BS ISO 15676:2016
$102.76
Cardiovascular implants and artificial organs. Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
| Published By | Publication Date | Number of Pages |
| BSI | 2016 | 20 |
This document 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”.
This document 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.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 6 | Foreword |
| 7 | Introduction |
| 9 | 1 Scope 2 Normative references |
| 10 | 3 Terms and definitions |
| 11 | 4 Requirements 4.1 Biological characteristics 4.1.1 Sterility and non-pyrogenicity 4.1.2 Biocompatibility 4.2 Physical characteristics 4.2.1 General 4.2.2 Dimensions 4.2.3 Material properties 4.3 Performance characteristics 4.3.1 Priming volume |
| 12 | 4.3.2 Life to failure testing 4.3.3 Spallation 4.3.4 Shelf life 5 Tests and measurements 5.1 General 5.2 Biological characteristics 5.2.1 Sterility and non-pyrogenicity 5.2.2 Biocompatibility |
| 13 | 5.3 Physical characteristics 5.3.1 Blood pathway integrity 5.3.2 Connections 5.3.3 Tubing material property testing 5.4 Performance characteristics 5.4.1 Tubing life 5.4.2 Spallation in tubing used in roller pumps |
| 14 | 5.4.3 Shelf life 6 Information supplied by the manufacturer 6.1 Information on the tubing pack 6.1.1 Information on the unit container 6.1.2 Information on the shipping container |
| 15 | 6.2 Information on the accompanying documents 6.3 Information in the accompanying documents in a prominent form 6.4 Information to be provided by manufacturer upon request 7 Packaging |
| 16 | Bibliography |
