BS EN ISO 7199:2014 - Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)

BS EN ISO 7199:2014

Cardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)

Status : Revised, Superseded, Withdrawn   Published : November 2009 Replaced By : BS EN ISO 7199:2016+A1:2020

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ISO 7199:2009 specifies requirements for sterile, single-use, extracorporeal blood-gas exchangers (oxygenators) intended for supply of oxygen to, and removal of carbon dioxide from, the blood of humans. ISO 7199:2009 also applies to heat exchangers that are integral parts of oxygenators and to external equipment unique to the use of the device.




Standard NumberBS EN ISO 7199:2014
TitleCardiovascular implants and artificial organs. Blood-gas exchangers (oxygenators)
StatusRevised, Superseded, Withdrawn
Publication Date30 November 2009
Withdrawn Date31 January 2017
Normative References(Required to achieve compliance to this standard)ISO 10993-7, ISO 17665-1, ISO 11135:1994, ISO 11607-1, ISO 11607-2, ISO 10993-1, ISO 10993-11, ISO 11137-1
Informative References(Provided for Information)ISO 14971, 93/42/EEC, ISO 594-2, ISO 13485, ISO 8637:1989, PD ISO/TS 23810:2018, ISO/TS 23810:2018
Replaced ByBS EN ISO 7199:2016+A1:2020
International RelationshipsEN ISO 7199:2014
Amended ByCorrigendum, December 2014; Amendment, April 2012
DescriptorsSterile equipment, Instructions for use, Medical equipment, Blood, Artificial lungs, Heat exchangers, Artificial organs, Oxygen, Circulatory system, Performance, Carbon dioxide, Performance testing
ICS11.040.40
Title in FrenchImplants cardiovasculaires et organes artificiels. Échangeurs gaz/sang extracorporels (oxygénateurs)
Title in GermanKardiovasculäre Implantate und künstliche Organe. Blut Oxygenatoren
CommitteeCH/150/2
ISBN978 0 580 84588 8
PublisherBSI
FormatA4
DeliveryNo
Pages22
File Size755 KB
Price£130.00


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