1、ANSI/AAMI/ISO 80369-20: 2015Small-bore connectors for liquids and gases in healthcare applications Part 20: Common test methodsAmerican 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 80369-20:2015 Small-bore connectors for liquids and gases in healthcare applicatio
25、ns Part 20: Common test methods Approved 30 March 2015 by Association for the Advancement of Medical Instrumentation Approved 20 April 2015 by American National Standards Institute, Inc. Abstract: Specifies the TEST METHODS to support the functional requirements for SMALL-BORE CONNECTORS intended to
26、 be used for CONNECTIONS of MEDICAL DEVICES and related ACCESSORIES. Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2015 by the Association for the Advancement of Medical Instrumentation All Rights Reserv
27、ed This publication is subject to 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.
28、It is illegal under federal law (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 crim
29、inal penalties, and damages of $100,000 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: +1-703-525-4890; Fax: +1-703-525-1067. Prin
30、ted in the United States of America ISBN 1-57020-591-4 Contents PageGlossary of equivalent standards iv Committee representation v Background of AAMI/ISO 80369-20:2015 vii Foreword viii Introduction . ix 1 *Scope . 12 Normative references. 1 3 Terms and definitions. 1 4 TEST METHODS for SMALL-BORE C
31、ONNECTORS 2 Annex A (informative) Rationale and guidance . 3 Annex B (normative) *Leakage by pressure decay TEST METHOD 6 Annex C (normative) Falling drop positive-pressure liquid leakage TEST METHOD 9 Annex D (normative) Subatmospheric-pressure air leakage TEST METHOD 11 Annex E (normative) Stress
32、cracking TEST METHOD . 15 Annex F (normative) Resistance to separation from axial load TEST METHOD 17 Annex G (normative) Resistance to separation from unscrewing TEST METHOD . 19 Annex H (normative) Resistance to overriding TEST METHOD . 21 Annex I (normative) Disconnection by unscrewing TEST METHO
33、D . 23 Annex J (informative) Modification of the TEST METHODS to generate variable data for statistical analysis 25 Annex K (informative) Terminology alphabetized index of defined terms . 27 Bibliography . 28 Glossary of equivalent standards International Standards adopted in the United States may i
34、nclude 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. designation and level of equivalency to the
35、International Standard. www.aami.org/standards/glossary.pdf iv 2015 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 80369-20:2015 Committee representation Association for the Advancement of Medical Instrumentation Quality Management and Corresponding General Aspects for Medi
36、cal Devices Committee The publication of AAMI/ISO 80369-20 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.S. Technical Advisory Group to the relevant work in the Internation
37、al 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 Brad Noe of Becton Dickinson informative material appearing outside of tables, such as notes, examples, and referenc
38、es: in smaller type. Normative text of tables is also in a smaller type; terms defined in ISO 80369-1 and Clause 3: small capitals. In this part of ISO 80369, the conjunctive “or” is used as an “inclusive or” so a statement is true if any combination of the conditions is true. The verbal forms used
39、in this International Standard conform to usage described in ISO/IEC Directives, Part 2, Annex H. For the purposes of this part of ISO 80369, the auxiliary verb “shall” means that compliance with a requirement or a test is mandatory for compliance with this part of ISO 80369, “should” means that com
40、pliance with a requirement or a test is recommended but is not mandatory for compliance with this part of ISO 80369, and “may” is used to describe a permissible way to achieve compliance with a requirement or test. An asterisk (*) as the first character of a title or at the beginning of a paragraph
41、or table title indicates that there is guidance or rationale related to that item in Annex A. The following paragraph is directed to authorities with jurisdiction and is not intended to address clinical implementation. The attention of Member Bodies and National Committees is drawn to the fact that
42、equipment manufacturers and testing organizations might need a transitional period following publication of a new, amended or revised ISO or IEC publication in which to make products in accordance with the new requirements and to equip themselves for conducting new or revised tests. It is the recomm
43、endation of the committee that the content of this publication be adopted for implementation nationally not earlier than three years from the date of publication for equipment newly designed and not earlier than five years from the date of publication for equipment already in production. This part o
44、f ISO 80369 describes the common TEST METHODS for evaluating the performance requirements of the SMALL-BORE CONNECTORS specified in this series. During the development of the ISO 80369- series, it became evident that many of the TEST METHODS were very similar for each of the APPLICATIONS. It was the
45、refore decided to standardize all the TEST METHODS into a separate part of the series to prevent unnecessary duplication and minor differences. It is also recognized that not all CONNECTORS can be evaluated using each TEST METHOD in this part. The TEST METHODS applicable to each CONNECTOR are specif
46、ied in the respective part of the ISO 80369- series. 2015 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 80369-20:2015 ix x 2015 Association for the Advancement of Medical Instrumentation ANSI/AAMI/ISO 80369-20:2015 American National Standard ANSI/AAMI/ISO 80369-20:2015 Sma
47、ll-bore connectors for liquids and gases in healthcare applications Part 20: Common test methods 1 *Scope This part of ISO 80369 specifies the TEST METHODS to evaluate the performance requirements for SMALL-BORE CONNECTORS specified in the ISO 80369- series. 2 Normative references The following docu
48、ments, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. NOTE 1 The way in which t
49、hese referenced documents are cited in normative requirements determines the extent (in whole or in part) to which they apply. NOTE 2 Informative references are listed in the bibliography. ISO 14971:2007, Medical devices Application of risk management to medical devices ISO 80369-1:2010, Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements 3 Terms and definitions For the purposes of this document, the terms and definitions given in ISO 80369-1:2010, ISO 14971:2007, and the following apply. 3.1 TEST METHOD d
