PD CEN/TR 15640:2007

PD CEN/TR 15640:2007

Health informatics. Measures for ensuring the patient safety of health software

Status : Current   Published : September 2007



PD CEN/TR 15640 considers the control measures required to ensure patient safety in respect to health software products.

PD CEN/TR 15640 is a document that aims to identify 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.

The scope is intended to cover health software products which are not, in practice, covered by medical device regulations, and PD CEN/TR 15640 considers this matter in detail. PD CEN/TR 15640 acknowledges that, on the boundary, there are health software products that 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.

PD CEN/TR 15640 does not apply to software that is:

    • Necessary for the proper application of a medical device
    • That is an accessory to a medical device
    • That is a medical device in its own right.

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Introduction to PD CEN/TR 15640:2007

Contents of PD CEN/TR 15640 includes:

Terms and definitions
Symbols and abbreviations
Outline of the issues
General position on medical device controls
The border between health software products and medical devices
Classifying health software products
Options for control measures for health software products
Labelling and documentation
Clinical evidence
Incident reporting
Quality Systems
Design control
Risk management
Standards specific to risks of a particular nature
Observation on safety and risks in the user domain
Summary of conclusions
Position regarding medical devices in different countries
The EU, Australia, Canada and USA
Attributes necessary for successful uptake of risk management processes
The Global Harmonization Task Force (GHTF)
Analysis of classification procedures
EU, Australian, Canadian and GHTF Medical Device Classification
USA Medical Device Classification
USA FDA guidance related to software classification
CEN classification of health software products
Risk management
Minimum components for an effective risk management process
'Enterprise risk management' processes
'Healthcare related' risk management standards
Related risk management standards
Overall conclusions regarding risk management standards

Standard NumberPD CEN/TR 15640:2007
TitleHealth informatics. Measures for ensuring the patient safety of health software
Publication Date28 September 2007
Normative References(Required to achieve compliance to this standard)No other standards are normatively referenced
Informative References(Provided for Information)ISO/TMB:2005, 98/79/EC, 93/42/EEC, ISO/IEC 90003:2004, EN ISO 14155, ISO 13485:2003, PD 6668:2000, IEC 62304:2004, ISO/FDIS 14971:2005, ISO/IEC Guide 51:1999, ISO/TR 14969:2004, 90/385/EEC, ISO/TS 19218:2005, AS/NZS 4360:2004, ISO/IEC 12207:1995, ISO 9001:2000, ISO/IEC TR 15271:1998, IEC 61508-3:1998, ISO 9001:1994, ISO/IEC 12207:1995/AMD 1:2002, ISO/IEC 27001:2005, CEN/TS 15260:2006, IEC 61508-5:1998, EN 1041:1998
International RelationshipsCEN/TR 15640:2007
DescriptorsMedical sciences, Data storage protection, Data security, Data processing, Health services, Hazards, Management, Patients, Risk assessment, Safety measures, Standards, Quality, Computer software, Information exchange
Title in FrenchInformatique de santé. Mesures pour assurer la sécurité du patient vis à vis des logiciels de santé
Title in GermanInformatik im Gesundheitswesen. Sicherstellung der Patientensicherheit bei der Nutzung von Gesundheitsinformatikprodukten
ISBN978 0 580 56879 4
File Size460 KB

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