S.R. CEN TR 15640:2007
Withdrawn
HEALTH INFORMATICS - MEASURES FOR ENSURING THE PATIENT SAFETY OF HEALTH SOFTWARE
Hardcopy , PDF
English
01-01-2007
12-08-2017
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Withdrawn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 |
| PD CEN/TR 15640:2007 | Equivalent |
| 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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