1 Scope
This Technical Report considers the control measures required to ensure patientsafety in respect to health software products. It does not apply to software which is:
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— necessary for the proper application of a medical device or
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— an accessory to a medical device or
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— a medical device in its own right.
This Technical Report 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 Technical Report to recommend whether or not health software products should be regulated.
This Technical Report 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.
NOTE The 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 Technical Report 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.