Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
NORMA vydaná dňa 15.8.2016
Označenie normy: ISO 15674:2016-ed.3.0
Dátum vydania normy: 15.8.2016
Počet strán: 11
Približná hmotnosť: 33 g (0.07 libier)
Krajina: Medzinárodná technická norma
Kategória: Technické normy ISO
Description / Abstract: ISO 15674:2016 specifies requirements for sterile, single-use, extracorporeal hard-shell cardiotomy/venous reservoir systems and soft venous reservoir bags intended for use as a blood reservoir during cardiopulmonary bypass (CPB) surgery. It applies only to the blood reservoir aspects for multifunctional systems which can have integral parts such as blood-gas exchangers (oxygenators), blood filters, defoamers, blood pumps, etc.