ISO/TS 19218:2005
Withdrawn
View Superseded by
Medical devices — Coding structure for adverse event type and cause
Hardcopy , PDF
English, French, Russian
11-03-2005
03-15-2019
Foreword
Introduction
1 Scope
2 Terms and definitions
3 Code system and requirements
3.1 Adverse event type code
3.2 Adverse event cause code
Annex A (informative) Coding system for describing adverse events
Annex B (informative) Examples of coding
Bibliography
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.
| Committee |
ISO/TC 210
|
| DocumentType |
Technical Specification
|
| Pages |
11
|
| PublisherName |
International Organization for Standardization
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| GOST R ISO/TS 19218 : 2008 | Identical |
| NEN NPR ISO/TS 19218 : 2005 | Identical |
| DD ISO/TS 19218:2005 | Identical |
| AAMI ISO TIR 19218 : 2005 | Identical |
| XP ISO/TS 19218 : 2006 XP | Identical |
| ISO/TR 27809:2007 | Health informatics — Measures for ensuring patient safety of health software |
| CEN/TR 15640:2007 | Health informatics - Measures for ensuring the patient safety of health software |
| PD ISO/TR 27809:2007 | Health informatics. Measures for ensuring patient safety of health software |
| PD CEN/TR 15640:2007 | Health informatics. Measures for ensuring the patient safety of health software |
| 14/30302761 DC : 0 | BS ISO 11249 - MECHANICAL CONTRACEPTIVES - GUIDANCE FOR CLINICAL EVALUATION OF INTRA-UTERINE CONTRACEPTIVE DEVICES (IUDS) |
| MEDDEV 2.12-1 : REV 8 : 2013 | GUIDELINES ON A MEDICAL DEVICES VIGILANCE SYSTEM |
| S.R. CEN TR 15640:2007 | HEALTH INFORMATICS - MEASURES FOR ENSURING THE PATIENT SAFETY OF HEALTH SOFTWARE |
| IEC 60601-1-6:2010+AMD1:2013 CSV | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability |
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