风险管理控制程序(符合MDR要求的中英文版).docxVIP

PROGRAM FILES No.： HY/CX-26 Rev. ： A/4 Risk Management Control Procedures Effective Date： 2021-09-28 Drafted by：Reviewed by： Approved by： Risk Management Control Procedures Purpose 目的 In order to standardize and effectively manage the risk management activities of medical device products in the company, this procedure is specially formulated. 对公司内医疗器械产品的风险管理活动进行规范和有效的管理，特制定本程序。 Scope 范围 It is suitable for risk analysis and management of medical devices produced by the company. 适用于公司内所有的医疗器械产品的风险分析和管理。 Reference参考文件 EN ISO 14971： 2019《Medical devices 一 Application of Risk Management to Medical Devices》 ISO/TR 24971:2020 （Medical devices 一 Guidance on the Application of ISO 14971^ Definition 定义 Risk: combination of the probability of occurrence of harm and the severity of that harm. 风险：伤害的发生概率与严重程度的结合。 Hazard: Potential source of harm. 危险：可能导致伤害的潜在源。 Harm: injury or damage to the health of people, or damage to property or the environment. 损害：对人体的伤害或损坏，或是对财产或环境的损坏。 Hazardous Situations: circumstance in which people, property or the environment is/are exposed to one or more hazards. 危险情况：人员、财产或环境处于一个或多个危险（源）中。 Life-cycle: series of all phases in the life of a medical device, from initial concept to final decommission and disposal. 生命周期：在医疗器械生命中，从初始概念到最终停用和处置的所有阶段。 Residual risk: risk remaining after risk control measures have been implemented. 剩余风险：实施风险控制措施后还存在的风险。 documentation shall be maintained in the risk management file. 公司应识别并记录可能影响医疗器械平安的定性和定量特征并形成文件。适当时，规定界限。 此信息应保存在风险管理文档中。 Identification of hazards and hazardous situations 危险(源)和危险情况的识别 The manufacturer shall identify and document known and foreseeable hazards associated with the medical device based on the intended use , reasonably foreseeable misuse and the characteristics related to safety in both normal and fault conditions. 公司应根据正常和故障条件下，基于预期用途、合理可预见性误用以及与平安有关的特征识 别，记录与医疗器械有关的和可预见的危险。 For each identified hazard, the manufacturer shall consider the reasonably foreseeable sequences or combinations of event