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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 |
312 | 23.2(l) | | (l) if the device is supplied sterile, an indication of its sterile state and the sterilisation method; | | (l) 無菌で供給される場合、無菌状態である旨、及び滅菌方法 | | 313 | 23.2(m) | | (m) warnings or precautions to be taken that need to be brought to the immediate attention of the user of the device, and to any other person. This information may be kept to a minimum in which case more detailed information shall appear in the instructions for use, taking into account the intended users; | | (m) すぐに注意を引くように提供する必要がある警告や注意事項 | | 314 | 23.2(n) | | (n) if the device is intended for single use, an indication of that fact. A manufacturer's indication of single use shall be consistent across the Union; | | (n) 単回使用を意図したものの場合、その旨 | | 315 | 23.2(o) | | (o) if the device is a single-use device that has been reprocessed, an indication of that fact, the number of reprocessing cycles already performed, and any limitation as regards the number of reprocessing cycles; | | (o) 再処理された単回使用機器の場合、その旨、既に行なわれた再処理の回数、及び再処理の回数の制限 | | 316 | 23.3(p) | | (p) if the device is custom-made, the words ‘custom-made device’; | | (p) 特注のものの場合、‘custom-made device’
| | 317 | 23.2(q) | | (q) an indication that the device is a medical device. If the device is intended for clinical investigation only, the words ‘exclusively for clinical investigation’; | | (q) 医療機器である旨、また臨床試験用のものの場合は ‘exclusively for clinical investigation’ | | 318 | 23.2(r) | | (r) in the case of devices that are composed of substances or of combinations of substances that are intended to be introduced into the human body via a body orifice or applied to the skin and that are absorbed by or locally dispersed in the human body, the overall qualitative composition of the device and quantitative information on the main constituent or constituents responsible for achieving the principal intended action; | | (r) 体表開口部や皮膚を介して人体に与えられる、人体に吸収もしくは局所的に分散する物質を含む 場合、その機器全体の定量的組成、及び主に意図された作用のための主成分に関する情報 | | 319 | 23.2(s) | | (s) for active implantable devices, the serial number, and for other implantable devices, the serial number or the lot number. | | (s) 植え込み機器の場合、製造番号かロット番号 | | 400 | 23.3 | The following particulars shall appear on the sterile packaging: | | 機器の無菌状態を維持する包装上の情報
| | | 401 | 23.3(a) | | (a) an indication permitting the sterile packaging to be recognised as such, | | (a) 無菌包装であることを認識できる情報
| | 402 | 23.3(b) | | (b) a declaration that the device is in a sterile condition, | | (b) 機器が無菌状態である旨の宣言
| | 403 | 23.3(c) | | (c) the method of sterilisation, | | (c) 滅菌方法 | | 404 | 23.3(d) | | (d) the name and address of the manufacturer, | | (d) 製造業者の住所と名前 | | 405 | 23.3(e) | | (e) a description of the device, | | (e) 機器の説明 | | 406 | 23.3(f) | | (f) if the device is intended for clinical investigations, the words ‘exclusively for clinical investigations’, | | (f) 臨床試験用のものの場合、‘exclusively for clinical investigation’ | |