ISO 14708-4:2022 PDF

Scope: 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.

ISO 14708-4:2022 Referenced Document

IEC 60601-1 Medical electrical equipment - ALL PARTS
IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests*， 2024-04-22 Update
IEC 61000-4-3 Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
ISO 14708-1 Implants for surgery - Active implantable medical devices - Part 1: General requirements for safety, marking and for information to be provided by the manufacturer
ISO/TS 10974 Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical device

2022 ISO 14708-4:2022 Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pump systems
2008 ISO 14708-4:2008 Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps