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医疗产品 软件 生命周期流程

Medical devices. Software. Life cycle processes

医疗产品 评估医疗器械的生物效应 第1部分 风险管理过程的评估与研究

Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing within a risk management process

医疗产品 评估医疗器械的生物效应 第10部分：敏感性研究

Medical devices. Biological evaluation of medical devices. Part 10. Sensitization tests

医疗产品 评估医疗器械的生物效应 第18部分：作为风险管理流程一部分的材料化学特性调查

Medical devices. Biological evaluation of medical devices. Part 18. Chemical characterization of medical device materials within a risk management process

医疗产品 评估医疗器械的生物效应 第9部分：识别和量化潜在降解产物的基本原则

Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products

保健品灭菌 环氧乙烷 医疗器械灭菌过程的开发、验证和常规控制要求

Sterilization of health-care products. Ethylene oxide. Requirements for the development, validation and routine control of a sterilization process for medical devices

最终灭菌医疗器械的包装 第1部分：材料、无菌屏障系统和包装系统的要求

Packaging for terminally sterilized medical devices. Part 1. Requirements for materials, sterile barrier systems and packaging systems

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

医疗美利体育官网首页网址 医疗器械的生物学评价 第22部分 纳米材料指南

Medical devices. Biological evaluation of medical devices. Part 22. Guidance on nanomaterials

医疗产品 安全要求 卫生化学和毒物学试验方法

Medical devices. Evaluation system of biological effects. Part 1. General requirements for biological safety

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

医疗器械. 临床评估

Medical devices. Clinical evaluation

质量管理体系. 医疗器械. 从供应商处获得的产品和服务的控制指南

Quality management system. Medical devices. Guidance on the control of products and services obtained from suppliers

用于监管当局认可的医疗美利体育官网首页网址审计组织的要求

Requirements for medical device auditing organizations for regulatory authority recognition

医疗器械. 工业生产规范

Medical equipment. Industrial production regulation

医疗用途的灭菌器 环氧乙烷灭菌器 要求及测试方法

Sterilizers for medical purposes. Ethylene oxide sterilizers. Requirements and test methods

保健品杀菌 湿热 第3部分 医疗器械产品系列和蒸汽灭菌加工类别的指南

Sterilization of health care products. Moist heat. Part 3. Guidance on the designation of a medical device to a product family and processing category for steam sterilization

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

医疗美利体育官网首页网址 生产商在产品放行流通后使用的监控系统

Medical devices. The monitoring system used by the manufacturer after the release of products in circulation

合格评定 ISO/IEC 17021-1在医疗器械质量管理体系领域的应用（ISO 13485）

Conformity assessment. Application of ISO/IEC 17021-1 in the field of medical device quality management systems (ISO 13485)

医疗电气美利体育官网首页网址 微波治疗美利体育官网首页网址 技术条件控制方法

Medical electrical equipment. Microwave therapy equipment. Technical condition control methods

一次性吸收尿布 通用技术条件

Absorbent underwear for disabled children. General specifications

人类受试者使用医疗器械的临床研究. 良好临床实践

Clinical investigation. Good clinical practice

用于医疗的液体和气体小直径接头 第3部分：肠内应用接头的特殊要求

Small-bore connectors for liquids and gases in healthcare applications. Part 3. Particular requirements for connectors for enteral applications