BS PD CEN/TR 15640-2007 医疗信息学.确保病人安全的医疗软件的测量

标准号：BS PD CEN/TR 15640-2007
中文标准名称：医疗信息学.确保病人安全的医疗软件的测量
英文标准名称：Health informatics — Measures for ensuring the patient safety of health software
标准类型：C07
发布日期：2007/9/28 12:00:00
实施日期：2007/9/28 12:00:00
中国标准分类号：C07
国际标准分类号：35.240.80
适用范围：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.