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ISO/TR 80002-2:2017

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

Standard Details

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

Status : Published
Standard Type: Main
Document No: ISO/TR 80002-2:2017
Document Year: 2017
Pages: 84
Edition: 1
  • Section Volume:
  • ISO/TC 210. Quality management and corresponding general aspects for medical devices
  • ICS:
  • 11.040.01 Medical equipment in general
  • 35.240.80 IT applications in health care technology

Life Cycle

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ISO/TR 80002-2:2017
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