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"通常伴隨著技術的設備，並解釋如何安裝或操作手冊" 基本要求 — — 醫療設備指令 93年/42/EEC-附件一的第 13.1： 的每個設備必須附有所需安全使用並找出與製造商聯繫，考慮到培訓和知識的潛在使用者的資訊。此資訊包括有關標籤的詳細資訊和使用中的說明進行操作的資料。在可行和適當的情況下，安全地使用該設備所需的資訊必須設置設備本身和/或包裝的每個單元。如果不可行的情況下，資訊必須列明在單張提供與一個或多個設備。使用 說明必須包括在每個設備的包裝。作為例外，沒有這種說明書需要設備 I 類或 IIa 類如果他們可以沒有任何此類指示完全安全地使用。
Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; Category: Biochemistry; Biofuel; Biomedical; Behavioral science; Cancer treatment; Dentistry; Diseases; Hematology; Hospitals; Medical research; Nursing homes; Psychiatry; Vaccines; Regulatory; Herbal medicine; Histology; Medicine; Cardiac supplies; Clinical analytical instruments; Clinical trials; Dental equipment; Dermatology instruments; Emergency room apparatus; ENT instruments; Eye instruments; General assay & diagnostic instruments; Implants & interventional materials; Medical cryogenic equipment; OBGYN equipment; Orthopaedic supplies; Pharmacology instruments; Physical therapy equipment; Radiology equipment; Sterilization equipment; Surgical instruments; Ultrasonic & optical equipment; Ward nursing equipment
Gebrauchsanweisung
Domain: Biotechnology; Health care; Life Sciences; Medical; Medical devices; Regulatory; Category: Biochemistry; Biofuel; Biomedical; Behavioral science; Cancer treatment; Dentistry; Diseases; Hematology; Hospitals; Medical research; Nursing homes; Psychiatry; Vaccines; Regulatory; Herbal medicine; Histology; Medicine; Cardiac supplies; Clinical analytical instruments; Clinical trials; Dental equipment; Dermatology instruments; Emergency room apparatus; ENT instruments; Eye instruments; General assay & diagnostic instruments; Implants & interventional materials; Medical cryogenic equipment; OBGYN equipment; Orthopaedic supplies; Pharmacology instruments; Physical therapy equipment; Radiology equipment; Sterilization equipment; Surgical instruments; Ultrasonic & optical equipment; Ward nursing equipment
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