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ISO/TS 19218:2005

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

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withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Medical devices Coding structure for adverse event type and cause
Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Withdrawn date

03-15-2019

Language(s)

English, French, Russian

Published date

11-03-2005

Publisher

International Organization for Standardization

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Withdrawn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

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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Hardcopy - English
PDF - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
Hardcopy - French
PDF - French
PDF 3 Users - French
PDF 5 Users - French
PDF 9 Users - French
Hardcopy - Russian
PDF - Russian
PDF 3 Users - Russian
PDF 5 Users - Russian
PDF 9 Users - Russian
Hardcopy - English
PDF - English
PDF 3 Users - English
PDF 5 Users - English
PDF 9 Users - English
Hardcopy - French
PDF - French
PDF 3 Users - French
PDF 5 Users - French
PDF 9 Users - French
Hardcopy - Russian
PDF - Russian
PDF 3 Users - Russian
PDF 5 Users - Russian
PDF 9 Users - Russian
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