PD CEN/TR 15640:2007

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.

Contents of PD CEN/TR 15640 includes:

• Scope
• 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
• Conclusions
• 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
• Conclusions
• Observation on safety and risks in the user domain
• Conclusions
• Taxonomies
• Conclusions
• 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
• Conclusions
• 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
• Bibliography