标准编号：ISO/TR 80002-2:2017
中文名称：医疗器械软件 第2部分：医疗器械质量体系验证软件
英文名称：Medical device software — Part 2: Validation of software for medical device quality systems
发布日期：2017-06
标准范围
This document applies to any software used in device design, testing, component acceptance,
manufacturing, labelling, packaging, distribution and complaint handling or to automate any other
aspect of a medical device quality system as described in ISO 13485.
This document applies to
— software used in the quality management system,
— software used in production and service provision, and
— software used for the monitoring and measurement of requirements.
It does not apply to
— software used as a component, part or accessory of a medical device, or
— software that is itself a medical device.
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