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SSH ISO 15674:2016

Cardiovascular implants and artificial organs — Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags

Oct 29, 2018

General information

60.60     Aug 7, 2018

DPS

DPS/KT 206

International Standard

11.040.40  

English  

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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.

Life cycle

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PUBLISHED
SSH ISO 15674:2016
60.60 Standard published
Aug 7, 2018

Related project

Adopted from ISO 15674:2016