ISO TR 80002-2:2017 ED1

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

Datum objavljivanja: 13. 6. 2017.

Опште информације

Trenutna faza: 60.60 Effective date: 16. 6. 2017.

Inicijator: IEC

Pripada: TC 62/SC 62A

Vrsta: Tehnički izveštaj

ICS: 11.040.01 35.240.80

Jezik: engleski

Kupovina

Status: Objavljen

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Apstrakt

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.

Životni ciklus

TRENUTNO

OBJAVLJEN
ISO TR 80002-2:2017 ED1
60.60 Standard objavljen
16. 6. 2017.