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ISO/TR 80002-2:2017 Preview
Medical device software -- Part 2: Validation of software for medical device quality systems
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.
General information
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Current status : PublishedPublication date : 2017-06
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Edition : 1Number of pages : 84
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Technical Committee:Quality management and corresponding general aspects for medical devices
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- ICS :
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Medical equipment in general
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IT applications in health care technology
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