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 August 2016 |
| Status: | active |
| Page Count: | 19 |
| ICS Code (Implants for surgery, prosthetics and orthotics): | 11.040.40 |
scope:
NEN-ISO 15674 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. This document 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.
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