基于2007 47 EC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基于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: 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 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
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)
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)
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, 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 ergonomi