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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 14917:2017 Thermal spraying - Terminology, classification; ISO 14949:2001 Implants for surgery – Two-part addition-cure silicone elastomers; ISO 14963:2003 Mechanical vibration and shock – Guidelines for dynamic tests and investigations on bridges and viaducts; ISO 14971:2007 Medical devices – Application of risk management to medical ...
The European version of the risk management standard was updated in 2009 and again in 2012 to refer to the Medical Devices Directive (MDD) and Active Implantable Medical Device Directive (AIMDD) revision in 2007, as well as the In Vitro Medical Device Directive (IVDD). The requirements of EN 14971:2012 are nearly identical to ISO 14971:2007.
Download as PDF; Printable version; In other projects Wikimedia Commons; Wikidata item; Appearance. ... ISO 1 – ISO 1999; ISO 2000 – ISO 2999; ISO 3000 – ISO 4999;
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.
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The FDIC is an independent government agency charged with maintaining stability and public confidence in the U.S. financial system and providing insurance on consumer deposit accounts.
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