ANSI ST50-2004 Dry heat (heated air) sterilizers (FDA RECOGNIZED).pdf

1、Association for the Advancementof Medical InstrumentationANSI/AAMI ST50:2004/(R)2010Dry heat (heated air) sterilizersThe Objectives and Uses of AAMI Standards andRecommended PracticesIt is most important that the objectives and potential uses of an AAMIproduct standard or recommended practice are cl

2、early understood.The objectives of AAMIs technical development program derivefrom AAMIs overall mission: the advancement of medicalinstrumentation. Essential to such advancement are (1) a continuedincrease in the safe and effective application of current technologiesto patient care, and (2) the enco

3、uragement of new technologies. It isAAMIs view that standards and recommended practices cancontribute significantly to the advancement of medicalinstrumentation, provided that they are drafted with attention to theseobjectives and provided that arbitrary and restrictive uses are avoided.A voluntary

4、standard for a medical device recommends to themanufacturer the information that should be provided with or on theproduct, basic safety and performance criteria that should be con-sidered in qualifying the device for clinical use, and the measurementtechniques that can be used to determine whether t

5、he device conformswith the safety and performance criteria and/or to compare the per-formance characteristics of different products. Some standards em-phasize the information that should be provided with the device,including performance characteristics, instructions for use, warningsand precautions,

6、 and other data considered important in ensuring thesafe and effective use of the device in the clinical environment.Recommending the disclosure of performance characteristics oftennecessitates the development of specialized test methods to facilitateuniformity in reporting; reaching consensus on th

7、ese tests canrepresent a considerable part of committee work. When a draftingcommittee determines that clinical concerns warrant the establishmentof minimum safety and performance criteria, referee tests must beprovided and the reasons for establishing the criteria must bedocumented in the rationale

8、A recommended practice provides guidelines for the use, care,and/or processing of a medical device or system. A recommendedpractice does not address device performance per se, but ratherprocedures and practices that will help ensure that a device is usedsafely and effectively and that its performan

9、ce will be maintained.Although a device standard is primarily directed to the manufac-turer, it may also be of value to the potential purchaser or user of thedevice as a fume of reference for device evaluation. Similarly, eventhough a recommended practice is usually oriented towards healthcare profe

10、ssionals, it may be useful to the manufacturer in betterunderstanding the environment in which a medical device will beused. Also, some recommended practices, while not addressing deviceperformance criteria, provide guidelines to industrial personnel onsuch subjects as sterilization processing, meth

11、ods of collecting data toestablish safety and efficacy, human engineering, and otherprocessing or evaluation techniques; such guidelines may be useful tohealth care professionals in understanding industrial practices.In determining whether an AAMI standard or recommendedpractice is relevant to the s

12、pecific needs of a potential user of thedocument, several important concepts must be recognized:All AAMI standards and recommended practices are voluntary(unless, of course, they are adopted by government regulatory orprocurement authorities). The application of a standard or recom-mended practice i

13、s solely within the discretion and professionaljudgment of the user of the document.Each AAMI standard or recommended practice reflects thecollective expertise of a committee of health care professionals andindustrial representatives, whose work has been reviewed nationally(and sometimes internation

14、ally). As such, the consensusrecommendations embodied in a standard or recommended practiceare intended to respond to clinical needs and, ultimately, to helpensure patient safety. A standard or recommended practice is limited,however, in the sense that it responds generally to perceived risks andcon

15、ditions that may not always be relevant to specific situations. Astandard or recommended practice is an important reference inresponsible decision-making, but it should never replace responsibledecisionmaking.Despite periodic review and revision (at least once every fiveyears), a standard or recomme

16、nded practice is necessarily a staticdocument applied to a dynamic technology. Therefore, a standardsuser must carefully review the reasons why the document wasinitially developed and the specific rationale for each of itsprovisions. This review will reveal whether the document remainsrelevant to th

