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SRPS EN ISO 7199:2016

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

Oct 31, 2016
95.99   Withdrawal of Standard   Sep 25, 2017

General information

95.99     Sep 25, 2017

ISS

Z076

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

NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.

93/42/EEC

Medical devices

Life cycle

NOW

WITHDRAWN
SRPS EN ISO 7199:2016
95.99 Withdrawal of Standard
Sep 25, 2017

REVISED BY

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SRPS EN ISO 7199:2017

Related project

Adopted from EN ISO 7199:2014

Adopted from ISO 7199:2009/Amd 1:2012 IDENTICAL

Adopted from ISO 7199:2009 IDENTICAL