ANSI ST79-2017 Comprehensive guide to steam sterilization and sterility assurance in health care facilities.pdf

1、www.aami.orgANSI/AAMI ST79: 2017American National StandardANSI/AAMI ST79:2017Comprehensive guide to steam sterilization and sterility assurance in health care facilitiesObjectives and uses of AAMI standards and recommended practices It is most important that the objectives and potential uses of an A

2、AMI product standard 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 o

3、f current technologies 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

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8、reasons for establishing 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 h

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24、nded practice which 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 ST79:2017 (Revision of ANSI/AAMI ST79:2010/(R)2014 staff qualification

25、s, education, and other personnel considerations; processing procedures; installation, care, and maintenance of steam sterilizers; quality control; and quality process improvement. Keywords: ambulatory care facilities, cleaning, continuous quality improvement, decontamination, dentaloffice, immediat

26、e-use steam sterilization (IUSS), moist heat sterilization, packaging, quality control, quality system, saturated steam, sterile storage, sterilization containers, surgical instruments, table-top sterilizers AAMI Single user license. Further copying, networking, and distribution prohibited. AAMI Rec

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35、+1-703-525-4890; Fax: +1-703-525-1067. With the permission of Canadian Standards Association, (operating as CSA Group), material is reproduced from CSA Group standard Z314.8-00, Decontamination of reusable medical devices which is copyrighted by Canadian Standards Association, 178 Rexdale Blvd., Tor

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37、or for any interpretations thereof. No further reproduction is permitted. For more information or to purchase standards from CSA Group, please visit http:/shop.csa.ca/ or call 1-800-463-6727. Printed in the United States of America ISBN 978-1-57020-675-7 AAMI Single user license. Further copying, ne

38、tworking, and distribution prohibited. Contents PageGlossary of equivalent standards ix Committee representation xii Foreword xv Introduction: Need for the recommended practice . 1 1 Scope. 3 1.1 General . 3 1.2 Inclusions 3 1.3 Exclusions 3 2 Definitions and abbreviations . 4 3 Design consideration

39、s 12 3.1 General considerations . 12 3.2 Work area design and functional workflow . 12 3.2.1 Design criteria 12 3.2.2 Functional workflow patterns . 14 3.2.3 Traffic control . 15 3.3 Utilities 17 3.3.1 Mechanical systems 17 3.3.2 Electrical systems 17 3.3.3 Steam for sterile processing 17 3.3.4 Util

40、ity monitoring and alarm systems . 18 3.3.5 General facility design requirements . 18 3.3.6 Special area requirements and restrictions . 21 3.3.7 Emergency eyewash/shower equipment . 24 4 Personnel considerations . 25 4.1 General considerations . 25 4.2 Qualifications 25 4.2.1 Supervisory personnel

41、. 25 4.2.2 Sterile processing personnel . 25 4.3 Education and training 26 4.3.1 Sterile processing personnel . 26 4.3.2 Service personnel 26 4.3.3 Other personnel . 27 4.4 Health and personal hygiene 27 4.5 Attire . 27 4.5.1 General considerations 27 4.5.2 Decontamination area/room 28 4.6 Standard

42、and transmission-based precautions . 29 5 Receiving . 30 5.1 General considerations . 30 5.2 Receiving of purchased or loaned items . 30 5.2.1 General considerations 30 5.2.2 New, repaired, and refurbished reusable items . 30 5.2.3 Loaned or borrowed instrumentation . 30 5.2.4 Rigid sterilization co

43、ntainer systems 31 5.2.5 Disposable items . 32 5.3 Disposition of sterile items (issued but not used) 32 6 Handling, collection, and transport of contaminated items . 33 6.1 General considerations . 33 6.2 Separation of waste and reusable items at point of use . 33 6.3 Point-of-use care and handling

44、 of contaminated reusable items 34 6.4 Containment . 35 6.5 Transport 36 AAMI Single user license. Further copying, networking, and distribution prohibited. 6.5.1 Segregation of clean/sterile items 36 6.5.2 Transportation scheduling and routes . 36 6.5.3 Transportation equipment 36 6.5.4 Hand transp

45、ort . 36 6.5.5 Dedicated lifts 37 6.5.6 Transport between buildings 37 6.5.7 Off-site transportation 37 7 Cleaning, disinfection (microbicidal processes), and other decontamination steps . 39 7.1 General considerations . 39 7.2 Policies and procedures . 39 7.3 Manufacturers written IFU 40 7.4 Decont

46、amination . 40 7.4.1 General considerations for all devices and utensils . 40 7.4.2 Special considerations . 41 7.5 Preparation for cleaning 41 7.5.1 Presoaking. 41 7.5.2 Sorting and disassembly . 41 7.6 Cleaning . 43 7.6.1 General considerations 43 7.6.2 Devices with lumens 44 7.6.3 Cleaning agents

47、 . 44 7.6.4 Methods of cleaning 44 8 Preparation and assembly of instruments 50 8.1 General considerations . 50 8.2 Instruments . 50 8.3 Devices with lumens . 51 8.4 Basins and basin sets . 51 8.5 Textile packs . 51 9 Packaging 52 9.1 General considerations . 52 9.2 Selection of sterile barrier syst

48、ems . 52 9.3 Package labeling 52 9.4 Package closures . 53 9.5 Sterilization wrap 53 9.5.1 General considerations 53 9.5.2 Woven wraps . 53 9.5.3 Nonwoven wraps . 53 9.5.4 Paperplastic pouches 54 9.6 Wrapping techniques 55 9.6.1 Simultaneous double-wrapping: envelope fold 55 9.6.2 Simultaneous doubl

49、e-wrapping: square fold 56 9.6.3 Sequential wrapping: envelope fold . 57 9.6.4 Sequential wrapping: square fold 58 9.7 Sterility maintenance covers . 59 9.8 Rigid sterilization container systems . 59 10 Sterilization 61 10.1 Loading the sterilizer . 61 10.1.1 General considerations 61 10.1.2 Paperplastic pouches 61 10.1.3 Instrument sets 61 10.1.4 Textile packs 61 10.1.5 Utensils and glassware 61 10.1.6 Rigid sterilization container systems 62 10.1.7 Liquids . 62 10.1.8 Powders and oils . 63 10.2 Sterilization parameters 63 10.2.1 General considerations 63 10.2.2 Sterilization cycle