17、e specific needs of the user.Particular care should be taken in applying a product standard toexisting devices and equipment, and in applying a recommendedpractice to current procedures and practices. While observed orpotential risks with existing equipment typically form the basis for thesafety and

18、 performance criteria defined in a standard, professionaljudgment must be used in applying these criteria to existing equip-ment. No single source of information will serve to identify aparticular product as “unsafe“. A voluntary standard can be used asone resource, but the ultimate decision as to p

19、roduct safety andefficacy must take into account the specifics of its utilization and, ofcourse, cost-benefit considerations. Similarly, a recommendedpractice should be analyzed in the context of the specific needs andresources of the individual institution or firm. Again, the rationaleaccompanying

20、each AAMI standard and recommended practice is anexcellent guide to the reasoning and data underlying its provision.In summary, a standard or recommended practice is truly usefulonly when it is used in conjunction with other sources of informationand policy guidance and in the context of professiona

21、l experience andjudgment.INTERPRETATIONS OF AAMI STANDARDSAND RECOMMENDED PRACTICESRequests for interpretations of AAMI standards and recommendedpractices must be made in writing, to the Manager for TechnicalDevelopment. An official interpretation must be approved by letterballot of the originating

22、committee and subsequently reviewed andapproved by the AAMI Standards Board. The interpretation willbecome official and representation of the Association only uponexhaustion of any appeals and upon publication of notice of interpre-tation in the “Standards Monitor“ section of the AAMI News. TheAssoc

23、iation for the Advancement of Medical Instrumentationdisclaims responsibility for any characterization or explanation of astandard or recommended practice which has not been developed andcommunicated in accordance with this procedure and which is notpublished, by appropriate notice, as an official i

24、nterpretation in theAAMI News.American National Standard ANSI/AAMI ST50:2004/(R)2010 (Revision of ANSI/AAMI ST50:1995) Dry heat (heated air) sterilizers Developed by Association for the Advancement of Medical Instrumentation Approved 7 April 2004 and reaffirmed 24 March 2010 by American National Sta

25、ndards Institute, Inc. Abstract: This standard establishes minimum labeling and performance requirements for dry heat (heated air) sterilizers intended for use in dental and medical offices, laboratories, ambulatory-care clinics, hospitals, and other health care facilities. Keywords: dry heat steril

26、ization 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, whether they have approved the standard

27、 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 may be revised or withdrawn at any

28、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 and recommended practices by calling or writing AAMI. All AAMI standards, r

29、ecommended 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 technical documents are adopted by governm

30、ent 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 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 2004 by the Association fo

31、r 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 permission of the Association for the Advancement of Medical Instrumentation

32、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 Medical Instrumentation. Violators risk legal a

33、ction, 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, contact AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067. Printed in the United States of

34、 America ISBN 1570202133 Contents Page Glossary of equivalent standards .v Committee representation vii Acknowledgment. viii Foreword.ix 1 Scope1 1.1 General 1 1.2 Inclusions .1 1.3 Exclusions1 2 Normative references1 3 Definitions of terms .1 4 Requirements3 4.1 Labeling3 4.1.1 Device markings 3 4.

35、1.2 Information manual 3 4.1.3 Service manual 4 4.2 Electrical components 4 4.3 Loading accessories 4 4.4 Prevention of thermal hazards .4 4.5 Sterilizer controls for aborting cycles4 4.6 Process control and monitoring devices.4 4.6.1 Chamber temperature4 4.6.2 Sterilizer exposure timer 5 4.6.3 Airf

36、low5 4.6.4 Cooling.5 4.7 Biological performance of sterilizers.5 4.8 Certification and record-keeping 5 4.9 Software quality assurance 5 4.9.1 Software developed in-house.5 4.9.2 Custom-developed software 5 4.9.3 Off-the-shelf software.6 5 Tests .6 5.1 Labeling6 5.2 Electrical components 6 5.3 Loadi

