1、ANSI/AAMI/ISO 5367: 2015Anaesthetic and respiratory equipment Breathing sets and connectorsAmerican 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 cle
2、arly 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 increase in the safe and effective application of current technologies to patient care, and (2) the
3、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 attention to these objectives and provided that arbitrary and restrictive uses are avoided. A v
4、oluntary standard 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 determin
5、e whether the device 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
6、precautions, and 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
7、 consensus on these 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 docume
8、nted in the rationale. 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 effectiv
9、ely and that its 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 orie
10、nted towards healthcare 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
11、as sterilization 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 rec
12、ommended practice 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 applicatio
13、n of a standard or 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
14、reviewed nationally (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 th
15、at it responds generally 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 revisio
16、n (at least once 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
17、review will reveal 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
18、with existing equipment 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 st
19、andard can be used 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
20、 of the individual 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 othe
21、r sources of information 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
22、 Policy and Programs. 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 up
23、on publication of 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 commu
24、nicated 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 5367:2015 Anaesthetic and respiratory equipment Breathing sets and connectors Approved 4 November 2015 by AAMI Approve
25、d 29 December 2015 by American National Standards Institute Abstract: Specifies basic requirements for breathing sets and breathing tubes intended to be used with anaesthetic breathing systems, ventilator breathing systems, humidifiers or nebulizers. Applies to breathing sets and breathing tubes and
26、 patient end adaptors supplied already assembled and to those supplied as components and assembled in accordance with the manufacturers instructions. AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concerned wit
27、h 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 standards are subject to
28、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 publication. Interest
29、ed 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 voluntary, and their
30、 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 of its rules and
31、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 publication may be rep
32、roduced 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 part of this documen
33、t (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 all or any part o
34、f 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 978-1-57020-606-1 Contents Page Glossary of equivalent stan
35、dards iv Committee representation . v Background of ANSI/AAMI adoption of ISO 5367:2014 vii Foreword viii Introduction . ix 1 Scope 1 2 Normative references 1 3 Terms and definitions 2 4 General requirements 4 5 Specific requirements . 5 6 Prevention of electrostatic charges . 9 7 Requirements for b
36、reathing sets and breathing tubes supplied sterile . 9 8 Marking . 9 Annex A (informative) Rationale 13 Annex B (informative) Hazard identification for risk assessment 21 Annex C (normative) Test for security of attachment of plain end to conical connector . 22 Annex D (normative) Test for security
37、of attachment of adaptor to breathing tube . 23 Annex E (normative) Test for leakage . 24 Annex F (normative) Measurement of resistance to flow 26 Annex G (normative) Test for increase in flow resistance with bending . 29 Annex H (normative) Test for compliance 31 Bibliography . 33 iv 2017 Associati
38、on for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 5367:2015 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 bee
39、n adopted by AAMI (and ANSI). Available 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/I
40、SO 5367:2015 v Committee representation Association for the Advancement of Medical Instrumentation Anaesthetic and Respiratory Equipment Committee The publication of ANSI/AAMI/ISO 5367 as a new American National Standard was initiated by the AAMI Anaesthetic and Respiratory Equipment Committee, whic
41、h also functions as a U.S. Technical Advisory Group to the relevant work in the International Organization for Standardization (ISO). At the time this document was published, the AAMI Anaesthetic and Respiratory Equipment Committee had the following members: Cochairs: Julian Goldman, Massachusetts G
42、eneral Hospital David Carr, Teleflex Medical Members: Mark Allen, Atlas Copco David 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 Dan
43、iel Cook, Cookgas Claire Couch, Halyard Health Todd Courtney, FDA/CDRH Steven Dain, 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 Hedl
44、ey-Whyte, Harvard University Mike Jaffe, Cardiorespiratory Consulting LLC Bob Kopotic, 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 add
45、itional normative references; additional terms and definitions; additional general requirements, including risk management, usability, clinical and biophysical research; requirements for coaxial tubing, revised leakage limits, and testing for flow resistance and compliance; revised limits for preven
46、tion of electrostatic charges; revised requirements for marking of packaging, including the use of symbols, disclosure of intended patient category, flow resistance and compliance; added an annex for rationale; added an annex for hazard identification for risk assessment; revised test method annexes
47、 for resistance to flow, security of attachments, leakage and compliance; added an annex for compliance with the EU Directives. 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 5367:2015 ix Introduction This International Standard contains requirements for breathing sets
48、, breathing tubes, and connectors that are intended to function as accessories to anaesthetic and respiratory equipment. Breathing sets and breathing tubes are characterized by certain design requirements such as a means of connection and leakage limits. Disclosure requirements for compliance and fl
49、ow resistance values allow the user to make an informed choice when connecting these accessories to a breathing system. These design requirements are intended to allow operation within the limits of performance of the anaesthetic breathing systems and ventilator breathing systems with which the accessories are intended to operate. This International Standard includes requirements for both single-use and reusable breathing sets and breathing tubes. Re-usable breathing sets and breathing tubes are intended to comply with the requirements of this Intern
