標準號：BS PD CEN/TR 15640-2007
中文標準名稱：醫療信息學.確保病人安全的醫療軟件的測量
英文標準名稱：Health informatics — Measures for ensuring the patient safety of health software
標準類型：C07
發布日期：2007/9/28 12:00:00
實施日期：2007/9/28 12:00:00
中國標準分類號：C07
國際標準分類號：35.240.80
適用范圍：This document considers the control measures required to ensure patient safety in respect to health softwareproducts. It does not apply to software which is:? necessary for the proper application of a medical device or? which is an accessory to a medical device or? which is a medical device in its own right.The document is aimed at identifying what standards might best be used or created, and their nature, if healthsoftware products were to be regulated or controlled in some other formal or informal or voluntary mannerwhether national, regional or local. However it is not the purpose of this document to recommend whether ornot 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 ornot 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 deviceregulations. Annex A considers this matter in detail. This TR acknowledges that, on the boundary, there are healthsoftware products which are encompassed by medical device regulations in some countries but not in others and thatsome definitions of medical devices may appear to cover health software products in general but in practice do not.