37、ng accessories 6 5.4 Prevention of thermal hazards .6 5.5 Sterilizer controls for aborting cycles6 5.6 Process control and monitoring devices.6 5.6.1 Chamber temperature6 5.6.2 Sterilizer exposure timer 7 5.6.3 Airflow7 5.6.4 Cooling.7 5.7 Biological performance of sterilizers.7 5.7.1 General consid

38、erations 7 5.7.2 Biological-indicator challenge test pack .7 5.7.3 Simulated-use tests .8 5.8 Certification and record-keeping 8 5.9 Software quality assurance 8 Annexes A Rationale for the development and provisions of this standard.9 B Example of a biological-indicator challenge test pack for dry

39、heat sterilizers 15 C Bibliography 28 Tables B.1 Temperature profile for Sterilizer A (1 hour cycle) .16 B.2 Temperature profile for Sterilizer A (30 minute cycle)16 B.3 BI and CI results for Sterilizer A 17 B.4 BI and CI results for Sterilizer B 19 B.5 Temperature profile for Sterilizer C (half-cyc

40、le) .20 B.6 BI and CI results for Sterilizer C 22 B.7 Temperature profile for Sterilizer D (test #1) .24 B.8 Temperature profile for Sterilizer D (test #2) .24 B.9 Temperature profile for Sterilizer D (test #3) .25 B.10 BI and CI results for Sterilizer D 25 Figures A.1 Batch cycle: Convective dry he

41、at (static air)10 A.2 Batch cycle: Convective dry heat (forced air) with chamber heat continuously maintained .11 A.3 Batch cycle: Convective dry heat (forced air); load remains in chamber during cool-down .11 B.1 Load configuration for Sterilizer A16 B.2 Load configuration for Sterilizer B17 B.3 Te

42、mperature profile for BI challenge test pack and instrument rack for Sterilizer B (12 minute cycle) .18 B.4 Temperature profile for BI challenge test pack and instrument rack for Sterilizer B (6 minute cycle) .18 B.5 Load configuration for Sterilizer C .20 B.6 Temperature profile for Sterilizer C (h

43、alf-cycle) .21 B.7 Temperature profile for Sterilizer C (standard cycle) .22 B.8 Load configuration for Sterilizer D (test #1) .23 B.9 Load configuration for Sterilizer D (test #2) .23 B.10 Load configuration for Sterilizer D (test #3) .24 B.11 Temperature profile for Sterilizer D (46 minute cycle)

44、25 B.12 Temperature profile for Sterilizer D (18 minute cycle) .26 B.13 Temperature profile for Sterilizer D (16.5 minute cycle) 27 2004 Association for the Advancement of Medical Instrumentation ! ANSI/AAMI ST50:2004 v Glossary of equivalent standards International Standards adopted in the United

45、States may include normative references to other International Standards. For each International Standard that has been adopted by AAMI (and ANSI), the table below gives the corresponding U.S. designation and level of equivalency to the International Standard. NOTEDocuments are sorted by internation

46、al designation. Other normatively referenced International Standards may be under consideration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. International designation U.S. designation Equivalency IEC 60601-1-2:2001 ANSI/AAMI/IEC 60601-1-2:2001 Identical IEC 60

47、601-2-04:2002 ANSI/AAMI DF80:2003 Major technical variations IEC 60601-2-21:1994 and Amendment 1:1996 ANSI/AAMI/IEC 60601-2-21 “should” indicates that among several possibilities one is recommended as particularly suitable, without mentioning or excluding others, or that a certain course of action i

48、s preferred 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 recommended practice; and “can” is used as a statement

49、 of possibility and capability. “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 new data is brought forward, the standard will be reviewed and, if necessary, revised. AAMI policies and procedures require that AAMI standards and recommended practices be reviewed and, if necessary, revised at least once every 5 years. Suggestions for improving this standard are invited. Comments and suggested revisions should be sent to Technical Programs,