1、ANSI/AAMI/ISO 80369-7: 2016Small-bore connectors for liquids and gases in healthcare applicationsPart 7: Connectors for intravascular or hypodermic applicationsAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and poten
2、tial 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 increase in the safe and effect
3、ive 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 attention to these objecti
4、ves and provided that arbitrary and 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 clin
5、ical use, and the measurement techniques 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, inclu
6、ding performance characteristics, 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 spe
7、cialized test methods to facilitate 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
8、provided and the reasons for establishing 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 prac
9、tices that will help ensure that 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 eval
10、uation. Similarly, even though a 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 c
11、riteria, provide guidelines to industrial 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
12、 industrial practices. In determining 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
13、 by government regulatory or procurement 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 ca
14、re professionals and industrial representatives, 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
15、standard or recommended practice 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 rep
16、lace responsible decision-making. 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 d
17、eveloped and the specific rationale 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
18、 current procedures and practices. 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 wi
19、ll serve to identify a particular 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
20、should be analyzed in the context 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 p
21、ractice is truly useful only when 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 pra
22、ctices must be made in writing, to 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 represe
23、ntation of the Association only upon 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 st
24、andard 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 80369-7:2016 Small-bore connectors for liquids an
25、d gases in healthcare applicationsPart 7: Connectors for intravascular or hypodermic applications Approved 2 September 2016 by Association for the Advancement of Medical Instrumentation Approved 27 September 2016 by American National Standards Institute Abstract: Specifies dimensions and requirement
26、s for the design and functional performance of small-bore connectors intended to be used for connectors in intravascular applicationsS or hypodermic connections in hypodermic applications of medical devices and accessories. AAMI Standard This Association for the Advancement of Medical Instrumentatio
27、n (AAMI) standard implies a consensus of those substantially 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
28、 procedures not conforming to the standard. AAMI standards 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
29、this standard no later than five years from the date of publication. Interested parties may obtain current information on all AAMI standards by calling or writing AAMI. All AAMI standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI
30、are voluntary, 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 enfor
31、cement of its rules and regulations. Published by AAMI 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 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 pu
32、blication 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
33、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 $100,000 per offense. For permission regarding the use
34、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: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 978-1-57020-674-0 Contents Page Glossary of e
35、quivalent standards . iv Committee representation. v Background of AAMI/ISO 80369-7:2016 . vii Foreword viii Introduction x 1 * Scope . 1 2 Normative references . 1 3 Terms and definitions . 2 4 General requirements . 3 5 * Dimensional requirements for LUER CONNECTORS 4 6 Performance requirements 4
36、Annex A (informative) Rationale and guidance . 6 Annex B (normative) LUER CONNECTORS . 10 Annex C (normative) Reference CONNECTORS . 22 Annex D (informative) Assessment of MEDICAL DEVICES and their attributes with CONNECTIONS within this APPLICATION 29 Annex E (informative) Summary of the usability
37、requirements for LUER CONNECTORS for intravascular or hypodermic APPLICATIONS . 31 Annex F (informative) Summary of LUER CONNECTOR design requirements for intravascular or hypodermic APPLICATIONS . 36 Annex G (informative) Summary of assessment of the design of the LUER CONNECTOR for intravascular o
38、r hypodermic APPLICATIONS . 39 Annex H (informative) Reference to the essential principles . 42 Annex I (informative) TerminologyAlphabetized index of defined terms 43 Bibliography . 45 iv 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 80369-7:2016 Glossary of equivale
39、nt 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). Available on the AAMI website at the address below, this list gi
40、ves 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/ISO 80369-7:2016 v Committee representation Association for the Advancement of Medical Instrume
41、ntation Quality Management and Corresponding General Aspects for Medical Devices Committee The publication of AAMI/ISO 80369-5 as a new American National Standard was initiated by the AAMI Quality Management and Corresponding General Aspects for Medical Devices Committee, which also functions as a U
42、.S. Technical Advisory Group to the relevant work in the International Organization for Standardization (ISO). U.S. representatives from the AAMI Small Bore Connectors Committee, chaired by Scott Colburn of FDA and Brad Noe of Becton Dickinson John Miskovic, Hospira; Kyle Steele, Nordson Medical; Ro
43、bert Virag, TRIFID Medical Medical Group LLC and especially Weston Harding, Becton Dickinson, for their contributions as CAD (computer-aided design) experts to the development of this standard. Their extraordinary commitment of time and effort attests to their dedication to patient safety and is gre
44、atly appreciated. 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 80369-7:2016 vii Background of AAMI/ISO 80369-7:2016 As indicated in the foreword to the main body of this document (page viii), the International Organization for Standardization (ISO) is a worldwide fed
45、eration 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 a joint ISO and International Electrotechnical Commission (IEC) working group, ISO/TC 210-IEC/SC 62D/JWG4, Small-bore connectors. U.S
46、. participation in ISO/TC 210-IEC/SC 62D/JWG4 is organized through the U.S. Technical Advisory Group to ISO/TC 210-IEC/SC 62D/JWG4, administered by the Association for the Advancement of Medical Instrumentation. Experts from the United States made a considerable contribution to this standard. As use
47、d within the context of this document, “shall” indicates requirements strictly to be followed to conform to the standard. “Should” indicates that among several possibilities, one is recommended as particularly suitable, without mentioning or excluding others, or that a certain course of action is pr
48、eferred but not necessarily required, or that (in the negative form) a certain possibility or course of action should be avoided but is not prohibited. “May” is used to indicate that a course of action is permissible within the limits of the standard. “Can” is used as a statement of possibility and
49、capability. Finally, “must” is used only to describe “unavoidable” situations, including those mandated by government regulation. NOTE Users of this standard are advised that this document is an AAMI identical adoption of an ISO document and that the following international conventions have been carried over to the AAMI publication: British English spelling (e.g. colour instead of color) Use of SI units (e.g. metres instead of feet, Celsius instead of Fahrenheit, etc.) Decimal comma instead of a decimal point (e.g. 1 000,15 instead of 1,000.15) The concepts incorpor
