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.
Status: PublishedPublication date: 2016-08
Edition: 3Number of pages: 11
Technical Committee: ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems
- ICS :
- 11.040.40 Implants for surgery, prosthetics and orthotics
This standard contributes to the following Sustainable Development Goal:
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|std 1 61||PDF + ePub|
|std 2 61||Paper|
A standard is reviewed every 5 years
Stage: 90.60 (Under review)
Corrigenda / AmendmentsPublished
ISO 15674:2016/Amd 1:2020
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