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In accordance with Adobe's licensing policy, this file may be printed or viewed but 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. 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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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>.

Evaluation codes BS EN ISO 11073-20601:2016 - TC Tracked Changes. Health informatics.
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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.

Tekniska data/Specifications. ISO VG80.