to understand the needs of routine maintenance in order to maintain and control the medical laser equipment at its best performance, functionality and safety level as a specially designated maintenance-control-required medical device.