ISO 80002:2017
ISO 80002:2017 Medical device software – Part 2: Validation of software for medical device quality systems
CDN $442.00
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
- Viewing permissions are restricted exclusively to the purchaser
- Device limits - 3
- Printing – Enabled only to print (1) copy
See more about our Environmental Commitment
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.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-
ISO 80001:2012 Application of risk management for IT-networks incorporating medical devices – Part 2-2: Guidance for the communication of medical device security needs, risks and controls
CDN $594.00 Add to cart -
ISO 63:2019 Guide to the development and inclusion of aspects of safety in International Standards for medical devices
CDN $263.00 Add to cart -
ISO 15378:2017 Primary packaging materials for medicinal products – Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
CDN $438.00 Add to cart -
ISO 80002:2014 Medical device software – Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
CDN $409.00 Add to cart
