ANSI ST8-2013 Hospital steam sterilizers (FDA RECOGNIZED).pdf

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1、ANSI/AAMIST8:2013Hospital 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 technic

2、al 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 AAMIs v

3、iew 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 recommend

4、s 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 an

5、d 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 important

6、 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 consid

7、erable 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 pr

8、ovides 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 maintained.

9、 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 be

10、 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 collecti

11、ng 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 ne

12、eds 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 solel

13、y 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 international

14、ly). 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 and

15、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 standard o

16、r 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 remains

17、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 basis

18、 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 ulti

19、mate 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, t

20、he 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 and

21、 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 interpretation

22、 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 th

23、e “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 wh

24、ich is not published, by appropriate notice, as an official interpretation in the AAMI News. American National Standard ANSI/AAMI ST8:2013 (Revision of ANSI/AAMI ST8:2008) Hospital steam sterilizers Developed by Association for the Advancement of Medical Instrumentation Approved 25 April 2013 by Ame

25、rican National Standards Institute Inc. Abstract: This standard covers minimum construction and performance requirements for hospital sterilizers that use saturated steam as the sterilizing agent and have a volume greater than 56.63 liters (2 cubic feet). Keywords: moist heat sterilization, saturate

26、d steam, steam quality, 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 any respect preclude anyone, whe

27、ther 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: This AAMI standard

28、 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 AAMI, or by visiting

29、 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 document. Occasional

30、ly, 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. Fairfax Dr., Suit

31、e 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 prior written permiss

32、ion 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 the Association

33、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 contact AAMI, 4301 N. F

34、airfax 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 157020493-4 Contents Page Glossary of equivalent standards . v Committee representation . vi Foreword vii 1 Scope . 1 1.1 General 1 1.2 Inclusions . 1 1.3 Exclu

35、sions 1 2 Normative references 1 3 Definitions, symbols, and abbreviations . 2 4 Requirements 5 4.1 Labeling . 5 4.1.1 Device markings 5 4.1.2 Information manual 5 4.1.3 Service manual 6 4.2 Sterilizer design, construction, components, and accessories 6 4.2.1 Pressure requirements 6 4.2.2 Pressure v

36、essel certification 6 4.2.3 Electrical components . 6 4.2.4 Corrosion resistance . 6 4.2.5 Air filters 6 4.3 Sterilizer safety 6 4.3.1 Interlock . 6 4.3.2 Prevention of thermal hazards 6 4.3.3 Sterilizer controls for aborting cycles . 7 4.4 Process monitoring and control devices 7 4.4.1 General 7 4.

37、4.2 Chamber temperature . 7 4.4.3 Thermometric test connection . 8 4.4.4 Sterilizer exposure timer 8 4.4.5 Pressure measurement . 8 4.4.6 Cycle documentation . 8 4.5 Biological performance of sterilizers 8 4.6 Mechanical air removal 9 4.6.1 Air removal (dynamic-air-removal sterilizers) 9 4.6.2 Air l

38、eaks (prevacuum sterilizers) . 9 4.7 Moisture retention 9 4.8 Sterilizer performance certification and record-keeping 9 5 Tests 10 5.1 Labeling . 10 5.2 Sterilizer design, construction, components, and accessories 10 5.2.1 Pressure requirements 10 5.2.2 Pressure vessel certification 10 5.2.3 Electri

39、cal components . 10 5.2.4 Corrosion resistance . 10 5.2.5 Air filters 10 5.3 Sterilizer safety 10 5.3.1 Interlock . 10 5.3.2 Prevention of thermal hazards 10 5.3.3 Sterilizer controls for aborting cycles . 11 5.4 Process monitoring and control devices 11 5.4.1 General 11 5.4.2 Chamber temperature .

40、11 5.4.3 Thermometric test connection . 11 5.4.4 Sterilizer exposure timer 11 5.4.5 Pressure indicators 11 5.4.6 Cycle documentation . 11 5.5 Biological performance of sterilizers 12 5.5.1 General testing requirements 12 5.5.2 Biological performance with a fabric PCD . 12 5.5.3 Biological performanc

41、e with liquid loads (if applicable) . 14 5.5.4 Biological performance with wrapped instrument PCD . 15 5.5.5 Biological performance of immediate-use steam sterilization for single-wrapped or unwrapped nonporous items . 17 5.6 Mechanical air removal tests . 18 5.6.1 Air removal test (dynamic-air-remo

42、val sterilizers) . 18 5.6.2 Air leak-rate test (prevacuum sterilizers) . 22 5.7 Moisture retention tests 22 5.7.1 Moisture retention with a fabric PCD 22 5.7.2 Moisture retention with a wrapped instrument PCD 23 Annexes A Rationale for the development and provisions of this standard 24 B Examples of

43、 cycle documentation 28 C Bibliography 33 Table 1 Conversions of saturated pressure units at sea level . 4 Figures 1 Preparation of the fabric (16-towel) PCD 13 2 Placement of fabric (16-towel) PCD for qualification testing of gravity-displacement steam sterilizers 13 3 Surgical instrument tray to b

44、e used in the wrapped instrument PCD (the cotton lining is removed to show the perforated bottom) . 16 4 Surgical instrument tray (25 cm by 51 cm 10 inches by 20 inches and wrapper (137 cm by 137 cm 54 inches by 54 inches) for use in the wrapped instrument PCD . 16 5 Composition of the Bowie-Dick te

45、st pack . 19 6 Placement of the Bowie-Dick test pack 20 7 Time-temperature profile of temperature sensor T1 . 21 B.1 Schematic of a gravity-displacement cycle . 28 B.2 Schematic of a dynamic-air-removal cycle . 29 B.3 Example of a cycle printout . 30 B.4 Example of a cycle printout . 31 B.5 Example

46、of cycle printout information . 32 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI ST8:2013 v Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. AAMI maintains a current li

47、st 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 International Standard. www.aami.org/standards/glossary.pdf vi 2013 Association for the A

48、dvancement of Medical Instrumentation ANSI/AAMI ST8:2013 Committee representation Association for the Advancement of Medical Instrumentation Hospital Steam Sterilizer Working Group This standard was developed by the AAMI Hospital Steam Sterilizer Working Group under the auspices of the AAMI Steriliz

49、ation Standards Committee. Approval of the standard does not necessarily mean that all working group members voted for its approval. At this time this document was published, the AAMI Hospital Steam Sterilizer Working Group had the following members: Cochairs: Rose E. Seavey, RN MBA CNO.R CRCST Mark N. Smith Members: Nola Bayes, MBA, Sanford Health Gary Wayne Benning, Midmark Corporation Mark Chiffon, STERIS Corporation Nancy Chobin, RN CSPDM, St Barnabas Healthcare System John T. Collins, MSEE, American Society for Healthcare Engineering Ramona Conner, RN MS