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ISO TR 80002-2:2017 ED1

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

Jun 13, 2017

General information

60.60     Jun 16, 2017

IEC

TC 62/SC 62A

Technical Report

11.040.01     35.240.80  

English  

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Scope

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.

Life cycle

NOW

PUBLISHED
ISO TR 80002-2:2017 ED1
60.60 Standard published
Jun 16, 2017