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医疗器械. 质量管理体系. 管制目的要求

Medical devices. Quality management systems. Requirements for regulatory purposes

医疗产品 风险管理在医疗器械中的应用

Medical devices. Application of risk management to medical devices

风险管理 ISO 31000 实施指南

Risk management. Guidance for the implementation of ISO 31000

国际医疗器械标准中安全方面的发展和融合指南

Guide to the development and inclusion of safety aspects in international standards for medical devices

医疗电气美利体育官网首页网址. 带超声和荧光内窥镜用装置的内窥镜检查显像复合体. 政府采购规范

Medical electrical equipment. Videoendoskopic complexes with installations for ultrasonic and fluorescence endoscopy. Specifications for governmental purchase

健康信息学. 医疗器械IT网络的风险管理. 第2-1部分. 医疗IT网络的步进式风险管理. 实际应用和实例

Health infornatics. Risk management for IT-networks incorporating medical devices. Part 2-1. Step-by-step risk management of medical IT-networks. Practical applications and examples

健康信息学. 健康软件安全标准指南

Health informatics. Guidance on standards for enabling safety in health software

新技术使用的风险管理. 第2部分. 新技术应用

Risk management of new technologies using. Part 2. Application to new technologies

新技术使用的风险管理. 第4部分. 新生产和生产网络应用

Risk management of new technologies using. Part 4. Application to new production and production networks

新技术使用的风险管理. 第7部分. 影响风险出现的因素示例

Risk management of new technologies using. Part 7. Examples of factors influencing emergence of risk

飞机美利体育官网首页网址 通过生命周期阶段的质量保证风险管理 不确定性分类领域

Aircraft equipment. Risk management for quality assurance through life cycle stages. Areas of uncertainty classification

医疗产品 风险管理 产品生命周期生产后阶段的风险评估

Medical devices. Risk management. Post-production risk assessment of life cycle of products

医疗产品 风险管理 风险分析和评估流程规划指南

Medical devices. Risk management. Guide for risk analysis and risk assessment process planning

医疗产品 风险管理 准备和更新风险管理报告的指南

Medical devices. Risk management. Guidelines for the preparation and updating of a risk management report

根据 IEC 60601-2-66 的产品要求和测试概述

Summary of requirements and tests to products in the scope of IEC 60601-2-66

项目管理. 设计中的风险管理应用指南

Project management. Guidance on the application of risk management in the design

风险管理 以航天系统为例的概率风险评估方法

Risk management. Probabilistic risk assessment method on example of space systems

包含人体活性细胞的医疗产品. 风险管理应用和处理实践要求

Medical products containing viable human cells. Application of risk management and requirements for processing practices

吸入麻醉和人工肺通气装置 氧气相容性

Anaesthetic and respiratory equipment. Compatibility with oxygen

风险管理 企业火灾风险管理工作程序

Risk management. Fire risk management in enterprise

医学实验室 风险管理在医学实验室中的应用

Medical laboratories. Application of risk management to medical laboratories

风险管理 原则和指南

Risk management. Principles and guidelines