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ISO - 14708-4

Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pump systems

active, Most Current
Organization: ISO
Publication Date: 1 February 2022
Status: active
Page Count: 68
ICS Code (Implants for surgery, prosthetics and orthotics): 11.040.40
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.

Document History

14708-4
February 1, 2022
Implants for surgery — Active implantable medical devices — Part 4: Implantable infusion pump systems
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...
ISO 14708-4
November 15, 2008
Implants for surgery - Active implantable medical devices - Part 4: Implantable infusion pumps
This part of ISO 14708 is applicable to active implantable medical devices intended to deliver medicinal substances to site-specific locations within the human body. This part of ISO 14708 is also...

References

This document references:
ASTM F2503 - Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment
Published by ASTM on February 1, 2020
This international standard applies to the practice of marking of items that might be used in the magnetic resonance (MR) environment. The purpose of this practice is to mark items that might be...
This document references:
IEC 60601-1 - MEDICAL ELECTRICAL EQUIPMENT – Part 1: General requirements for basic safety and essential performance
Published by IEC on March 1, 2021
A description is not available for this item.
This document references:
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
Published by IEC on September 1, 2020
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS....
This document references:
IEC 61000-4-3 - Electromagnetic compatibility (EMC) – Part 4-3: Testing and measurement techniques – Radiated, radio-frequency electromagnetic field immunity test
Published by IEC on September 1, 2020
This part of IEC 61000 is applicable to the immunity requirements of electrical and electronic equipment to radiated electromagnetic energy. It establishes test levels and the required test...
This document references:
IEC 61000-4-39 - Electromagnetic compatibility (EMC) – Part 4-39: Testing and measurement techniques – Radiated fields in close proximity – Immunity test
Published by IEC on March 1, 2017
This part of IEC 61000 specifies immunity requirements for electrical and electronic equipment when it is exposed to radiated electromagnetic energy from RF transmitters used in close proximity. It...
This document is referenced by:
BS EN 50527-1 - TC - Tracked Changes (Redline) - Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices Part 1: General
Published by BSI on February 25, 2020
A description is not available for this item.
This document is referenced by:
BS EN 50527-1 - Procedure for the assessment of the exposure to electromagnetic fields of workers bearing active implantable medical devices Part 1: General
Published by BSI on January 31, 2017
A description is not available for this item.
This document is referenced by:
AAMI ES60601-1 - Medical electrical equipment-Part 1: General requirements for basic safety and essential performance
Published by AAMI on January 1, 2005
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as ME EQUIPMENT and ME SYSTEMS....
This document is referenced by:
F3566 - Standard Performance Specifications and Test Methods for Walk-Through Metal Detectors Used in Safety and Security
November 1, 2022
This standard applies to all walk-through metal detectors that are used to find metal contraband concealed or hidden on people. This standard describes baseline acceptable technical performance...
This document is referenced by:
CSA C22.2 NO 60601-1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
Published by CSA on January 1, 2014
This Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS designed to be used in accordance with CSA C22.1 (Canadian...
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