ANSI AAMI 8836-2015 Suction catheters for use in the respiratory tract.pdf

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.

2、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 increase in the safe and effective application of current technologies to patient care, and (2) the encouragement of

3、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 attention to these objectives and provided that arbitrary and restrictive uses are avoided. A voluntary standard

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

5、ice conforms with the safety and performance criteria and/or to compare the performance characteristics of different products. Some standards emphasize the information that should be provided with the device, including performance characteristics, instructions for use, warnings and precautions, and

6、other data considered important in ensuring the safe and effective use of the device in the clinical environment. Recommending the disclosure of performance characteristics often necessitates the development of specialized test methods to facilitate uniformity in reporting; reaching consensus on the

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

8、nale. A recommended practice provides guidelines for the use, care, and/or processing of a medical device or system. A recommended practice does not address device performance per se, but rather procedures and practices that will help ensure that a device is used safely and effectively and that its

9、performance will be maintained. Although a device standard is primarily directed to the manufacturer, it may also be of value to the potential purchaser or user of the device as a frame of reference for device evaluation. Similarly, even though a recommended practice is usually oriented towards heal

10、thcare professionals, it may be useful to the manufacturer in better understanding the environment in which a medical device will be used. Also, some recommended practices, while not addressing device performance criteria, provide guidelines to industrial personnel on such subjects as sterilization

11、processing, methods of collecting data to establish safety and efficacy, human engineering, and other processing or evaluation techniques; such guidelines may be useful to health care professionals in understanding industrial practices. In determining whether an AAMI standard or recommended practice

12、 is relevant to the specific needs of a potential user of the document, several important concepts must be recognized: All AAMI standards and recommended practices are voluntary (unless, of course, they are adopted by government regulatory or procurement authorities). The application of a standard o

13、r recommended practice is solely within the discretion and professional judgment of the user of the document. Each AAMI standard or recommended practice reflects the collective expertise of a committee of health care professionals and industrial representatives, whose work has been reviewed national

14、ly (and sometimes internationally). As such, the consensus recommendations embodied in a standard or recommended practice are intended to respond to clinical needs and, ultimately, to help ensure patient safety. A standard or recommended practice is limited, however, in the sense that it responds ge

15、nerally to perceived risks and conditions that may not always be relevant to specific situations. A standard or recommended practice is an important reference in responsible decision-making, but it should never replace responsible decision-making. Despite periodic review and revision (at least once

16、every five years), a standard or recommended practice is necessarily a static document applied to a dynamic technology. Therefore, a standards user must carefully review the reasons why the document was initially developed and the specific rationale for each of its provisions. This review will revea

17、l whether the document remains relevant to the specific needs of the user. Particular care should be taken in applying a product standard to existing devices and equipment, and in applying a recommended practice to current procedures and practices. While observed or potential risks with existing equ

18、ipment typically form the basis for the safety and performance criteria defined in a standard, professional judgment must be used in applying these criteria to existing equipment. No single source of information will serve to identify a particular product as “unsafe“. A voluntary standard can be use

19、d as one resource, but the ultimate decision as to product safety and efficacy must take into account the specifics of its utilization and, of course, cost-benefit considerations. Similarly, a recommended practice should be analyzed in the context of the specific needs and resources of the individua

20、l institution or firm. Again, the rationale accompanying each AAMI standard and recommended practice is an excellent guide to the reasoning and data underlying its provision. In summary, a standard or recommended practice is truly useful only when it is used in conjunction with other sources of info

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

22、ams. An official interpretation must be approved by letter ballot of the originating committee and subsequently reviewed and approved by the AAMI Standards Board. The interpretation will become official and representation of the Association only upon exhaustion of any appeals and upon publication of

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

27、ally concerned with its scope and provisions. The existence of an AAMI standard does not in any respect preclude anyone, whether they have approved the standard or not, from manufacturing, marketing, purchasing, or using products, processes, or procedures not conforming to the standard. AAMI standar

28、ds are subject to periodic review, and users are cautioned to obtain the latest editions. CAUTION NOTICE: This AAMI standard may be revised or withdrawn at any time. AAMI procedures require that action be taken to reaffirm, revise, or withdraw this standard no later than 5 years from the date of pub

29、lication. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI, or by visiting the AAMI website at HUwww.aami.orgUH. All AAMI standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are vo

30、luntary, and their application is solely within the discretion and professional judgment of the user of the document. Occasionally, voluntary technical documents are adopted by government regulatory agencies or procurement authorities, in which case the adopting agency is responsible for enforcement

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

32、ication may be reproduced or distributed in any form, including an electronic retrieval system, without the prior written permission of AAMI. All requests pertaining to this document should be submitted to AAMI. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of all or any pa

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