S.R. CEN TR 15640:2007
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
HEALTH INFORMATICS - MEASURES FOR ENSURING THE PATIENT SAFETY OF HEALTH SOFTWARE
Hardcopy , PDF
08-12-2017
English
01-01-2007
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Foreword
Introduction
1 Scope
2 Terms and definitions
3 Symbols and abbreviations
4 Outline of the issues
5 General position on medical device controls
6 The border between health software products and
medical devices
7 Classifying health software products
8 Options for control measures for health software
products
9 Standards specific to risks of a particular nature
10 Observation on safety and risks in the user domain
11 Taxonomies
12 Summary of conclusions
Annex A (informative) - Position regarding medical
devices in different countries
Annex B (informative) - Analysis of classification
procedures
Annex C (informative) - Risk management
Bibliography
Provides control measures required to ensure patient safety in respect to health software products.
| DevelopmentNote |
Issue date: 21/05/2011. (06/2011)
|
| DocumentType |
Standard
|
| Pages |
46
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Withdrawn
|
| Standards | Relationship |
| CEN/TR 15640:2007 | Identical |
| ISO/IEC 27001:2013 | Information technology — Security techniques — Information security management systems — Requirements |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| IEC 61508-5:2010 | Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 5: Examples of methods for the determination of safety integrity levels (see Functional Safety and IEC 61508) |
| CFR 21(PTS800-1299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
| ISO/TR 14969:2004 | Medical devices Quality management systems Guidance on the application of ISO 13485: 2003 |
| IEC 61508-3:2010 | Functional safety of electrical/electronic/programmable electronic safety-related systems - Part 3: Software requirements (see Functional Safety and IEC 61508) |
| PD 6668:2000 | Managing risk for corporate governance |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO/IEC Guide 51:2014 | Safety aspects — Guidelines for their inclusion in standards |
| ISO/TS 19218:2005 | Medical devices Coding structure for adverse event type and cause |
| IEC 62304:2006+AMD1:2015 CSV | Medical device software - Software life cycle processes |
| AS/NZS 4360:2004 | Risk management |
| ISO/IEC 12207:2008 | Systems and software engineering — Software life cycle processes |
| ISO 9001:2015 | Quality management systems — Requirements |
| ISO/IEC TR 15271:1998 | Information technology Guide for ISO/IEC 12207 (Software Life Cycle Processes) |
| CEN/TS 15260:2006 | Health informatics - Classification of safety risks from health informatics products |
| ISO/IEC 90003:2014 | Software engineering Guidelines for the application of ISO 9001:2008 to computer software |
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