20/30408361 DC - BS ISO 18193. Cardiovascular implants and artificial organs. Cannulae for extracorporeal circulation

20/30408361 DC

BS ISO 18193. Cardiovascular implants and artificial organs. Cannulae for extracorporeal circulation

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

Format
PDF

Format
HARDCOPY



This document specifies requirements for sterile, single-use cannulae for removal and delivery of patients’ blood during cardiopulmonary bypass (CPB) up to 6 h duration, extracorporeal lung assist (ECLA with VV, VAV, or AV cannulation strategies), left or right heart bypass (LHB, RHB), cardiopulmonary support (CPS), extracorporeal life support (ECLS with VA cannulation strategy), extracorporeal carbon dioxide removal (ECCO2R), and other extracorporeal circulation techniques. This standard will not apply to:

  • introducers (e.g., guidewires) as addressed in ISO 11070;

  • isolated organ perfusion cannulae;

  • intravascular catheters as addressed in ISO 10555-3.




Standard Number20/30408361 DC
TitleBS ISO 18193. Cardiovascular implants and artificial organs. Cannulae for extracorporeal circulation
StatusCurrent, Draft for public comment
Publication Date18 March 2020
Normative References(Required to achieve compliance to this standard)ISO 17665-1, ISO 11607-1, ISO 14937, ISO 10993-7, ASTM F640-12, ISO 11607-2, ISO 10993-4, ISO 10993-1, ISO 11135, ISO 11137-1, ISO 10993-11, DIN 13273-7
Informative References(Provided for Information)ISO 13485, ISO 14971, ISO 10555-1, ISO/TS 23810, ISO 11070, ISO 10555-3, ISO 8637-1:2017
International RelationshipsISO/DIS 18193
Draft Expiry Date11 May 2020
DescriptorsImplants (surgical), Surgical implants, Cardiovascular system, Artificial organs, Tests
ICS11.040.40
Title in FrenchTitre manque
CommitteeCH/150/2
PublisherBSI
FormatA4
DeliveryYes
Pages41
File Size2.838 MB
NotesWarning: this draft is not current beyond its expiry date for comments.
Price£20.00


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