Health informatics - Measures for ensuring the patient safety of health software
Abstract
This Technical Report will consider the control measures required to assure patient safety of health informatics products. It does not apply to software necessary for the proper application of a medical device or which is an accessory to a medical device. It considers hazards and risks which could cause harm to a patient. Other risks such as financial or organisational are out of scope unless they have the potential to harm a patient.It is not the purpose of this document to recommend whether or not health informatics products should be regulated. However it is aimed at identifying what standards might best be used or created, and their nature, if health informatics products were to be regulated or controlled in some formal or informal or voluntary manner whether national, regional or local.
Begin
2006-03-15
WI
00251210
Planned document number
prCEN/TR 15640
Project number
06301121
