Aktivní norma | Vydána: 13.06.2017

ISO/TR 80002-2:2017

Medical device software — Part 2: Validation of software for medical device quality systems
(Logiciels de dispositifs médicaux — Partie 2: Validation des logiciels pour les systemes de qualité des dispositifs médicaux)

Dostupné jazyky: Anglicky

Dostupné provedení: Elektronické PDF, Tištěné

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Podrobné informace

Označení: ISO/TR 80002-2:2017

Datum vydání: 13.06.2017

Stran: 84

Země: Mezinárodní technická norma

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Anotace

Description / Abstract: 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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