0747EC基本要求(V1.1).docVIP

I . GENERAL REQUIREMENTS 基本要求-一般要求 1 The devices must be designed and manufactured in such a way that, when used under the conditions and for the purposes intended, they will not compromise the clinical condition or the safety of patients, or the safety and health of users or, where applicable, other persons, provided that any risks which may be associated with their intended use constitute acceptable risks when weighed against the benefits to the patient and are compatible with a high level of protection of health and safety. 器械的設計和製造必須使其在按預定用途和常規條件下使用時，不會危及患者的臨床狀況或安全，或使用者，必要時也包括其他人的安全和健康，並證明在妨礙到患者利益時，器械使用中可能出現的危險均爲可接受的，且器械與高水準的健康和安全保護相一致 This shall include: 包括: － reducing, as far as possible, the risk of use error due to the ergonomic features of the device and the environment in which the device is intended to be used (design for patient safety), and － 盡可能減少由於器械工程學特徵和器械預定使用環境（爲病人的健康而設計）而導致的使用錯誤的危險，和 － consideration of the technical knowledge, experience, education and training and where applicable the medical and physical conditions of intended users (design for lay, professional, disabled or other users). － 考慮技術知識、經驗、教育和培訓和預定使用的醫療和實際情況（爲佈置人員、專業人員、殘疾人員或其他使用者所設計） Apply Y/N Response回覆Observations意見（Standard / Procedure / Documentation） (if necessary, continue on blank page)如果需要，繼續寫在空白頁 OK / Fail 2 The solutions adopted by the manufacturer for the design and construction of the devices must conform to safety principles, taking account of the generally acknowledged state of the art. In selecting the most appropriate solutions, the manufacturer must apply the following principles in the following order: 考慮到一般公認的技術狀況，製造商採用的器械設計和構造方法必須符合安全原則。 在選擇最適當的方法時，製造商須依次適用以下原則： － eliminate or reduce risks as far as possible (inherently safe design and construction) , － 盡可能消除或降低危險（固有的安全設計和構造）； － where appropriate take adequate protection measures including alarms if necessary, in relation to risks that cannot be eliminated, － 對不可能被消除的危險，在必要情況下，應採取適當的保護措施，包括必要的警告；