ISO 80002:2017
ISO 80002:2017 Medical device software – Part 2: Validation of software for medical device quality systems
CDN $422.00
Description
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.
Edition
1
Published Date
2017-06-13
Status
PUBLISHED
Pages
84
Language
English
Format
Secure PDF
Secure – PDF details
- Save your file locally or view it via a web viewer
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- Device limits - 3
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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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