符合基本要求表(Annex I ENG).doc

Annex I Essential Requirements according to Directive 93/42/EEC Name of the Technical file: Issue date of the Technical file: Medical Device: Model(s)/Type(s): Name of the legal manufucturer: Address of the legal manufucturer: Accessories: Date Signature of the manufacturer Date Signature of the Test agency I. GENERAL REQUIREMENTS 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 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. 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 and construction), where appropriate take adequate protection measures including alarms if necessary, in relation to risks that cannot be eliminated, inform users of the residual risks due to any shortcomings of the protection measures adopted. 3. The devices must achieve the performances intended by the manufacturer and be designed, manufactured and packaged in such a way that they are suitable for one or more of the functions referred to in Article 1 (2) (a), as specified by the manufacturer. 4. The characteristics and performances referred to in sections 1, 2 and 3 must not be adversely affected to such a degree that the clinical condition and safety of the patients and, where applicable, of other persons are compromised during the