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CEN/TR 15640:2007

Withdrawn
Withdrawn

A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

Health informatics - Measures for ensuring the patient safety of health software
Withdrawn date

11-16-2017

Published date

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 orwhich is an accessory to a medical device orwhich 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

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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