AAMI/ISO 15674:2009
Cardiovascular implants and artificial organs - Hard shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags

Standard No.
AAMI/ISO 15674:2009
Release Date
2009
Published By
SCC
Status
Replace By
AAMI/ISO 15674:2016
Latest
AAMI/ISO 15674:2016
 
Scope
This standard 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.

AAMI/ISO 15674:2009 history

  • 2016 AAMI/ISO 15674:2016 Cardiovascular implants and artificial organs - Hard shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags
  • 2009 AAMI/ISO 15674:2009 Cardiovascular implants and artificial organs - Hard shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags

Standard and Specification

ANSI/AAMI/ISO 15674:2009 Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags DS/ISO 15674:2009 Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags ISO 15674:2001 Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags YY 0603-2007 Cardiovascular implants and artificial organs-Hard-shell cardiotomy/venous reservoir systems(with/without filter)and soft venous reservoir bags ISO 15674:2009 implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags BS ISO 15674:2009 Cardiovascular implants and artificial organs - Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags DANSK DS/ISO 15674:2016 Cardiovascular implants and artificial organs – Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags BS ISO 15674:2001 Cardiovascular implants and artificial organs. Hard-shell cardiotomy/venous reservoir systems (with/without filter) and soft venous reservoir bags BS ISO 15674:2016+A1:2020 Cardiovascular implants and artificial organs — Hard - shell cardiotomy / venous reservoir systems (with / without filter) and soft venous reservoir bags


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