ISO TR 80002-2:2017 

Medical device software - Part 2: Validation of software for medical device quality systems


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ISO/TR 80002-2:2017(E) 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.

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Additional information

Publication typeTechnical Report
Publication date2017-06-13
Available language(s)English
TC/SCTC 62/SC 62A - Common aspects of electrical equipment used in medical practicerss
ICS11.040.01 - Medical equipment in general
35.240.80 - IT applications in health care technology
Stability date  2027
File size1877 KB

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