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TUVRH德国莱茵CE认证文件模板
Risk Analysis 风 险 分 析 | | | | | | | | | | | | | 所有可识别的风险都已经被评估。在采取适当的措施以降低这些风险之后,关于产品预期的应用和用途上,各种等级的风险是可以接受的。 All risks associated with the identified hazards have been evaluated. After appropriate measures to reduce these risks have been taken, the overall level of risk of the product is acceptable with regard to the intended application and use of the application. |
编写Compiled by: (Name/Title/Dept.) | | 日期Date: | | 评审Reviewed by (Name/Title/Dept.) | | 日期Date: | | 批准Approved by: (Name/Title/Dept.) | | 日期Date: | |
特征的定性定量分析:(acc. to ISO 14971:2000, cl. 4.2) Identificationof qualitative and quantitative characteristics (acc. to ISO 14971:2000, cl.4.2) 1 | 预期用途和怎样使用:Intended use and how to use | | | 是否接触病人或其他人:Intended to contact patient or other person | | | 所用的元件/材料:Materials/components used | | | 能量给予/源于病人: Energy to/from patient | | | 物质给予/源于病人: Substances to /from patient | | | 被加工的生物材料: Biological materials processed | | | 灭菌/用户灭菌或其它微生物控制:Sterile/Intended to be sterilized | | | 用户是否需日常清洁或消毒: routinely cleaned and disinfected by the user | | | 改变病人环境:Modify patient environment | | | | | | 器械输出的数据解释: Interpretative | | | 是否与其它药物或医疗技术联用:use in conjunction with medicines or other medical technologies | | | 不需要的能量或物质输出:Unwanted outputs of energy or substances | | | 受环境影响:(操作、运输的存储的环境,包括溢出,电能和冷却提供)Susceptible to environmental influences | | [hide=d999999]
TUVRH文件样本.rar
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