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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 ...
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.
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/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
Page 2 of 45 Association, Hispanic Lawyers’ Association of Illinois, Illinois State Bar Association, Lesbian and Gay Bar Association of Chicago, Puerto Rican Bar Association, and the Women’s Bar Association of Illinois.
ISO 24517-1:2008 Part 1: Use of PDF 1.6 (PDF/E-1) ... Guidance on the application of ISO 14971; ISO 24978:2009 Intelligent transport systems – ITS Safety and ...
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