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Часть 1. Коды типов  ISO/TS 19218 WHO Informal Consultation on Nomenclatures for Medical Devices March 23 -24, 2011 Leighton Hansel Convener ISO/TC 210 WG 3 Symbols  ISO/TS 19218-1:2011 specifies requirements for a hierarchical coding structure for describing adverse events relating to medical devices. The codes are  2005 年 11 月に ISO/TS 19218：2005 として発. 行されたが，その後第 2 版 として ISO 19218-. 1：2011（イベントコード）及び ISO 19218-2：.

Search in Google Scholar. [10] ISO/TS 19218-1:2011 – Medical devices – Hierarchical coding structure for adverse  (validation of symbols for medical devices) and ISO/TS 19218 (coding étiquettes des dispositifs médicaux) et ISO/TS 19218 (Structure de codage pour la  ISO TS 19218:2005 Background of AAMI adoption of ISO/TS 11139:2006 Upon review of ISO/TS 11139, the AAMI Sterilization Standards Committee and  Part 1 Event type codes ISO /TS 19218-2 Medical device- Hierarchical coding structure for adverse event .

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25] that [24] ISO/TS 19218-1:2011, “Medical devices—Hierarchical coding structure  16 Oct 2015 Correspondencia con la norma ISO/TS 19218:2005. Medical devices -- Hierarchical coding structure for adverse events --. Part 1: Event-type  ABNT NBR IEC 62366:2010; ABNT NBR ISO 14971:2009; ABNT ISO/TS 19218:2009 Versão Corrigida:2009; ABNT NBR ISO 31000:2009; ABNT NBR 12809:  14 Nov 2014 incidents. Clarification on trend reporting. • Move towards event coding and patient outcome coding for vigilance reports (e.g.

2012（ コーズ  ISO/TS 19218-1:2011 Part 1: Event-type codes; ISO/TS 19218-2:2012 Part 2: Evaluation codes. ISO/TR 19231:2014 Health informatics – Survey of mHealth  ISO 19011:2011. Guidelines for auditing management systems. ISO/TS 19218-1: 2011. Medical devices -- Hierarchical coding structure for adverse events -- Part  sviluppata dall'FDA per la segnalazione di eventi avversi e armonizzata con la norma tecnica ISO/TS. 19218-1 «Medical devices -- Hierarchical coding structure   26 Set 2014 Esta Parte da ABNT ISO/TS 19218 especifica requisitos para uma estrutura hierárquica de codificação para descrever eventos adversos  1 Nov 2020 ISO Update, Supplement to ISO Focus -- November 2020. 1.
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1 Medical devices - Hierarchical coding structure for adverse events - Part 1:. 22 Dec 2015 Evaluation of the adverse event (incident) (code and term of level 2 - ISO/TS 19218-2). Corrective safety actions at the local level <3>. of this, 31% of CEN standards are identical to ISO standards and 72% of Guidance on the application of ISO 17665-1 (ISO/TS 17665- ISO/TS 19218-. NC ISO 19011. 2004 Directrices para la auditoría de los sistemas de gestión de la calidad y/o ambiental.
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NC ISO 19011. 2004 Directrices para la auditoría de los sistemas de gestión de la calidad y/o ambiental. ISO/TS 19218. 2005 Medical devices. Coding structure   21 Jun 2010 PROCESO DE GESTION DE RIESGOS

• La norma ISO 14971 especifica el proceso de gestión

• ISO/TS 19218:2005. 15 Feb 2021 ISO/TS 19218-1, ISO/TC210, 2011, A1:2013, Medical devices – Hierarchical coding structure for adverse events – Part 1: Event-type codes. NOTA: Para más detalles sobre acontecimientos, véase ISO TS 19218 so- bre tipos de acontecimientos adversos y codificaciones causa/efecto.

  1：2011（イベントコード）及び ISO 19218-2：. 2012（ コーズ  ISO/TS 19218-1:2011 Part 1: Event-type codes; ISO/TS 19218-2:2012 Part 2: Evaluation codes. ISO/TR 19231:2014 Health informatics – Survey of mHealth  ISO 19011:2011. Guidelines for auditing management systems.
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  ISO/TS 19218:2005, Medical devices - Coding structure for adverse event type and cause This part of ISO/TS 19218 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, 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/TS 19218-2, together with ISO/TS 19218-1, cancels and replaces ISO/TS 19218:2005, which has been technically revised. ISO/TS 19218-1 was prepared by Technical Committee ISO/TC 210, Quality management and corresponding general aspects for medical devices.