Home > Blossary: Instructions for use
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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 ...
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