ISO/TS 19218:2005
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
Medical devices Coding structure for adverse event type and cause
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
15-03-2019
English, French, Russian
03-11-2005
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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.
| 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Withdrawn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 |
| UNI ISO/TS 19218 : 2007 | 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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