ISO/TC 150/SC 6/WG 4 - Implantable infusion pumps
Pompes implantables pour infusion
General Information
Frequently Asked Questions
ISO/TC 150/SC 6/WG 4 is a Subcommittee within the International Organization for Standardization (ISO). It is named "Implantable infusion pumps". This committee has published 2 standards.
ISO/TC 150/SC 6/WG 4 develops ISO standards in the area of Information technology. Currently, there are 2 published standards from this subcommittee.
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 Subcommittee (SC) in ISO operates under a Technical Committee and focuses on a specific subset of the TC's scope. Subcommittees develop standards and technical specifications in their specialized area, reporting to their parent Technical Committee. They may also have working groups for detailed technical work.
This document specifies particular requirements for active implantable medical devices intended to deliver a medicinal substance to site-specific locations within the human body, to provide basic assurance of safety for both patients and users. It amends and supplements ISO 14708-1:2014. The requirements of this document take priority over those of ISO 14708-1. This document is applicable to active implantable medical devices intended to deliver medicinal substances to site-specific locations within the human body. This document is also applicable to some non-implantable parts and accessories of the devices defined in Clause 3. The tests that are specified in this document are type tests intended to be carried out on a sample of a device to show compliance and are not intended to be used for the routine testing of manufactured products. NOTE This document is not intended to apply to non-implantable infusion systems.
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ISO 14708-4:2008 is applicable to active implantable medical devices intended to deliver medicinal substances to site-specific locations within the human body. ISO 14708-4:2008 is also applicable to some non-implantable parts and accessories of the devices. The tests that are specified in ISO 14708-4:2008 are type tests intended to be carried out on a sample of a device to show compliance, and are not intended to be used for the routine testing of manufactured products.
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