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MDR ABBEX Ⅰ 要求事項 |
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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 |
407 | 23.3(g) | | (g) if the device is custom-made, the words ‘custom-made device’, | | (g) 特注のものの場合、‘custom-made device’
| | 408 | 23.3(h) | | (h) the month and year of manufacture, | | (h) 製造の月と年 | | 409 | 23.3(i) | | (i) an unambiguous indication of the time limit for using or implanting the device safely expressed at least in terms of year and month, and | | (i) その機器を安全に使用/移植できる期限の曖昧でない表示 | | 410 | 23.3(j) | | (j) an instruction to check the instructions for use for what to do if the sterile packaging is damaged or unintentionally opened before use. | | (j) 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対応は使用指示書を確認すべき旨の指示 | | 500 | 23,4 | | The instructions for use shall contain all of the following particulars: | 使用指示書上の情報
| | | 501 | 23.4(a) | | (a) the particulars referred to in points (a), (c), (e), (f), (k), (l), (n) and (r) of Section 23.2; | | (a) 「ラベル上の情報」の項目 (a)、(c)、(e)、(f)、(k)、(l)、(n) 及び (r)
| | 502 | 23.4(b) | | (b) the device's intended purpose with a clear specification of indications, contra-indications, the patient target group or groups, and of the intended users, as appropriate; | | (b) 適応症、禁忌、対象となる患者や患者群、及び意図された使用者の明確な規定を含む、機器の意 図された目的 | | 503 | 23.4(c) | | (c) where applicable, a specification of the clinical benefits to be expected. | | (c) 該当する場合、予期される臨床的ベネフィット | | 504 | 23.4(d) | | (d) where applicable, links to the summary of safety and clinical performance referred to in Article 32; | | (d) 該当する場合、安全/臨床性能の要約への参照 | | 505 | 23.4(e) | | (e) the performance characteristics of the device; | | (e) その機器の性能特性 | | 506 | 23.4(f) | | (f) where applicable, information allowing the healthcare professional to verify if the device is suitable and select the corresponding software and accessories; | | (f) 該当する場合、医療専門家がその機器が適切であることを確認し、対応するソフトウェアや付属 品を選択できるような情報 | | 507 | 23.4(g) | | (g) any residual risks, contra-indications and any undesirable side-effects, including information to be conveyed to the patient in this regard; | | (g) 患者に伝えるべき情報を含む、残留リスク、禁忌、及び望ましくない副作用 | | 508 | 23.4(h) | | (h) specifications the user requires to use the device appropriately, e.g. if the device has a measuring function, the degree of accuracy claimed for it; | | (h) 機器を正しく使うために必要な仕様、例えば測定機能を持つ場合は精度 | | 509 | 23.4(i) | | (i) details of any preparatory treatment or handling of the device before it is ready for use or during its use, such as sterilisation, final assembly, calibration, etc., including the levels of disinfection required to ensure patient safety and all available methods for achieving those levels of disinfection; | | (i) 滅菌、組み立て、校正などの、使用前の準備作業や取り扱いの詳細 | | 510 | 23.4(j) | | (j) any requirements for special facilities, or special training, or particular qualifications of the device user and/or other persons; | | (j) 特別な施設、訓練、あるいは資格の要求 | |