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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(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.

General Information

Status : ACTIVE
Standard Type: Main
Document No: ISO TR 80002-2:2017
Document Year: 2017
Pages: 84
Edition: 1.0
  • Section Volume:
  • TC 62.SC 62A Common aspects of electrical equipment used in medical practice
  • ICS:
  • 11.040.01 Medical equipment in general
  • 35.240.80 IT applications in health care technology

Life Cycle

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ACTIVE
ISO TR 80002-2:2017
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