95.99 Withdrawal of Standard Aug 15, 2016
ISO
ISO/TC 150/SC 2 Cardiovascular implants and extracorporeal systems
International Standard
11.040.40 Implants for surgery, prosthetics and orthotics
Withdrawn
ISO 15676:2005 specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). ISO 15676:2005 is 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. < 6 h duration) CPB surgery, or (long-term, i.e. > 24 h) ECMO procedures. The sterility and non-pyrogenicity provisions of ISO 15676:2005 are applicable to tubing packs labelled as "sterile".
ISO 15676:2005 is applicable only to the tubing aspects for multifunctional systems that may have integral components such as blood gas exchangers (oxygenators), reservoirs, blood filters, defoamers, blood pumps, etc.
WITHDRAWN
ISO 15676:2005
95.99
Withdrawal of Standard
Aug 15, 2016
PUBLISHED
ISO 15676:2016