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SSH EN ISO 7199:2014

Cardiovascular implants and artificial organs - Blood-gas exchangers (oxygenators) (ISO 7199:2009 + Amd 1:2012)

Nov 27, 2015
95.99 Withdrawal of Standard   Oct 20, 2017

General information

95.99     Oct 20, 2017

DPS

DPS/KT 205

European Norm

11.040.40  

English  

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Scope

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.

Related directives

Directives related to this standards.

93/42/EEC

Medical devices

Directive 93/42/EEC

Life cycle

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SSH EN ISO 7199:2014
95.99 Withdrawal of Standard
Oct 20, 2017

REVISED BY

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SSH EN ISO 7199:2017

Related project

Adopted from EN ISO 7199:2014