ANSI/AAMI/ISO 7199:2016

ANSI/AAMI/ISO 7199:2016

Cardiovascular implants and artificial organs—Blood-gas exchangers (oxygenators)

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141,00 €

Détails

Specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). Applicable to all medical tubing intended for cardiopulmonary bypass (CPB) and/or extracorporeal membrane oxygenation (ECMO), but specific requirements and tests are included for tubing intended for use with peristaltic pumps during (short-term, i.e. greater than 24 h) ECMO procedures. Sterility and non-pyrogenicity provisions of this document are applicable to tubing packs labelled as —sterile—. Annex 3

Informations supplémentaires

Auteur Association for the Advancement of Medical Instrumentation (AAMI)
Edité par AAMI
Type de document Norme
Thème Implants & Artificial Organs
Mot-clé ANSI/AAMI/ISO 7199:2016