【英语版】国际标准 ISO 14971-1:1998 EN 医疗器械 风险管理 第1部分:风险分析的应用 Medical devices — Risk management — Part 1: Application of risk analysis.pdf,ISO 14971-1:1998 EN Medical devices — Risk management — Part 1: Application of risk analysis
What is ISO 14971? ISO 14971:2000 (“Medical Devices - Application of Risk Management to Medical Devices) is an internationally recognized standard used by 4 manufacturers as a tool for conducting risk assessment. The U.S. Food and Drug Administration (FDA) recognizes it as an acceptable risk...
ISO 14971 is the key to effective risk management for medical devices.ISO 14971 is the risk management standard for medical devices. This includes software as a medical device and in vitro diagnostic medical devices. It contains a structured approach for effective medical device risk management....
Consequently, the purpose of this paper is to elaborate the importance of ISO 14971 – medical devices risk management standard, in the medical world. Beginning with a succinct introduction, the paper clearly provides scrutiny information about the aim and structure of the standard. It also shows ...
标准号:ISO 14971:2019 EN 标准名称:医疗器械——对医疗器械实施风险管理 英文名称:Medical devices - Application of risk management to medical devices 标准状态:现行 发布日期:2019-12-10 文档简介 一、风险管理原则的指导 该标准明确了风险管理在医疗器械设计和开发过程中的重要性,并为制造商提供了在各个阶段实...
Risk management review 风险管理评审 Production and post-production activities生产和生产后活动 - 预期用途和合理可预见的滥用 Intended use and reasonably foreseeable misuse - 识别与安全相关的特性 Identification of characteristics related to safety - 识别危险和危险情况 Identification of hazards and hazardous si...
ISO 14971:2019 Risk Management for Medical Devices Listen back to our free on-demand webinar Dr Peter Bowness, Medicinal and Biologics Technical Team Manager, provides a summary of the updated ISO 14971 and the key changes from the previous version of the standard. Watch on-demand webinar Get ...
ISO 14971IEC 60601-1ISO 14971:2019normative referenceharmonized standardsdoi:10.1016/B978-0-12-813098-8.00005-2B. ElahiThe Institute of Risk Management. (2002). A Risk Management Standard. AIRMIC Publication, https://www.theirm.org/knowledge-and- resources/risk-management-standards/irms-risk-...
英文名称:Medical devices - Application of risk management to medical devices 标准状态:现行 发布日期:2019-12-10 文档简介 ISO14971:2019《医疗器械风险管理对医疗器械的应用》是一套用于医疗器械开发、生产和使用过程中的风险管理指南。它为医疗器械制造商提供了框架,以识别、评估、控制和监测与医疗器械相关的潜在...
ISO 14971 is formally recognized as the de facto risk management standard by regulatory authorities in the US, Europe, Canada, Australia, and more. ISO 14971 improves your organization's ability to reduce uncertainty, and your ability to achieve the critical objective of ensuring device safety and...