一 受託業務の責任者として、滅菌消毒の業務（以下「滅菌消毒業務」という。）に 関し相当の経験を有する医師、歯科医師、薬剤師、看護師、歯科衛生士、臨床検査 技師又は臨床工学技士を有すること。ただし、病院、診療所又は助産所の施設で滅 菌消毒業務を行う場合は、滅菌消毒業務に関し相当の知識及び経験を有する者を受 託業務の責任者とすることができる。 (i) A physician, dentist, pharmacist, nurse, dental hygienist, clinical laboratory  technician, or clinical engineer with considerable experience in the services  of sterilization and disinfection (hereinafter referred to as "sterilization and  disinfection services") has been secured as a person responsible for entrusted  services. However, when providing sterilization and disinfection services in a  hospital, clinic, or birthing center, a person with considerable knowledge and  experience in sterilization and disinfection services may be appointed as a  person responsible for entrusted services.  二 受託業務の指導及び助言を行う者として、滅菌消毒業務に関し相当の知識及び経 験を有する医師等を選任していること。ただし、病院、診療所又は助産所の施設で 滅菌消毒業務を行う場合は、この限りでない。 (ii) A physician, etc. with considerable knowledge and experience in  sterilization and disinfection services has been appointed as a person who  provides instruction and advice on entrusted services. However, this does not  apply when sterilization and disinfection services are provided in facilities of  a hospital, clinic, or birthing center.  三 従事者として、滅菌消毒の処理に使用する機器の取扱いその他の受託業務を行う ために必要な知識及び技能を有する者を有すること。 (iii) A person with knowledge and skills necessary for handling devices used in  sterilization and disinfection processes and for providing entrusted services  has been secured as a person engaging in services.  四 構造設備が安全かつ衛生的であること。 (iv) The buildings and equipment are safe and sanitary.  五 滅菌消毒作業室、繊維製品の洗濯包装作業室、滅菌又は消毒済みの医療機器又は 繊維製品の保管室が区分されていること。 (v) The sterilization and disinfection room, room for cleaning and packaging  textile products, and room for storing sterilized or disinfected medical  devices or textile products are separated.  六 滅菌消毒作業室は、受託業務を適切に行うことができる十分な広さ及び構造を有 すること。 (vi) The sterilization and disinfection room has a sufficient space and structure  to provide entrusted services appropriately.  七 滅菌消毒作業室の機器及び設備は、作業工程順に置かれていること。 (vii) The devices and equipment in the sterilization and disinfection room are  placed in order of operation process.  八 滅菌消毒作業室の床及び内壁の材料は、不浸透性材料（コンクリート、タイル等 79 