1、ANSI/AAMI ST55:2016Table-top steam sterilizersAmerican 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 clearly understood. The objectives of AAMIs tech
2、nical 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 encouragement of new technologies. It is AAMI
3、s 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 voluntary standard for a medical device recomm
4、ends 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 determine whether the device conforms with the safety
5、 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 precautions, and other data considered import
6、ant 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 consensus on these tests can represent a con
7、siderable 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 documented in the rationale. A recommended practice
8、 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 effectively and that its performance will be maintain
9、ed. 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 oriented towards healthcare professionals, it may
10、 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 as sterilization processing, methods of colle
11、cting 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 recommended practice is relevant to the specific
12、 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 application of a standard or recommended practice is so
13、lely 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 reviewed nationally (and sometimes internatio
14、nally). 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 that it responds generally to perceived risks a
15、nd 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 revision (at least once every five years), a standar
16、d 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 review will reveal whether the document remai
17、ns 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 with existing equipment typically form the ba
18、sis 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 standard can be used as one resource, but the u
19、ltimate 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 of the individual institution or firm. Again
20、, 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 other sources of information and policy guidance
21、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 Policy and Programs. An official interpretat
22、ion 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 upon publication of notice of interpretation in
23、 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 communicated in accordance with this procedure and
24、 which is not published, by appropriate notice, as an official interpretation in the AAMI News. American National Standard ANSI/AAMI ST55:2016 (Revision of ANSI/AAMI ST55:2010/(R)2014) Table-top steam sterilizers Approved 7 October 2016 by AAMI Approved 1 November 2016 by American National Standards
25、 Institute, Inc. Abstract: This standard establishes minimum construction and performance requirements for small table-top steam sterilizers that use saturated steam as the sterilizing agent and that have a volume less than or equal to 56.63 liters (2 cubic feet). Keywords: distilled water, moist he
26、at sterilization, process monitoring, saturated steam, steam sterilization 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 existence of an AAMI standard does not in a
27、ny 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 cautioned to obtain the latest editions. CAU
28、TION 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 information on all AAMI standards by calli
29、ng or writing AAMI. 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 discretion and professional judgment of the user of the document. Occasionally, voluntary t
30、echnical 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 AAMI 4301 N Fairfax Drive, Suite 301 Arlington, VA 22203-1633 2017 by the Association for the Advan
31、cement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of AAMI. Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part of this document without the prior written permission of the Association f
32、or the Advancement of Medical Instrumentation is strictly prohibited by law. 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 M
33、edical 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 of this document, complete the reprint request form at www.aami.org or contact AAMI at 4301 N Fairfax Drive, Suite 301
34、, Arlington, VA 22203-1633. Phone: (703) 525-4890; Fax: (703) 276-0793. Printed in the United States of America ISBN 978-1-57020-626-9Contents Page Glossary of equivalent standards iv Committee representation . vForeword . vii1 Scope . 11.1 General 11.2 Inclusions . 11.3 Exclusions 12 Normative refe
35、rences . 13 Definitions, symbols, and abbreviations 24 Requirements 34.1 Labeling 34.2 Sterilizer design, construction, components, and accessories . 54.3 Sterilizer safety . 5 4.4 Process monitoring and control devices . 64.5 Biological performance of sterilizers . 84.6 Mechanical air removal 84.7
36、Moisture retention 84.8 Sterilizer performance certification and recordkeeping . 85 Tests 85.1 Labeling 95.2 Sterilizer design, construction, components, and accessories . 95.3 Sterilizer safety . 95.4 Process monitoring and control devices . 95.5 Biological performance of sterilizers . 105.6 Mechan
37、ical air removal 175.7 Moisture retention 185.8 Sterilizer performance certification and recordkeeping . 20Annex A Rationale for the development and provisions of this standard 21Annex B Examples of temperature during the holding time 26 Annex C Examples of cycle documentation 29 Bibliography . 31 i
38、v 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST55:2016 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
39、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 International Standard. www.aami.org/standards/glossary.pdf 2017 Association for the Advancement of Medical Instrumentation
40、 ANSI/AAMI ST55:2016 v Committee representation Association for the Advancement of Medical Instrumentation AAMI Hospital Steam Sterilizer Working Group This standard was developed by the AAMI Hospital Steam Sterilizer Working Group under the auspices of the AAMI Sterilization Standards Committee. Ap
41、proval of this standard does not necessarily mean that all working group members voted for its approval. At the time this document was published, the AAMI Hospital Steam Sterilizer Working Group had the following members: Cochairs: Members:Alternates: Susan G. Klacik, CCSMC FCS ACE, International As
42、sociation of Healthcare Central Service Materiel Management Jonathan A. Wilder, PhD, Quality Processing Resource Group LLC Mohamed Ali, Medline Industries Inc Michael Bacik, STERIS Corporation Nola Bayes, MBA, Sanford Health Gary Benning, Midmark Corporation Nancy Chobin, RN, CSPDM, CFER, Sterile Pr
43、ocessing University LLC Fiona Collins, American Dental Association John Collins, American Hospital Association Michael DOnofrio, Presage Health Marcia Ann Frieze, Case Medical Inc Nelson Garrido, Belimed Inc Russell Gilbert, Cox Health Systems Joel R. Gorski, PhD, NAMSA Jason Harrington, VA Medical
44、Center of Cincinnati Nupur Jain, Intuitive Surgical Inc Scott Jelley, Johnson “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
45、 (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; and “can” is used as a statement of possibility and capability. “Must” is used only to descri
46、be “unavoidable” situations, including those mandated by government regulation. This standard should be considered flexible and dynamic. AAMI and ANSI procedures require that standards be reviewed every five years and, if necessary, revised to reflect technological advances that may have occurred si
47、nce publication. Suggestions for improving this standard are invited. Comments and suggested revisions should be sent to Technical Programs, AAMI, 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633. NOTEThis foreword does not contain provisions of the American National Standard, Table-top stea
48、m sterilizers (ANSI/AAMI ST55:2016), but it does provide important information about the development and intended use of the document. viii 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST55:2016 2017 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST
49、55:2016 1 American National Standard ANSI/AAMI ST55:2016 Table-top steam sterilizers 1 Scope 1.1 General This standard applies to steam sterilizers that are intended for use in health care facilities and that have a volume less than or equal to 56.63 liters (2 cubic feet ft3). NOTEFor purposes of this standard, health care facilities refers to hospitals, nursing homes, extended-care facilities, freestanding surgical centers, clinics, and medical and dental offices. For convenience, the term hospital is sometimes used in this standard; in all instances, this term sho
