DS/ISO 15674
Cardiovascular implants and artificial organs – Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
| Organization: | DS |
| Publication Date: | 31 August 2016 |
| Status: | active |
| Page Count: | 18 |
| ICS Code (Implants for surgery, prosthetics and orthotics): | 11.040.40 |
scope:
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.
Document History