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ISO/TR 80002-2:2017

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

standard by International Organization for Standardization (Technical Report) , 06/01/2017

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Full Description

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.

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.
 

Product Details

Edition:
1st
Published:
06/01/2017
Number of Pages:
92
File Size:
1 file , 1.8 MB
Same As:
BS PD ISO/TR 80002-2:2017
Note:
This product is unavailable in Ukraine, Russia, Belarus