ISO-80002-2 › Medical device software - Part 2: Validation of software for medical device quality systems

ISO-80002-2 - 1ST EDITION - CURRENT


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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.

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11.040.01 (Medical equipment in general)

35.240.80 (IT applications in health care technology Including computer tomography)

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Document Number

ISO/TR 80002-2:2017

Revision Level

1ST EDITION

Status

Current

Publication Date

June 1, 2017

Committee Number

ISO/TC 210