Abstract
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.
-
Status: WithdrawnPublication date: 2005-07
-
Edition: 1Number of pages: 8
-
- ICS :
- 11.040.40 Implants for surgery, prosthetics and orthotics
Life cycle
-
Now
-
Revised by
PublishedISO 15676:2016
Got a question?
Check out our FAQs
Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)