（ISO/TR 80002-2-2017），英文名为Medical device software -- Part 2: Validation of software for medical device quality systems。
它（ISO/TR 80002-2-2017）是在2017-06-01发布，在2017-06-01开始实施。
ISO/TR 80002-2:2017 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. ISO/TR 80002-2:2017 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.
本标准文件共有92页。
ISO_TR 80002-2-2017 Medical device software -- Part 2_ Validation of software for medical device quality systems.pdf
(2.45 MB)
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