This document 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.
Cross References:ISO 17665-1
ISO 10993-7
ISO 11607-1
ISO 10993-1
ISO 80369-7
ISO 10993-11
ISO 11607-2
ISO 11137-1
ISO 11135
ISO 14937
ISO 7199
ISO 13485
ISO 14971
ISO 594-2
PD ISO/TS 23810:2018
ISO/TS 23810:2018
ISO 8637-1:2017
Incorporates the following:Amendment, February 2020
| File Size : | 1
file
, 2.4 MB |
| ISBN(s) : | 9780580518256 |
| Note : | This product is unavailable in Russia, Ukraine, Belarus |
| Number of Pages : | 28 |
| Product Code(s) : | 30368449, 30368449, 30368449 |
| Published : | 02/19/2020 |
