ISO 15674:2016
Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
OVERVIEW
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.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2016 |
| No. of Pages | 11 |
| ICS Classification | 11.040.40 Implants for surgery, prosthetics and orthotics |
| Committee | ISO/TC 150/SC 2 |
| Available for Purchase | For sale in Singapore only |
| Adoption | ISO |