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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 15784-1:2008 Part 1: General principles and documentation framework of application profiles; ISO 15784-2:2015 Part 2: Centre to field device communications using SNMP; ISO 15784-3:2008 Part 3: Application profile-data exchange (AP-DATEX) ISO 15785:2002 Technical drawings – Symbolic presentation and indication of adhesive, fold and pressed ...
Printable version; In other projects Wikimedia Commons; Wikidata item; Appearance. move to sidebar hide ... ISO 1 – ISO 1999; ISO 2000 – ISO 2999; ISO 3000 ...
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 ...
ISO 13485 Medical devices -- Quality management systems -- Requirements for regulatory purposes is a voluntary standard, [1] published by International Organization for Standardization (ISO) for the first time in 1996, and contains a comprehensive quality management system for the design and manufacture of medical devices.
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.