IEC/IEC/TC 1 - IEC/IEC/TC 1
IEC/IEC/TC 1
General Information
Frequently Asked Questions
IEC/IEC/TC 1 is a Technical Committee within the International Organization for Standardization (ISO). It is named "IEC/IEC/TC 1". This committee has published 1 standards.
IEC/IEC/TC 1 develops ISO standards. Currently, there are 1 published standards from this technical committee.
The International Organization for Standardization (ISO) is an independent, non-governmental international organization that develops and publishes international standards. Founded in 1947 and headquartered in Geneva, Switzerland, ISO brings together experts from 170+ member countries to share knowledge and develop voluntary, consensus-based standards that support innovation and provide solutions to global challenges.
A Technical Committee (TC) in ISO is a group of experts responsible for developing international standards in a specific technical area. TCs are composed of national member body delegates and work through consensus to create standards that meet global industry needs. Each TC may have subcommittees (SCs) and working groups (WGs) for specialized topics.
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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