Standard

ISO TR 80002-2:2017 ED1

Jun 2017 Current

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Abstract

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.

Products specifications

Standard from IEC
Published: June 13 2017
Edition: 1
Document type: TR
Pages
ISBN:

Publisher: IEC
Distributor: IEC
ICS: 11.040.01
ICS: 35.240.80
International TC: TC 62/SC 62A

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Abstract

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