1、ANSI/AAMI/ISO 80369-6: 2016Small-bore connectors for liquids and gases in healthcare applications Part 6: Connectors for neuraxial applicationsAmerican National StandardObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an A
2、AMI 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 effective application o
3、f 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 objectives and provided
4、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 clinical use, and the
5、 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, including performance
6、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 specialized test met
7、hods 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 provided and the
8、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 practices that will h
9、elp 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 evaluation. Similarly
10、, 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 criteria, provide
11、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 industrial pract
12、ices. 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 by government re
13、gulatory 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 care professionals
14、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 standard or recom
15、mended 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 replace responsible
16、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 developed and the
17、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 current procedur
18、es 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 will serve to ident
19、ify 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 should be analyze
20、d 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 practice is truly
21、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 practices must be ma
22、de 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 representation of the As
23、sociation 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 standard or recomme
24、nded 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 80369-6:2016 Small-bore connectors for liquids and gases in health
25、care applications Part 6: Connectors for neuraxial applications Approved 18 December 2015 by Association for the Advancement of Medical Instrumentation Approved 15 March 2016 by American National Standards Institute Abstract: Specifies requirements for SMALL-BORE CONNECTORS intended to be used for C
26、ONNECTIONS in neuraxial APPLICATIONS. Neuraxial APPLICATIONS involve the use of MEDICAL DEVICES intended to administer medications to neuraxial sites, wound infiltration anaesthesia delivery, and other regional anaesthesia procedures or to monitor or remove cerebro-spinal fluid for therapeutic or di
27、agnostic purposes. Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2016 by the Association for the Advancement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims
28、 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 (17 U.S.C. 101, et
29、 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 $100,000 per offens
30、e. 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: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 1-57020-6
31、05-8 Contents Page Glossary of equivalent standards iv Committee representation v Background of ANSI/AAMI/ISO 80369-6:2016 . vii Foreword viii Introduction . ix 1 * Scope 12 Normative references. 1 3 Terms and definitions. 2 4 General requirements 3 4.1 General requirements for the neuraxial APPLICA
32、TION 3 4.2 * Material used for SMALL-BORE CONNECTORS 44.3 TYPE TESTS . 4 5 Dimensional requirements for neuraxial SMALL-BORE CONNECTORS . 4 6 Performance requirements 4 6.1 Fluid leakage . 4 6.1.1 Fluid leakage requirement . 4 6.1.2 Leakage by pressure decay 4 6.1.3 Positive pressure liquid leakage
33、4 6.2 Subatmospheric pressure air leakage . 4 6.3 Stress cracking 5 6.4 Resistance to separation from axial load . 5 6.5 Resistance to separation from unscrewing 5 6.6 Resistance to overriding 5 Annex A (informative) Rationale and guidance . 6 Annex B (normative) * SMALL-BORE CONNECTORS for neuraxia
34、l APPLICATIONS . 10 Annex C (normative) Reference CONNECTORS for testing SMALL-BORE CONNECTORS for neuraxial APPLICATIONS . 19 Annex D (informative) Assessment of MEDICAL DEVICES and their attributes with CONNECTIONS within this APPLICATION 26 Annex E (informative) Summary of the usability requireme
35、nts for SMALL-BORE CONNECTORS for neuraxial APPLICATIONS 28 Annex F (informative) Summary of SMALL-BORE CONNECTOR design requirements for neuraxial APPLICATIONS. 31 Annex G (informative) Summary of assessment of the design of the SMALL BORE CONNECTORS for neuraxial APPLICATIONS 35 Annex H (normative
36、) Mechanical tests for verifying NON-INTERCONNECTABLE characteristics . 39 Annex I (informative) Reference to the essential principles 42 Annex J (informative) Terminology alphabetized index of defined terms 44 Bibliography . 46 iv 2016 Association for the Advancement of Medical Instrumentation ANSI
37、/AAMI/ISO 80369-6:2016 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 been adopted by AAMI (and ANSI). Available on the AAMI
38、 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 2016 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 80369-6:2016 v Committee representation Associat
39、ion for the Advancement of Medical Instrumentation Quality Management and Corresponding General Aspects for Medical Devices Committee The publication of ANSI/AAMI/ISO 80369-6 as a new American National Standard was initiated by the AAMI Quality Management and Corresponding General Aspects for Medica
40、l Devices Committee, which also functions as a U.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 (U.S. Sub-TAG for ISO/TC 210/JWG 04), chaired by Scott Colburn of FDA and
41、Brad Noe of Becton Dickinson John Miskovic, Hospira; Kyle Steele, Nordson Medical; Robert 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 c
42、ommitment of time and effort attests to their dedication to patient safety and is greatly appreciated. 2016 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 80369-6:2016 vii Background of ANSI/AAMI/ISO 80369-6:2016 As indicated in the foreword to the main body of this documen
43、t (page viii), the International Organization for Standardization (ISO) is a worldwide federation 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 Electrotechni
44、cal Commission (IEC) working group, ISO/TC 210-IEC/SC 62D/JWG4, Small-bore connectors. U.S. participation in ISO/TC 210-IEC/SC 62D/JWG4 is organized through the U.S. sub-Technical Advisory Group to ISO/TC 210-IEC/SC 62D/JWG4, administered by the Association for the Advancement of Medical Instrumenta
45、tion. Experts from the United States made a considerable contribution to this standard. This standard replaces AAMI/CN6, Small-bore connectors for liquids and gases in healthcare applications Part 6: Connectors for neuraxial applications. As used within the context of this document, “shall” indicate
46、s 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 preferred but not necessarily required, or that (in the n
47、egative 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 capability. Finally, “must” is used only to describe “u
48、navoidable” situations, including those mandated by government regulation. The concepts incorporated in this standard should not be considered inflexible or static. This standard, like any other, must be reviewed and updated periodically to assimilate progressive technological developments. To remai
49、n relevant, it must be modified as technological advances are made and as new data come to light. Suggestions for improving this standard are invited. Comments and suggested revisions should be sent to Standards Department, AAMI, 4301 N. Fairfax Dr, Suite 301, Arlington, VA 22203-1633. viii 2016 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 80369-6:2016 Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standard
