ANSI ST77-2013 Containment devices for reusable medical device sterilization.pdf

1、ANSI/AAMI ST77:2013Containment devices for reusable medical device sterilizationAmerican 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 unders

2、tood. 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 technologies to patient care, and (2) the encourageme

3、nt 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 and restrictive uses are avoided. A voluntary st

4、andard 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 techniques that can be used to determine whether t

5、he 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, instructions for use, warnings and precautions

6、, 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 facilitate uniformity in reporting; reaching consensus

7、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 establishing the criteria must be documented in the

8、 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 a device is used safely and effectively and tha

9、t 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 recommended practice is usually oriented toward

10、s 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 industrial personnel on such subjects as steriliz

11、ation 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 determining whether an AAMI standard or recommended pr

12、actice 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 procurement authorities). The application of a stan

13、dard 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 representatives, whose work has been reviewed na

14、tionally (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 is limited, however, in the sense that it respo

15、nds 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. Despite periodic review and revision (at least

16、 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 rationale for each of its provisions. This review will

17、 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. While observed or potential risks with existi

18、ng 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 product as “unsafe“. A voluntary standard can

19、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 of the specific needs and resources of the ind

20、ividual 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 it is used in conjunction with other sources o

21、f 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, to the AAMI Vice President, Standards Policy and

22、 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 upon exhaustion of any appeals and upon publicat

23、ion 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 which has not been developed and communicated in

24、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 ST77:2013 (Revision of ANSI/AAMI ST77:2006) Containment devices for reusable medical device sterilization Developed by Association fo

25、r the Advancement of Medical Instrumentation Approved 1 February 2013 by American National Standards Institute Inc. Abstract: This standard covers minimum labeling and performance requirements for rigid sterilization container systems and for instrument organizers. Keywords: containment devices, reu

26、sable rigid sterilization containers, instrument organizers. 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 any respect pre

27、clude 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. CAUTION NOTICE: T

28、his 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 5 years from the date of publication. Interested parties may obtain current information on all AAMI standards by calling or writing AAM

29、I, 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 discretion and professional judgment of the user of the doc

30、ument. 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 Association for the Advancement of Medical Instrumentation 4301 N.

31、Fairfax Dr., Suite 301 Arlington, VA 22203-1633 www.aami.org 2013 by the Association for the Advancement of Medical Instrumentation All Rights Reserved Publication, reproduction, photocopying, storage, or transmission, electronically or otherwise, of all or any part of this document without the prio

32、r written permission of the Association for 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

33、 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 of all or any part of this document, complete the reprint request form at www.aami.org or contac

34、t AAMI, 4301 N. Fairfax Dr., Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 1570204853 Contents Page Glossary of equivalent standards iv Committee representation v Foreword viii Introduction 1 1 Scope 1 1.1 General 1 1.

35、2 Inclusions . 2 1.3 Exclusions 2 2 Normative references 3 3 Definitions and abbreviations 4 4 Requirements 7 4.1 General 7 4.2 Materials of construction 7 4.2.1 Durability . 7 4.2.2 Compatibility with the sterilization process 7 4.2.3 Corrosion resistance 7 4.2.4 Biocompatibility 7 4.3 Design 7 4.3

36、.1 General 7 4.3.2 Decontamination 8 4.3.3 Perforations . 8 4.3.4 Stacking . 8 4.3.5 Maximum weight 9 4.3.6 Additional requirements for reusable rigid sterilization containers . 9 4.4 Performance 11 4.4.1 Sterilization 11 4.4.2 Drying (if applicable) 12 4.4.3 Sterilant residual removal (if applicabl

37、e) 13 4.4.4 Sterility maintenance . 13 4.5 Labeling requirements . 14 4.5.1 Device markings 14 4.5.2 Instructions for use (IFU) . 14 5 Tests . 16 5.1 General 16 5.2 Biocompatibility 16 5.3 Gaskets and filters . 16 5.4 Valves 16 5.5 Handles 16 5.6 Sterilization 16 5.7 Drying (if applicable) 18 5.8 St

38、erilant residual removal (if applicable) 18 5.9 Sterility . 18 5.9.1 Sterility maintenance . 18 Annexes A Medical Device Integration With Rigid Sterilization Container Systems 19 Bibliography . 23 Tables 1 Biological indicators for various sterilization processes 17 A.1 Critical assessment compariso

39、n tool . 20 iv 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST77:2013 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 Internatio

40、nal 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 International Standard. www.aami.org/standards/glossary.pdf 2013 Association for the Advancement of Medical In

41、strumentation ANSI/AAMI ST77:2013 v Committee representation Association for the Advancement of Medical Instrumentation Reusable Sterilization Container Working Group This standard was developed by the AAMI Reusable Sterilization Container Working Group under the auspices of the AAMI Sterilization S

42、tandards Committee. Approval of the standard does not necessarily mean that all working group members voted for its approval. At the time this standard was published, the AAMI Reusable Sterilization Container Working Group had the following members: Co-Chairs: Damien Berg, Medical Center of the Rock

43、ies Joan M. Spear, B Braun of America Inc. Members: Navin Agarwal, Medline Industries Inc. Edward Arscott, 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

44、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; and “can” is used as a statement of possibility and capa

45、bility. “Must” is used only to describe “unavoidable” situations, including those mandated by government regulation. This standard should be considered flexible and dynamic. As technology advances and as new data are brought forward, the standard will be reviewed and, if necessary, revised. Suggesti

46、ons for improving this standard are invited. Comments and suggested revisions should be sent to Technical Programs, AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. NOTEThis foreword does not contain provisions of the American National Standard Containment devices for reusable medic

47、al device sterilization (ANSI/AAMI ST77:2013), but it does provide important information about the development and intended use of the document. 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST77:2013 1 American National Standard ANSI/AAMI ST77:2013 Containment devices fo

48、r reusable medical device sterilization Introduction Containment devices for reusable medical device sterilization comprise a number of different types of systems, including reusable rigid sterilization containers and instrument organizers. Containment devices are intended to serve as packaging for

49、instruments and other medical devices before, during, and after sterilization of the instruments and devices. Furthermore, such systems can be designed as an aid to the efficiency of the surgical procedure. Instrument organizers with lid and base serve to secure and organize instrument sets and other medical devices within a sealed reusable rigid sterilization container or within a legally marketed sterilization wrap. Reusable rigid sterilization containers require a barrier system (e.g., filters or valves) to maintain the integrity of the package. Reusable rigid sterili