Access the most up to date content in iso standards, graphical symbols, codes or terms and definitions. Pdf iso 14971medical device risk management standard. Knowing what documents and records are necessary for iso 485. In accordance with adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. We create a unique view into management systems leveraging our experience and innovation across industries. This white paper is designed to clear up any misunderstandings regarding documents required by this standard, as well as outlining nonmandatory documents that are commonly used.
Many translated example sentences containing en iso 14971 englishspanish dictionary and search engine for english translations. The iso technical committee responsible for the maintenance of this standard is iso tc 210 working with iecsc62a through joint working group one jwg1. Checklist of mandatory documentation required by iso 485. Analisi e gestione dei rischi per i dispositivi medici. Medical devices application of risk management to medical. In accordance with adobes licensing policy, this file may be printed or viewed but shall not be edited unless the typefaces which are embedded are licensed to and installed on. This standard is the culmination of the work starting in isoiec guide 51, and isoiec guide 63. Iso 14971 is an iso standard for the application of risk management to medical devices.