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Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.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
11-16-2017
08-08-2007
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
This document considers the control measures required to ensure patient safety in respect to health software products. It does not apply to software which is:necessary for the proper application of a medical device orwhich is an accessory to a medical device orwhich is a medical device in its own right. The document is aimed at identifying what standards might best be used or created, and their nature, if health software products were to be regulated or controlled in some other formal or informal or voluntary manner whether national, regional or local. However it is not the purpose of this document to recommend whether or not health software products should be regulated. This document applies to any health software product whether or not it is placed on the market and whether or not it is for sale or free of charge. It is addressed to manufacturers of health software products.NOTEThe scope is intended to cover health software products which are not, in practice, covered by medical device regulations. Annex A considers this matter in detail. This TR acknowledges that, on the boundary, there are health software products which are encompassed by medical device regulations in some countries but not in others and that some definitions of medical devices may appear to cover health software products in general but in practice do not.
| Committee |
CEN/TC 251
|
| DocumentType |
Technical Report
|
| PublisherName |
Comite Europeen de Normalisation
|
| Status |
Withdrawn
|
| Standards | Relationship |
| NEN NPR CEN/TR 15640 : 2007 | Identical |
| S.R. CEN TR 15640:2007 | Identical |
| PD CEN/TR 15640:2007 | Identical |
| PNE-prCEN/TR 15640 | 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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