ISO/TR 27809:2007 Preview

Health informatics -- Measures for ensuring patient safety of health software

ISO/TR 27809:2007 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
  • an accessory to a medical device or
  • a medical device in its own right.

ISO/TR 27809:2007 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 ISO/TR 27809:2007 to recommend whether or not health software products should be regulated.

ISO/TR 27809:2007 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.


General information

  • Current status : Published
    Publication date : 2007-07
  • Edition : 1
    Number of pages : 38
  • :
    ISO/TC 215
    Health informatics
  • 35.240.80
    IT applications in health care technology

Buy this standard

Format Language
PDF
Paper
  • CHF158

Got a question?

Check out our FAQs


Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

You may be interested in:

Keep up to date with ISO

Sign up to our newsletter for the latest news, views and product information