ANSI AAMI 15676-2016 Cardiovascular implants and artificial organs-Requirements for singleuse tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO).pdf

1、ANSI/AAMI/ISO 15676: 2016Cardiovascular implants and artificial organs Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO)American National StandardObjectives and uses of AAMI standards and recommended practices It is most important that

2、 the objectives and potential uses of an AAMI product standard or recommended practice are clearly understood. The objectives of AAMIs technical development program derive from AAMIs overall mission: the advancement of medical instrumentation. Essential to such advancement are (1) a continued increa

3、se in the safe and effective application of current technologies to patient care, and (2) the encouragement of new technologies. It is AAMIs view that standards and recommended practices can contribute significantly to the advancement of medical instrumentation, provided that they are drafted with a

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24、on or explanation of a standard or recommended practice which has not been developed and communicated in accordance with this procedure and which is not published, by appropriate notice, as an official interpretation in the AAMI News. American National Standard ANSI/AAMI/ISO 15676:2016 Cardiovascula

25、r implants and artificial organs Requirements for single-use tubing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO) Approved 2 September 2016 by AAMI Approved 18 November 2016 by American National Standards Institute Abstract: Specifies requirements for single-use tub

26、ing packs for cardiopulmonary bypass and extracorporeal membrane oxygenation (ECMO). 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 perista

27、ltic pumps during (short-term, i.e. 24 h) ECMO procedures. Sterility and non-pyrogenicity provisions of this document are applicable to tubing packs labelled as “sterile”. Keywords: biocompatibility, connections, filtration, flow, pyrogenicity, sterility AAMI Standard This Association for the Advanc

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32、ocurement authorities, in which case the adopting agency is responsible for enforcement of its rules and regulations. Published by AAMI 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 Uwww.aami.org 2017 by the Association for the Advancement of Medical Instrumentation All Rights Reserved T

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36、inted in the United States of America ISBN 978-1-57020-638-2 Contents Page Glossary of equivalent standards iv Committee representation . v Background of AAMI adoption of ISO 15676:2016 . vi Foreword . vii Introduction . viii 1 Scope 1 2 Normative references 1 3 Terms and definitions 2 4 Requirement

37、s . 3 4.1 Biological characteristics 3 4.2 Physical characteristics 3 4.3 Performance characteristics . 4 5 Tests and measurements 4 5.1 General . 4 5.2 Biological characteristics 4 5.3 Physical characteristics 5 5.4 Performance characteristics . 5 6 Information supplied by the manufacturer 6 6.1 In

38、formation on the tubing pack . 6 6.2 Information on the accompanying documents 7 6.3 Information in the accompanying documents in a prominent form 7 6.4 Information to be provided by manufacturer upon request . 7 7 Packaging . 8 Bibliography . 9 iv 2017 Association for the Advancement of Medical Ins

39、trumentation ANSI/AAMI/SO 15676:2016 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. AAMI maintains a current list of each International Standard that has been adopted by AAMI (and ANSI). Availab

40、le on the AAMI website at the address below, this list gives the corresponding U.S. designation and level of equivalency to the International Standard. www.aami.org/standards/glossary.pdf 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/SO 15676:2016 v Committee representati

41、on Association for the Advancement of Medical Instrumentation Blood/Gas Exchange Device Committee The adoption of ISO 15676:2016 as an American National Standard was initiated by the AAMI Blood/Gas Exchange Device Committee. The AAMI Blood/Gas Exchange Device Committee also functions as the U.S. Tec

42、hnical Advisory Group to the relevant work in the International Organization for Standardization (ISO). U.S. representatives from the AAMI Blood/Gas Exchange Device Committee (U.S. Sub-TAG for ISO/TC 150/SC 2/WG 4) played an active part in developing the ISO standard. At the time this document was p

43、ublished, the AAMI Blood/Gas Exchange Device Committee (U.S. Sub-TAG for ISO/TC 150/SC 2/WG 4) had the following members: Cochairs: Trevor Huang, PhD MBA Mark Kurusz, CCP Members: Richard Chan, CCP, Northshore University Hospital Drew Holmes, Baxter Healthcare Tsuyoshi Hosoi, Terumo Cardiovascular S

44、ystems Trevor Huang, PhD MBA, Medtronic Perfusion Systems George Silvay, MD PhD, Mount Sinai Medical Center Catherine Wentz, FDA/CDRH Alternates: David M. Fallen, CCP, Terumo Medical Qijin Lu, FDA/CDRH Rakesh Sethi, Medtronic NOTE Participation by federal agency representatives in the development of

45、 this standard does not constitute endorsement by the federal government or any of its agencies. vi 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/SO 15676:2016 Background of AAMI adoption of ISO 15676:2016 As indicated in the foreword to the main body of this document (pa

46、ge vii), the International Organization for Standardization (ISO) is a worldwide federation of national standards bodies. The United States is one of the ISO members that took an active role in the development of this standard, which was developed by ISO Technical Committee (TC) 150 Subcommittee (SC

47、) 2, Cardiovascular implants and extracorporeal systems, to ensure that medical grade tubing in single-use tubing packs for the transfer of blood and fluid during the period of cardiopulmonary bypass (CPB) and extracorporeal membrane oxygenation (ECMO) is adequately tested for both safety and functi

48、on. U.S. participation in this ISO SC is organized through the U.S. Technical Advisory Group for ISO/TC 150/SC 2, administered by the Association for the Advancement of Medical Instrumentation (AAMI). AAMI encourages its committees to harmonize their work with international standards as much as poss

49、ible. The U.S. adoption of ANSI/AAMI/ISO 15676:2016 was approved by the American National Standards Institute (ANSI) on 18 November 2016. The AAMI Blood/Gas Exchange Device Committee (U.S. Sub-TAG for ISO/TC 150/SC 2/WG 4, Blood/gas exchangers) initiated the U.S. adoption of ISO 15676:2016. AAMI and ANSI procedures require that standards be reviewed and, if necessary, revised every five years to reflect technological advances that may have occurred since publication. AAMI (and ANSI) have adopted other ISO standards. See the Glossary of Equivalent Standards for a list of IS