200747EEC法规的基本要求检查表.doc

基于2007/47/EC法规的基本要求检查表 93/42/EEC including 2007/47/EC Annex I Essential Requirements Checklist 93/42/EEC 包括 2007/47/EC 附录一 基本要求检查表 Product name: 产品名： Type(s)/Model(s): 类型/型号 Product group: 产品族 Issue date of Technical File: 技术文档发布日： Revision of Technical File: 技术文档修订版本： Legal Manufacturer: 法定制造商 Name 名字 Street 街道 Postal code邮编 Place地点 Country 国家 Checklist according to annex I of the Medical Device Directive (MDD) 按医 疗 器 械 指 令 （MDD） 附 录 一 的 基 本 要 求 检 查 表 A/ NA 适用/不适用 Standards, other directives and other rules applied by manufacturer 制造商引用的标准，其它指令或规则 Documentation (test reports, protocols, literature or reason for no applicability) 支持性文件(测试报告，方案，文献或不适用的理由) I. General Requirements 通用 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. 器械的生产和设计必须保证：按照其预定用途和条件使用，器械不会损害临床条件、或患者安全、或操作者或其他人员的安全和健康；假设与器械预期用途相关的任何风险，与之给患者带来的益处相比，并与健康安全的保护程度相一致，则是可接受的。 This shall include: ? 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 ? 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). 应包括： ? 尽可能地降低由于器械的人体工学特征和器械