ISO 13485

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This International Standard specifies requirements for a qualitymanagement system that can be used by an organization involved in one or morestages of the life-cycle of a medical device, including design and development,production, storage and distribution, installation, servicing and finaldecommissioning and disposal of medical devices, and design and development, orprovision of associated activities (e.g. technical support).

本标准规定了质量管理体系要求，涉及医疗器械生命周期的一个或多个阶段的组织能依此要求进行医疗器械的设计和开发、生产、贮存和流通、安装、服务和最终停用及处置，以及相关活动（例如技术支持）的设计和开发或提供。

The requirements in this International Standard can also be used bysuppliers or other external parties providing product (e.g. raw material,components, subassemblies, medical devices, sterilization services, calibrationservices, distribution services, maintenance services) to such organizations.The supplier or external party can voluntarily choose to conform to therequirements of this International Standard or can be required by contract toconform.

本标准的要求也能用于向这种组织提供产品（例如原材料、组件、部件、医疗器械、灭菌服务、校准服务、流通服务、维护服务）的供方或其他外部方。该供方或外部方能自愿选择符合本标准的要求和按照合同要求符合本标准的要求。

wang121

so??????????????你要表达啥

kimpirateyyc

水贴？                          

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