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No 項番 タイトル（E) 要求事項（E) タイトル（J) 要求事項（J) コマンド
51123.4(k)(k) the information needed to verify whether the device is properly installed and is ready to perform safely and as intended by the manufacturer, together with, where relevant: — details of the nature, and frequency, of preventive and regular maintenance, and of any preparatory cleaning or disinfection, — identification of any consumable components and how to replace them, — information on any necessary calibration to ensure that the device operates properly and safely during its intended lifetime, and — methods for eliminating the risks encountered by persons involved in installing, calibrating or servicing devices; (k) 機器が正しく設置され安全かつ意図したように動作できるかどうかを確認するために必要な情報; 該当する場合、予防/定期保守、また予備洗浄や消毒の内容の詳細やその頻度、消耗品とその交換 方法、必要な校正、機器の設置、校正、または保守に伴うリスクの除去の方法
51223.4(l)(l) if the device is supplied sterile, instructions in the event of the sterile packaging being damaged or unintentionally opened before use; (l) 無菌状態で供給される場合、無菌包装が損なわれた、あるいは使用前に意図せずに開けられた時の指示
51323.4(m)(m) if the device is supplied non-sterile with the intention that it is sterilised before use, the appropriate instructions for sterilisation; (m) 使用前に滅菌することを意図して非無菌状態で供給される場合、滅菌の適切な指示
51423.4(n)(n) if the device is reusable, information on the appropriate processes for allowing reuse, including cleaning, disinfection, packaging and, where appropriate, the validated method of re-sterilisation appropriate to the Member State or Member States in which the device has been placed on the market. Information shall be provided to identify when the device should no longer be reused, e.g. signs of material degradation or the maximum number of allowable reuses; (n) 再使用可能なものの場合、洗浄、消毒、包装、及び該当する場合は滅菌方法のバリデーションの 方法を含む、再使用を可能とするための適切な処理の情報、及びもはや再使用すべきでないことを同定するための情報
51523.4(o)(o) an indication, if appropriate, that a device can be reused only if it is reconditioned under the responsibility of the manufacturer to comply with the general safety and performance requirements; (o) 該当する場合、製造業者の責任のもとで再処理された場合に限りその機器を再使用できる旨
51623.4(p)(p) if the device bears an indication that it is for single use, information on known characteristics and technical factors known to the manufacturer that could pose a risk if the device were to be re-used. This information shall be based on a specific section of the manufacturer's risk management documentation, where such characteristics and technical factors shall be addressed in detail. If in accordance with point (d) of Section 23.1. no instructions for use are required, this information shall be made available to the user upon request; (p) 単回使用用である旨が示されている場合、それが再使用された時にリスクをもたらし得ると知っている既知の特性や技術的要素の情報
51723.4(q)(q) for devices intended for use together with other devices and/or general purpose equipment: — information to identify such devices or equipment, in order to obtain a safe combination, and/or — information on any known restrictions to combinations of devices and equipment; (q) 他の機器と組み合わせて使うことが意図された機器の場合、そのような機器を同定する情報、及 び/もしくは機器の組み合わせの制約の情報
51823.4(r)(r)if the device emits radiation for medical purposes: — detailed information as to the nature, type and where appropriate, the intensity and distribution of the emitted radiation, — the means of protecting the patient, user, or other person from unintended radiation during use of the device; (r) 医療の目的で放射を発生する場合、放射の性質、種類、及び該当する場合は強度や分布の詳細な 情報、また患者、使用者、その他の者を意図しない放射から保護する方法
51923.4(s)(s)information that allows the user and/or patient to be informed of any warnings, precautions, contra- indications, measures to be taken and limitations of use regarding the device. That information shall, where relevant, allow the user to brief the patient about any warnings, precautions, contra-indications, measures to be taken and limitations of use regarding the device. The information shall cover, where appropriate: (s) 警告、注意事項、禁忌、講じるべき手段と使用上の制限を使用者や患者に知らせるための情報
52023.4(s)-1warnings, precautions and/or measures to be taken in the event of malfunction of the device or changes in its performance that may affect safety, i. 機器の誤動作や安全に影響するかも知れない性能の変化の際の警告、注意事項、及び/もしく は講じるべき手段
52123.4(s)-2warnings, precautions and/or measures to be taken as regards the exposure to reasonably foreseeable external influences or environmental conditions, such as magnetic fields, external electrical and electromagnetic effects, electrostatic discharge, radiation associated with diagnostic or therapeutic procedures, pressure, humidity, or temperature, ii. 磁界、外部の電気的/電磁的影響、静電気放電、診断や治療に伴う放射、圧力、湿度、温度な どの合理的に予見可能な外的な影響や環境条件への曝露に関する警告、注意事項、及び/もし くは講じるべき手段
52223.4(s)-3 warnings, precautions and/or measures to be taken as regards the risks of interference posed by the reasonably foreseeable presence of the device during specific diagnostic investigations, evaluations, or therapeutic treatment or other procedures such as electromagnetic interference emitted by the device affecting other equipment, iii. その機器の存在によってもたらされるかも知れない干渉に関する警告、注意事項、及び/もし くは講じるべき手段
52323.4(s)-4 if the device is intended to administer medicinal products, tissues or cells of human or animal origin, or their derivatives, or biological substances, any limitations or incompatibility in the choice of substances to be delivered, iv. ヒトや動物に由来する医薬品、組織や細胞やその派生物、あるいは生体物質の投与を意図し たものの場合、投与される物質の選択における制限や不適合性
52423.4(s)-5warnings, precautions and/or limitations related to the medicinal substance or biological material that is incorporated into the device as an integral part of the device; and 機器の不可欠な部分として機器に組み込まれている医薬物質または生物学的材料に関連する警告、注意事項、および/または制限;
52523.4(s)-6 precautions related to materials incorporated into the device that contain or consist of CMR substances or endocrine-disrupting substances, or that could result in sensitisation or an allergic reaction by the patient or user; CMR物質または内分泌かく乱物質を含むまたはそれらから構成される、または患者またはユーザーによる感作またはアレルギー反応を引き起こす可能性のある、機器に組み込まれた材料に関連する予防措置
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