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1、 基于200747EC法规的基本要求检查表93/42/EEC including 2007/47/ECAnnex IEssential Requirements Checklist93/42/EEC 包括 2007/47/EC附录一 基本要求检查表 Product name: Ultrasonic scaler产品名： Type(s)/Model(s): K08类型/型号Product group: Ultrasonic scaler; Handpiece; Scaler tip;产品族Issue date of Technical File: 技术文档发布日： Revision of Tec
2、hnical 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Accessories: 附件：Date 日期 Name Reviewer 1/审核人1的名字 Signature Reviewer 1/审核人1签字Date日期 Name Reviewer 2/审核人2的名字 Signature Reviewer 2/审核人2签字Checklist according to annex I of the Medical Device Directive (MDD)
3、 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)Requirements fulfilled ( to be filled in by Notified Body)
4、要求满足(由公告机构填写)Ok /Fail符合 /不符合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, w
5、here 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
6、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 tec
7、hnical 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预期使用的环境（为患者安全设计的）的错误使用而产生的风险， 和 考虑技术知识、经验、教育和培训，预期用户（为非专业人员、专业人员、伤残人员或其他人）的医疗和身体条件。Checklis
8、t 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
9、或不适用的理由)Requirements fulfilled ( to be filled in by Notified Body) 要求满足 (由公告机构填写)Ok / Fail 符合 / 不符合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
10、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
11、 that cannot be eliminated, Inform users of the residual risks due to any shortcomings of the protection measures adopted.制造商采用的器械结构和设计方案，必须考虑在当前工艺技术条件下遵守安全原则。在选择最合适方案时，制造商应按照以下顺序遵守原则： 尽可能地降低或避免风险（固有的安全设计和结构） 对无法避免的风险，如适用，采取适当的防护措施，包括必要的报警。 告知用户由于所提供防护措施的缺陷而带来的残留风险。3. The devices must achieve the pe
12、rformances 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. 器械最后必须取得制造商期望获得的功能。器械设计、制造和包装应与第1条(2)(a)制造商所规定的一项或多项功能相适应。Checklist according t
13、o 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)Requi
14、rements fulfilled ( to be filled in by Notified Body) 要求满足 (由公告机构填写)Ok / Fail 符合 / 不符合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 lifetime of the device as indicated by the manufacturer, when the device is subjected to the stresses which can occur during normal conditions of use. 在制造商确定的器械使用寿命期内，在正常使用可能出现的压力下，第1，2，3款指的各项特征和性能应不能影响临床条件、危害患者或其它人员的安全。 5. The dev
