ISO/TS 19218-1 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices. This first edition of ISO/TS 19218-1 , together with ISO/TS 19218-2 , cancels and replaces ISO/TS 19218:2005 , which has been technically revised.

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ISO/TS 19218-1:2011 specifies requirements for a hierarchical coding structure for describing adverse events relating to medical devices. The codes are intended for use by medical device users, manufacturers, regulatory authorities, health care facilities and other organizations. Abstract ISO/TS 19218-2:2012 specifies requirements for a hierarchical coding structure for characterizing the results of the analysis or evaluation of adverse events relating to medical devices. The codes are intended primarily for use by medical device manufacturers and regulatory authorities. ISO/TS 19218:2005 specifies requirements for a coding structure for describing adverse events related to medical devices. This code is intended for use by medical device users, manufacturers and regulatory authorities.

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The codes are intended for use by medical device users, manufacturers, regulatory authorities, health care facilities and other organizations. ISO/TS 19218-2:2012 specifies requirements for a hierarchical coding structure for characterizing the results of the analysis or evaluation of adverse events relating to medical devices. The codes are intended primarily for use by medical device manufacturers and regulatory authorities. ISO/TS 19218-2:2012 specifies requirements for a hierarchical coding structure for characterizing the results of the analysis or evaluation of adverse events relating to medical devices.

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ISO/TS 19218:2005 specifies requirements for a coding structure for describing adverse events related to medical devices. This code is intended for use by medical device users, manufacturers and regulatory authorities.

The codes are intended primarily for use by medical device manufacturers and regulatory authorities. ISO/TS 19218:2005 specifies requirements for a coding structure for describing adverse events related to medical devices. This code is intended for use by medical device users, manufacturers and regulatory authorities. ISO/TS 19218-1:2011/Amd 1:2013 Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes — Amendment 1 It is envisaged that the adverse-event evaluation codes specified in this part of ISO 19218 will originate primarily from the manufacturer of the device concerned.

DD ISO/TS 19218-1:2011+A1:2013 Medical devices. Hierarchical coding structure for adverse events. Event-type codes BS EN ISO 11073-20601:2016 - TC Tracked Changes. Health informatics. Personal health device communication. Application profile.

B) Se sospecha  CAUSA PROBABLE. Un total de 47 tipos de causas. Correspondencia con la norma ISO/TS 19218:2005. Medical devices -- Hierarchical coding structure for. De hecho, la norma ISO 14971 está elaborada de forma que se pueda incorporar fácilmente en un sistema de gestión de la calidad que ISO/TS 19218:2005. 第1部分:用于医疗设备软件的ISO 14971 应用指南, Medical device software - Part 1: Guidance on the application of ISO 14971 to ISO/TS 19218-2005, 医疗设备. Структура кодов видов и причин неблагоприятных событий" (ISO/TS 19218: 2005 "Medical devices - Coding structure for adverse event type and cause").

Iso ts 19218

Medical devices -- Coding structure for adverse event type and cause. Status: Upphävd Medical devices -- Hierarchical coding structure for adverse events -- Part 2: Evaluation codes - ISO/TS 19218-2:2012 ISO/TS 19218-2 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices . This first edition of ISO/TS19218-2, together with ISO/TS 19218-1, cancels and replaces ISO/TS 19218:2005, ISO/TS 19218:2005(E) PDF disclaimer This PDF file may contain embedded typefaces.
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Iso ts 19218

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March 23-24, 2011. Leighton Hansel. Convener ISO/TC210 WG3. Symbols  ABNT ISO/TS 19218: Esta Especificação Técnica especifica requisitos para uma estrutura de código para descrever eventos adversos relacionados a produtos. 9 Mar 2015 ABNT ISO/TS 19218-1:2014 Emenda 1:2015.
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sviluppata dall'FDA per la segnalazione di eventi avversi e armonizzata con la norma tecnica ISO/TS. 19218-1 «Medical devices -- Hierarchical coding structure  

The codes are intended primarily for use by medical device manufacturers and regulatory authorities. ISO/TS 19218-2:2012 specifies requirements for a hierarchical coding structure for characterizing the results of the analysis or evaluation of adverse events relating to medical devices. The codes are intended primarily for use by medical device manufacturers and regulatory authorities. ISO/TS 19218-1:2011 - Amendment General information Withdrawn from 02.10.2020 ICS Groups. 03.120.10 Quality Standard ISO/TS 19218-1:2011 5.5.2011 - Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes (Dispositifs ISO/TS 19218:2005 Medical devices - Coding structure for adverse event type and cause.