NEN-ISO 15674
Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
| Organization: | NEN |
| Publication Date: | 1 December 2001 |
| Status: | inactive |
| Page Count: | 18 |
| ICS Code (Implants for surgery, prosthetics and orthotics): | 11.040.40 |
scope:
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. Applies only to the blood reservoir aspects for multifunctional systems which may have integral components such as blood gas exchangers (oxygenators), blood filters, defoamers, blood pumps, etc.
Document History