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ISO 14971 Medical devices — Application of risk management to medical devices is a voluntary consensus standard, [1] published by International Organization for Standardization (ISO) for the first time in 1998, and specifies terminology, principles, and a process for risk management of medical devices.
ISO 14971:2007 Medical devices – Application of risk management to medical devices ISO 14972:1998 Sterile obturators for single use with over-needle peripheral intravascular catheters ISO 14975:2000 Surface chemical analysis – Information formats
IEC/TR 80002-1:2009 Part 1: Guidance on the application of ISO 14971 to medical device software; ISO/TR 80002-2:2017 Part 2: Validation of software for medical device quality systems; IEC/TR 80002-3:2014 Part 3: Process reference model of medical device software life cycle processes ; ISO/TS 80004 Nanotechnologies – Vocabulary
The management of risks for medical devices is described by the International Organization for Standardization (ISO) in ISO 14971:2019, Medical Devices—The application of risk management to medical devices, a product safety standard. The standard provides a process framework and associated requirements for management responsibilities, risk ...
IEC 62304 – medical device software – software life cycle processes [1] is an international standard published by the International Electrotechnical Commission (IEC). The standard specifies life cycle requirements for the development of medical software and software within medical devices.
ISO/TR 24971:2013 Medical devices – Guidance on the application of ISO 14971; ISO 24978:2009 Intelligent transport systems – ITS Safety and emergency messages using any available wireless media – Data registry procedures
The ISO 14000 family includes most notably the ISO 14001 standard, which represents the core set of standards used by organizations for designing and implementing an effective environmental management system (EMS). Other standards in this series include ISO 14004, which gives additional guidelines for a good EMS, and more specialized standards ...
These obligations are comparable with the MDD Annex I Essential Requirements but are expanded and include the requirement to establish, implement, document and maintain a risk management system, the requirements of which are in alignment with ISO 14971, the ISO standard for the application of risk management to medical devices.
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