Kardiovaskulární implantáty a umělé orgány - Výměníky krevních plynů (oxygenátory) (Norma k přímému použití jako ČSN).

The information about the standard:

Designation standards: ČSN EN ISO 7199
Classification mark: 856250
Catalog number: 502444
Publication date standards: 1.8.2017
The number of pages: 32
Approximate weight : 96 g (0.21 lbs)
Country: Czech technical standard
Kategorie: Technické normy ČSN

Annotation of standard text ČSN EN ISO 7199 (856250):

This document 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. This document also applies to heat exchangers and arterial filters that are integral parts of the oxygenator. This document also applies to external equipment unique to the use of the oxygenator. This document does not apply to - implanted oxygenators, - liquid oxygenators, - extracorporeal circuits (blood tubing), - separate heat exchangers, - separate ancillary devices, and - separate arterial line filter