1、ANSI/AAMI/ISO 80369-1:2010Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirementsAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an AAMI product stan
2、dard 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 increase in the safe and effective application of current techno
3、logies 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 attention to these objectives and provided that arbitrary a
4、nd restrictive uses are avoided. A voluntary 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 tec
5、hniques that can be used to determine 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,
6、 instructions for use, warnings and 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 facilita
7、te uniformity in reporting; reaching 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 esta
8、blishing the criteria must be documented 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
9、a device is used safely and effectively 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
10、recommended practice is usually oriented 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 in
11、dustrial personnel on such subjects 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 determi
12、ning whether an AAMI standard or recommended 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 proc
13、urement authorities). The application 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 r
14、epresentatives, whose work has been 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
15、is limited, however, in the sense that 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.
16、 Despite periodic review and revision (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 rationa
17、le for each of its provisions. This 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
18、. While observed or potential risks 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
19、 product as “unsafe“. A voluntary standard 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
20、 of the specific needs and resources 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
21、 it is used in conjunction with other 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, t
22、o the AAMI Vice President, Standards 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 u
23、pon exhaustion of any appeals and upon 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 wh
24、ich 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 80369-1:2010 Smallbore connectors for liquids and gases in healthcare applications
25、 - Part 1: General requirements Approved 8 December 2010 by Association for the Advancement of Medical Instrumentation Approved 30 December 2010 by American National Standards Institute, Inc. Abstract: This covers general aspects of non-interchangeability and appropriate validation procedures for sm
26、all bore connectors for liquids and gases in healthcare applications. Keywords: liquids, gases, small bore connectors AAMI Standard This Association for the Advancement of Medical Instrumentation (AAMI) standard implies a consensus of those substantially concerned with its scope and provisions. The
27、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 periodic review, and users are c
28、autioned 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 five years from the date of publication. Interested parties may obtain current
29、 information on all AAMI standards by calling or writing AAMI, or by visiting the AAMI website at www.aami.org. All AAMI standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are voluntary, and their application is solely within the
30、 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 regulations. Published by Associa
31、tion for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2011 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Printed in the United States of America ISBN 1570204055 This publication is subject to
32、 copyright claims of ISO and AAMI. No part of this publication 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 (
33、17 U.S.C. 101, et seq.) to make copies of all or any part 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 $1
34、00,000 per offense. For permission regarding the use of all or any part of this document, complete the reprint request form at www.aami.org or contact AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: (703) 525-4890; Fax: (703) 276-0793. DISCLAIMER The standards of the Associa
35、tion for the Advancement of Medical Instrumentation (AAMI), including the standards on small-bore connectors (AAMI/ISO 80369 series), are developed through a voluntary consensus standards development process approved by the American National Standards Institute. This process brings together voluntee
36、rs and seeks out the views of persons who have an interest in the subject of the standard(s), in this case small-bore connectors, in order to achieve consensus on the topic and related health and safety issues. AAMI administers the process and establishes rules to promote fairness in the development
37、 of consensus. The AAMI Foundation is helping to fund the costs of testing for the proposed standards on small-bore connectors by an independent organization. AAMI and the AAMI Foundation will not write the standards on small-bore connectors and will not independently test, evaluate, or verify the a
38、ccuracy or completeness of any information or the soundness of any judgments contained in any draft or final standards on small-bore connectors. AAMI and the AAMI Foundation disclaim liability for any personal injury, property, or other damages of any nature whatsoever, whether special, indirect, co
39、nsequential, or compensatory, directly or indirectly resulting from the publication, use of, application, or reliance on any draft or final standard on small-bore connectors. Further, AAMI and the AAMI Foundation disclaim and make no guaranty or warranty, expressed or implied, as to the accuracy or
40、completeness of any information published in the draft or final standards on small-bore connectors, and disclaim and make no warranty that the information in the draft or final standards will fulfill any of your particular purposes or needs or those of your company or association. AAMI and the AAMI
41、Foundation do not undertake to guarantee the performance of any individual manufacturer or sellers products or services by virtue of this standard. In publishing and making any draft or final standard on small-bore connectors available, AAMI and the AAMI Foundation are not undertaking to render prof
42、essional or other services for or on behalf of any person or entity, nor are AAMI and the AAMI Foundation undertaking to perform any duty owed by any person or entity to someone else. Anyone using the standards should rely on his or her own independent judgment or, as appropriate, seek the advice of
43、 a competent professional in determining the exercise of reasonable care in any given circumstances. Information on the topic of small-bore connectors may be available from other sources, which the user may wish to consult for additional views or information not covered by the draft or final standar
44、ds. AAMI and the AAMI Foundation have no power to, nor do they undertake to, police or enforce compliance with the contents of this standard. AAMI and the AAMI Foundation do not certify, test, or inspect products, designs, or installations for safety or health purposes. Any certification or other st
45、atement of compliance with any health or safetyrelated information in the standards shall not be attributable to AAMI or the AAMI Foundation and is solely the responsibility of the certifier or maker of the statement. Contents Page 1 Scope. 1 2 Normative references 2 3 Terms and definitions 2 4 Mate
46、rials used for SMALL-BORE CONNECTORS 4 5 Requirements for SMALL-BORE CONNECTORS for specific APPLICATIONS 4 5.1 SMALL-BORE CONNECTOR incompatibility . 4 5.2 BREATHING SYSTEMS and driving gases APPLICATIONS. 4 5.3 Enteral and gastric APPLICATIONS 4 5.4 Urethral and urinary APPLICATIONS 5 5.5 Limb cuf
47、f inflation APPLICATIONS . 5 5.6 Neuraxial APPLICATIONS 5 5.7 Intravascular or hypodermic APPLICATIONS 5 5.8 Alternative SMALL-BORE CONNECTORS. 5 6 Additional SMALL-BORE CONNECTOR APPLICATIONS . 6 7 PROCEDURE to assess a proposed new design of SMALL-BORE CONNECTOR for inclusion in this series of sta
48、ndards 6 7.1 General 6 7.2 Proposal initiation 6 7.3 PROCEDURE to assess acceptability and NON-INTERCONNECTABLE characteristics 7 7.3.1 Design . 7 7.3.2 Design realization 7 7.3.3 Design VERIFICATION 7 7.3.4 Design validation . 8 7.4 Design review . 8 7.5 Subsequent parts of this series of standards
49、. 8 Annex A (informative) Rationale 9 Annex B (normative) Mechanical tests for verifying NON-INTERCONNECTABLE characteristics . 12 Annex C (informative) APPLICATIONS of SMALL-BORE CONNECTORS 13 Annex D (informative) Reference to the Essential Principles. 15 Bibliography 17 Terminology Alphabetized index of defined terms 18 Glossary of equivalent standards vi Committee representation. viii Background of AAMI adoption of ISO 80369-1:2010 . x Foreword . xiIntroduction . xiivi 2011 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 80369-1:2010 Glossary o
