ISO/TR 27809:2007 保健信息学 保健软件确保病人安全的措施

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

ISO/TR 27809:2007考虑了确保健康软件产品患者安全所需的控制措施。它不适用于以下软件:正确应用医疗器械所必需的，或医疗器械的附件或本身就是一种医疗器械。ISO/TR 27809:2007旨在确定如果健康软件产品要以其他正式、非正式或自愿的方式（无论是国家、地区还是地方）进行监管或控制，哪些标准可以最好地使用或创建，以及它们的性质。然而，ISO/TR 27809:2007的目的不是建议健康软件产品是否应该受到监管。ISO/TR 27809:2007适用于任何健康软件产品，无论其是否投放市场，也无论其是否出售或免费。它面向健康软件产品的制造商。

ISO/TR 27809:2007 considers the control measures required to ensure patient safety in respect to health software products. It does not apply to software which is:

• necessary for the proper application of a medical device or
• an accessory to a medical device or
• a medical device in its own right.

ISO/TR 27809:2007 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 voluntary manner whether national, regional or local. However, it is not the purpose of ISO/TR 27809:2007 to recommend whether or not health software products should be regulated.ISO/TR 27809:2007 applies to any health software product whether or not it is placed on the market and whether or not it is for sale or free of charge. It is addressed to manufacturers of health software products.

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