标准编号：ISO/TR 27809:2007
中文名称：保健信息学 保健软件确保病人安全的措施
英文名称：Health informatics — Measures for ensuring patient safety of health software
发布日期：2007-07
标准范围
This Technical Report considers the control measures required to ensure patient safety in respect to healthsoftware products. It does not apply to software which is:necessary for the proper application of a medical device oran accessory to a medical device ora medical device in its own right.This Technical Report 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 voluntarymanner whether national, regional or local. However, it is not the purpose of this Technical Report torecommend whether or not health software products should be regulated.This Technical Report applies to any health software product whether or not it is placed on the market andwhether or not 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 Technical Report acknowledges that, on the boundary, there arehealth software products which are encompassed by medical device regulations in some countries but not in others andthat some definitions of medical devices may appear to cover health software products in general but in practice do not.
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