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.
ISO/TS 19218 uses a 2-level hierarchical coding structure for reporting adverse events. Though the pilot study allowed for new proposals at these levels (level 1, 2), it was particularly designed for new proposals at an additional more granular third level. In line with this is the observation that the majority of new terms proposed
Hierarchical coding structure for adverse events DS/ISO/TS 19218:2005 ( Withdrawn ) Medical devices - Coding structure for adverse event type and cause Add to cart ISO TS 19218, 1st Edition, November 1, 2005 - Medical devices Coding structure for adverse event type and cause There is no abstract currently available for this document 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. 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. DD ISO/TS 19218-1:2011+A1:2013 Medical devices.
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Request to add this standard to your ISO/TS 19218-1:2011/Amd 1:2013. Withdrawn Date published: 07/11/20 iso ts 19218-2 : 2012(r2019) medical devices - hierarchical coding structure for adverse events - part 2: evaluation codes: iso 15225 : 2016 : medical devices - quality management - medical device nomenclature data structure Issuu is a digital publishing platform that makes it simple to publish magazines, catalogs, newspapers, books, and more online. Easily share your publications and get them in front of Issuu’s 26 Jul 2019 Proposals for new terms by manufacturers ISO/TS 19218 uses a 2-level hierarchical coding structure for reporting adverse events. Though the ISO/TS 19218. WHO Informal Consultation on Nomenclatures for Medical Devices. March 23-24, 2011. Leighton Hansel.
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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.
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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.
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This is a Draft for Development, it is not a British Standard.
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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.
159.