ANSI/AAMI/ISO 18241:2016
Current
The latest, up-to-date edition.
CARDIOVASCULAR IMPLANTS AND EXTRACORPOREAL SYSTEMS - CARDIOPULMONARY BYPASS SYSTEMS - VENOUS BUBBLE TRAPS
Hardcopy , PDF
English
07-11-2016
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Glossary of equivalent standards
Committee representation
Background of AAMI adoption of
ISO 18241:2016
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements
5 Tests and measurements to
determine compliance with this
document
6 Information supplied by the
manufacturer
7 Packaging
Bibliography
Describes requirements for sterile, single-use, venous bubble traps intended to remove air entering the venous line during surgical procedures requiring extracorporeal circulatory support, which may include cardiopulmonary bypass (CPB), extracorporeal membrane oxygenation (ECMO), or venovenous bypass for liver transplantation.
| Committee |
ISO/TC 150
|
| DocumentType |
Standard
|
| ISBN |
978-1-57020-634-4
|
| Pages |
22
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Standards | Relationship |
| ISO 18241:2016 | Identical |
| ISO 11137-1:2006 | Sterilization of health care products Radiation Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| ISO 10993-4:2017 | Biological evaluation of medical devices — Part 4: Selection of tests for interactions with blood |
| ISO 11607-2:2006 | Packaging for terminally sterilized medical devices Part 2: Validation requirements for forming, sealing and assembly processes |
| ISO 8637:2010 | Cardiovascular implants and extracorporeal systems Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators |
| 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 |
| ISO 11135-1:2007 | Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices |
| 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 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 |
| ISO 594-2:1998 | Conical fittings with 6 % (Luer) taper for syringes, needles and certain other medical equipment Part 2: Lock fittings |
| 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 |
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