ISO 15676:2016
ISO 15676:2016 Cardiovascular implants and artificial organs – Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
CDN $131.00
Description
ISO 15676:2016 specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). This document 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 this document are applicable to tubing packs labelled as “sterile”.
It 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.
Edition
2
Published Date
2016-08-15
Status
PUBLISHED
Pages
8
Language
English
Format
Secure PDF
Secure – PDF details
- Save your file locally or view it via a web viewer
- Viewing permissions are restricted exclusively to the purchaser
- Device limits - 3
- Printing – Enabled only to print (1) copy
See more about our Environmental Commitment
Abstract
ISO 15676:2016 specifies requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). This document 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 this document are applicable to tubing packs labelled as "sterile".
It 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.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-
ISO 15416:2025 Automatic identification and data capture techniques – Bar code print quality test specification – Linear symbols
CDN $352.00 Add to cart -
ISO 17097:2024 3-D human body scan data – Methods for the processing of human body scan data
CDN $195.00 Add to cart -
ISO 20560:2024 Safety information for the content of piping systems and tanks – Part 1: Piping systems
CDN $263.00 Add to cart -
ISO 24096:2024 Technical product documentation (TPD) – Classification of requirements – Part 2: Classification based on severity and susceptibility
CDN $263.00 Add to cart
