1、ANSI/AAMI/ISO 8836: 2015Suction catheters for use in the respiratory tractAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an AAMI product standard or recommended practice are clearly understood.
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4、 for a medical device recommends to the manufacturer the information that should be provided with or on the product, basic safety and performance criteria that should be considered in qualifying the device for clinical use, and the measurement techniques that can be used to determine whether the dev
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7、se tests can represent a considerable part of committee work. When a drafting committee determines that clinical concerns warrant the establishment of minimum safety and performance criteria, referee tests must be provided and the reasons for establishing the criteria must be documented in the ratio
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21、rmation and policy guidance and in the context of professional experience and judgment. INTERPRETATIONS OF AAMI STANDARDS AND RECOMMENDED PRACTICES Requests for interpretations of AAMI standards and recommended practices must be made in writing, to the AAMI Vice President, Standards Policy and Progr
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23、 notice of interpretation in the “Standards Monitor“ section of the AAMI News. The Association for the Advancement of Medical Instrumentation disclaims responsibility for any characterization or explanation of a standard or recommended practice which has not been developed and communicated in accord
24、ance 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 8836:2015 Suction catheters for use in the respiratory tract Approved 4 November 2015 by Association for the Advancement of Medical Ins
25、trumentation Approved 29 December 2015 by American National Standards Institute Abstract: Specifies requirements for suction catheters, including closed suction catheters, made of flexible materials and intended for use in suctioning of the respiratory tract. Angled-tip suction catheters (e.g. Coud
26、catheters) and suction catheters with aspirator collectors are not considered to be specialized and are therefore included in the scope of this International Standard. AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substanti
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31、 of its rules and regulations. Published by AAMI 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 HUwww.aami.orgUH 2017 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of ISO and AAMI. No part of this publ
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33、rt of this document (whether internally or externally) without the prior written permission of the Association for the Advancement of Medical Instrumentation. Violators risk legal action, including civil and criminal penalties, and damages of $100,000 per offense. For permission regarding the use of
34、 all or any part of this document, complete the reprint request form at HUwww.aami.orgUH or contact AAMI at 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-276-0793. Printed in the United States of America ISBN 978-1-57020-607-8 Contents PageGlossary o
35、f equivalent standards v Committee representation . vi Background of ANSI/AAMI adoption of ISO 8836:2014 viii Foreword . ix Introduction x 1 Scope. 1 2 Normative references. 1 3 Terms and definitions. 2 4 *General requirements for open and closed suction catheters 5 4.1 Risk management 5 4.2 Safety
36、6 5 Specific requirements for open and closed suction catheters 6 5.1 Size and length designations . 6 5.2 *Dimensions 6 6 Materials 7 7 *Design 8 7.1 Lumen of the suction catheter . 8 7.2 Suction catheter tip 8 7.3 *Suction catheter connector. 8 7.4 Additional requirements for closed suction cathet
37、ers 10 7.4.1 General design 10 7.4.2 *Patient end adaptor and connectors for the closed suction catheter . 107.4.3 Protective sleeve . 11 7.4.4 Vacuum control device for closed suction catheters 11 7.4.5 Flushing system for closed suction catheters 12 7.4.6 T-piece cap . 128 Performance requirements
38、 12 8.1 Security of construction . 12 8.2 Shaft performance . 12 8.3 *Vacuum control device performance 13 8.4 *Leakage . 13 8.5 *Resistance to flow 13 8.6 *Radiopacity 13 9 Requirements for suction catheters supplied sterile 14 9.1 Sterility assurance . 14 9.2 Packaging of suction catheters supplie
39、d sterile . 14 10 Marking 14 10.1 Marking on suction catheters . 14 10.2 Use of symbols 15 10.3 Labelling of individual packs 15 10.4 Labelling of shelf/multi-unit packs 16 Annex A (informative) Rationale 17 Annex B (normative) Test method for security of attachment . 20 Annex C (normative) Measurem
40、ent of residual vacuum . 21 Annex D (normative) Method of testing leakage . 23 Annex E (informative) Hazard identification for risk assessment. 24 Bibliography . 26 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 8836:2015 v Glossary of equivalent standards Internationa
41、l 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). Available on the AAMI website at the address below, this list gives the corresponding U.S
42、. designation and level of equivalency to the International Standard. www.aami.org/standards/glossary.pdf vi 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 8836:2015 Committee representation Association for the Advancement of Medical Instrumentation Anaesthetic and Res
43、piratory Equipment Committee The publication of ANSI/AAMI/ISO 8836 as a new American National Standard was initiated by the AAMI Anaesthetic and Respiratory Equipment Committee, which also functions as a U.S. Technical Advisory Group to the relevant work in the International Organization for Standar
44、dization (ISO). At the time this document was published, the AAMI Anaesthetic and Respiratory Equipment Committee had the following members: (to be formatted prior to publication) Cochairs: Julian Goldman, Massachusetts General Hospital David Carr, Teleflex Medical Members: Mark Allen, Atlas Copco D
45、avid Arney, University of Pennsylvania Len Berman, Pall Medical Lee Birch, Luxfer Gas Cylinders Frank Block Steve Briol, Nonin Medical Inc William Burns, Piramal Critical Care Inc Yu Chen, Draeger, Medical Systems Inc Daniel Cook, Cookgas Claire Couch, Halyard Health Todd Courtney, FDA/CDRH Steven D
46、ain, University of Western Ontario Rick Dodd, GE Healthcare Jerry Dorsch, Mayo Clinic Susan Dorsch Paul Dryden, ProMedic Inc Cindy Engelhardt, Smiths Medical David Feinstein, Beth Israel Deaconess Medical Center John Hedley-Whyte, Harvard University Mike Jaffe, Cardiorespiratory Consulting LLC Bob K
47、opotic, CAS Medical Systems Inc Robert McCoy, Valley Inspired Products Robert McKennett, Bayhealth Medical Center Tim Morris, Medline Industries Inc Dave Osborn, Philips Electronics North America James Philip, Brigham it may additionally be expressed in French (Charriere) gauge size (see Table 1). N
48、OTE 1 For the purposes of this International Standard, the French gauge system of size (F) is based on the outside diameter of the shaft gauged in steps of thirds of a millimetre (1 mm corresponds to 3F). NOTE 2 The French gauge size is not an SI unit. Size designation in millimetres facilitates mat
49、ching the suction catheter outside diameter to the inside diameter of the tracheal or tracheostomy tube. 5.1.2 The size of the suction catheter shall also be designated by use of colour identification at the machine end in accordance with Table 1, for the designated sizes listed. 5.1.3 The use and choice of colour identification for designated sizes not listed in Table 1 are at the manufacturers discretion. 5.1.4 The length of the suction catheter shall be designated by the nominal shaft length, expressed in millimetres. 5.2 *Dimensions 5.2.1 The outside diameter of the shaft
