ISO 15676:2016
Current
The latest, up-to-date edition.
Cardiovascular implants and artificial organs — Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)
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15-08-2016
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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. 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.
| Committee |
ISO/TC 150/SC 2
|
| DevelopmentNote |
Supersedes ISO/DIS 15676. (08/2016)
|
| DocumentType |
Standard
|
| Pages |
8
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NEN ISO 15676 : 2016 | Identical |
| ANSI/AAMI/ISO 15676:2016 | Identical |
| ABNT NBR ISO 15676:2023 | Identical |
| BS ISO 15676:2016 | Identical |
| ISO 11658:2012 | Cardiovascular implants and extracorporeal systems — Blood/tissue contact surface modifications for extracorporeal perfusion systems |
| BS ISO 11658:2012 | Cardiovascular implants and extracorporeal systems. Blood/tissue contact surface modifications for extracorporeal perfusion systems |
| ANSI/AAMI/ISO 11658:2012 | CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - BLOOD/TISSUE CONTACT SURFACE MODIFICATIONS FOR EXTRACORPOREAL PERFUSION SYSTEMS |
| 11/30227618 DC : 0 | BS ISO 11658 - CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - BLOOD/TISSUE CONTACT SURFACE MODIFICATIONS FOR EXTRACORPOREAL PERFUSION SYSTEMS |
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| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 14937:2009 | Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices |
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| ISO 34-1:2015 | Rubber, vulcanized or thermoplastic Determination of tear strength Part 1: Trouser, angle and crescent test pieces |
| ISO 10993-11:2017 | Biological evaluation of medical devices — Part 11: Tests for systemic toxicity |
| ISO 10993-7:2008 | Biological evaluation of medical devices Part 7: Ethylene oxide sterilization residuals |
| ISO 11137-2:2013 | Sterilization of health care products — Radiation — Part 2: Establishing the sterilization dose |
| ISO 10993-1:2009 | Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ASTM D 638 : 2014 : REDLINE | Standard Test Method for Tensile Properties of Plastics |
| ISO 17665-1:2006 | Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices |
| ISO 527-1:2012 | Plastics Determination of tensile properties Part 1: General principles |
| ISO 868:2003 | Plastics and ebonite — Determination of indentation hardness by means of a durometer (Shore hardness) |
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