20/30394028 DC - BS EN ISO 14708-4. Implants for surgery. Active implantable medical devices. Part 4. Implantable infusion pump systems

20/30394028 DC

BS EN ISO 14708-4. Implants for surgery. Active implantable medical devices. Part 4. Implantable infusion pump systems

Status : Current, Draft for public comment   Published : April 2020

Format
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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 as 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.




Standard Number20/30394028 DC
TitleBS EN ISO 14708-4. Implants for surgery. Active implantable medical devices. Part 4. Implantable infusion pump systems
StatusCurrent, Draft for public comment
Publication Date09 April 2020
Normative References(Required to achieve compliance to this standard)IEC 61000-4-3:2006/ISH1:2008, ISO/TS 10974:2018, IEC 61000-4-3:2006, ISO 14708-1:2014, ISO 14971
Informative References(Provided for Information)IEC 61000-4-39:2017, ISO 11631:1998, ISO 15223-1:2016, ISO/TR 14283:2018, IEC 60601-1:2005+A1:2012, IEC 60601-1-2:2014+A1:2020
International RelationshipsISO/DIS 14708-4
Draft Expiry Date26 May 2020
DescriptorsSurgeries, Surgical equipment, Medical equipment, Surgical implants, Implants (surgical)
ICS11.040.40
Title in FrenchImplants chirurgicaux — Dispositifs médicaux implantables actifs — Partie 4: Pompes d'infusion en implant Partie 4: Systèmes de pompe à perfusion implantables
CommitteeCH/150/2
PublisherBSI
FormatA4
DeliveryYes
Pages77
File Size1.817 MB
NotesWarning: this draft is not current beyond its expiry date for comments.
Price£20.00


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