CE基本要求检查表样稿.pdf

Technical Documents Essential Requirements Check-list Ver. A Essential Requirements (ERs) Check-list A or ER Description Standard Manufacture’s Compliance Location N/A I. GENERAL REQUIREMENTS 1 The devices must be designed and manufactured in such a way that, A EN ISO13485:2003 Design documents CE-BW23-5-005 when used under the conditions and for the purposes intended, they will EN ISO14971:2000 Risk management report 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 use constitute acceptable risks when weighed against the benefits to the patient and are Test report compatible with a high level of protection of health and safety. 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: - eliminate or reduce risks as far as possible (inherently safe design