標準號：ISO/TS 25238-2007
中文標準名稱：健康信息學.健康軟件防范風險分類
英文標準名稱：Health informatics - Classification of safety risks from health software
標準類型：C07
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 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 Technical Specification is concerned with the safety of patients and gives guidance on the analysis andcategorization of hazards and risks to patients from health software products, in order to allow any product tobe assigned to one of five risk classes. It applies to hazards and risks which could cause harm to a patient.Other risks, such as financial or organizational risks, are outside the scope of this Technical Specificationunless they have the potential to harm a patient.This Technical Specification applies to any health software product, whether or not it is placed on the marketand whether it is for sale or free of charge. Examples of the application of the classification scheme are given.This Technical Specification does not apply to any software which is necessary for the proper application orfunctioning of a medical device.NOTE This Technical Specification is intended for the assignment of health software to broad risk classes, so as toaid decisions such as what controls should be applied to ensure safety. It is not intended for the application of risk analysisand risk management to the design of health software products and the mitigation of any identified risks to acceptablelevels (see Annex A).