AAMI ST108 2023
$172.67
ANSI/AAMI ST108:2023 Water for the processing of medical devices
| Published By | Publication Date | Number of Pages |
| AAMI | 2023 | 102 |
Provides guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI ST108:2023; Water for the processing of medical devices |
| 3 | Title page |
| 4 | AAMI Standard |
| 5 | Copyright information Contents Page |
| 7 | Committee representation |
| 12 | Foreword |
| 13 | Introduction |
| 15 | 1 Scope 1.1 General 1.2 Inclusions 1.3 Exclusions |
| 16 | 2 Normative references 3 Terms and definitions |
| 26 | 4 Roles and responsibilities 4.1 Introduction 4.2 Considerations 4.3 Multidisciplinary team roles |
| 27 | 4.3.1 Executive sponsorship 4.3.2 Facilities engineering personnel 4.3.3 Infection prevention and control personnel |
| 28 | 4.3.4 Medical device processing personnel 4.3.5 Clinical engineering personnel 4.3.6 Surgical suite/procedure areas personnel 4.3.7 Water Treatment Specialist 4.4 Multidisciplinary team responsibilities |
| 29 | Table 1—Multidisciplinary team responsibilities 5 Risk analysis 5.1 Introduction |
| 30 | 5.2 Effects of adverse water quality on medical device processing 5.2.1 General considerations |
| 31 | 6 Categories of water quality for medical device processing 6.1 Introduction 6.2 Three categories of water quality |
| 32 | Table 2—Categories and performance qualification levels of water quality for medical device processing 6.3 Rationale for Table 2 water quality parameters and other considerations: |
| 33 | 6.3.1 Ionic characteristics |
| 34 | 7 Water quality selection and requirements 7.1 Categories of medical devices |
| 35 | 7.2 Stages of medical device processing in which water quality is a consideration |
| 36 | Figure 1—Stages of medical device processing in which water quality is a consideration 7.3 Cleaning 7.3.1 Manual cleaning 7.3.1.1 Point-of-use treatment 7.3.1.2 Cleaning |
| 37 | 7.3.1.3 Rinsing 7.3.1.4 Final Rinsing 7.3.2 Mechanical cleaning by medical washers and medical washer–disinfectors 7.3.2.1 General considerations 7.3.2.2 Water quality factors for medical washers and medical washer–disinfectors |
| 38 | 7.3.2.3 Water quality considerations during cycle stages in a medical washer or medical washer–disinfector 7.3.2.3.1 Initial Rinse 7.3.2.3.2 Wash stage 7.3.2.3.3 Post-wash rinse stage 7.3.2.3.4 Disinfection stage |
| 39 | 7.3.2.3.5 Final rinse stage 7.3.2.3.6 Automated cleaning by ultrasonic cleaners |
| 40 | 7.4 Disinfection 7.4.1 General considerations 7.4.2 Medical devices that are liquid chemical high-level disinfected Table 3—Water quality for processing of devices requiring high-level disinfection 7.4.3 Medical devices that receive pasteurization or thermal disinfection |
| 41 | 7.5 Sterilization 7.5.1 Sterilization processes requiring steam generation 7.5.2 Liquid chemical sterilant 8 Water treatment systems installation and operation qualification 8.1 Introduction 8.2 General issues associated with water treatment |
| 42 | 8.3 Design of water treatment systems 8.3.1 General considerations 8.3.2 General description of Water Treatment System Configurations 8.3.2.1 Water Treatment Systems designed to produce Utility Water 8.3.2.2 Water Treatment Systems designed to produce Critical Water |
| 43 | 8.3.3 Pipework 8.3.4 Treatment system configuration 8.3.4.1 Water distribution and storage |
| 44 | 8.4 Installation and operation qualification requirements 8.4.1 Validation plan |
| 45 | 9 Water treatment systems performance qualification(evaluation of water quality 9.1 General considerations 9.2 Quality characteristics 9.3 Sampling 10 Water treatment systems routine monitoring 10.1 Introduction |
| 46 | 10.2 Goals of water quality monitoring 10.3 Monitoring of water characteristics 10.3.1 General considerations 10.3.2 Water temperature 10.4 Routine water quality sampling |
| 47 | Table 4—Water quality monitoring requirements 11 Continuous quality improvement 11.1 Introduction 11.2 Quality process |
| 48 | Table 5—Frequency for water quality monitoring at water generation system |
| 49 | Table 6—Frequency for water quality monitoring at point-of-water-use |
| 50 | 12 Water treatment systems maintenance 12.1 General considerations 12.2 Serviceability of system |
| 51 | 13 Special considerations 13.1 Post construction or extended shutdown 13.2 Extended boil water alerts and steps to take after alerts are lifted |
| 52 | 13.3 Interruptions in service 13.4 System repair, modification and/or routine maintenance on a Critical Water production, storage, and distribution system 13.4.1 Pretreatment equipment |
| 53 | 13.4.2 Primary treatment equipment 13.4.2.1 Reverse Osmosis (RO) unit 13.4.2.2 Deionization (DI) exchange tanks 13.4.2.3 Electrodeionization (EDI) unit 13.4.3 Storage tanks and distribution equipment and piping |
| 54 | Annex A (informative) Guidance on the application of the normative requirements A.1 Introduction |
| 55 | Table A.1—Water descriptions A.2 General considerations |
| 56 | Table A.2—Water quality for processing devices A.3 Water characteristics |
| 59 | A.3.1 Ionic characteristics A.3.1.1 Corrosive agents |
| 60 | A.3.1.2 Scaling agents |
| 61 | Annex B (informative) Risk analysis B.1 Patient safety Table B.1—Tables of risk factors and effects |
| 62 | B.2 Sterilizer vacuum water supply B.3 Sources of water quality-based risk B.3.1 Utility Water |
| 63 | Table B.2— Impact of water temperature on sterilizer vacuum water supply pump performance B.3.2 Critical Water B.3.3 Bacterial or endotoxin loading B.3.4 Risks to personnel |
| 64 | Table B.3—Work-related risks to staff Annex C (informative) Automated Endoscope Reprocessor (AER) C.1 Automated processing Table C.1—Water quality for LCSPS |
| 66 | Annex D (informative) Water used in cleaning and moist heat processes D.1 Cleaning |
| 67 | D.2 Thermal disinfection D.3 Steam sterilization |
| 70 | Annex E (informative) Water treatment technologies E.1 Introduction E.2 Water treatment technologies |
| 71 | E.2.1 Sediment filters E.2.2 Greensand filters E.2.3 Bag filters E.2.4 Filter cartridges E.2.5 Softeners |
| 72 | E.2.6 Antiscalent E.2.7 pH adjusting chemicals E.2.8 Granular activated carbon adsorption E.2.9 Sulfite salts E.2.10 Reverse osmosis E.2.11 Deionization |
| 73 | E.2.12 Electrodeionization E.2.13 Ultraviolet (UV) disinfection E.2.14 Ultrafiltration E.2.15 Distillation |
| 74 | E.2.16 Ozone disinfection E.2.17 Hot-water disinfection E.2.18 Chemical disinfection |
| 75 | Table E.1—Summary of water treatment methods |
| 77 | Annex F (informative) Water treatment system design F.1 Water treatment system design F.1.1 General design considerations |
| 78 | F.2 Typical water system configurations F.2.1 Water systems designed to produce Utility Water Figure F.1—Example process flow diagram (PFD) F.2.2 Water systems designed to produce Critical Water |
| 79 | F.2.2.1 Primary treatment equipment |
| 80 | F.2.2.2 Storage tanks, distribution equipment, and piping F.2.2.2.1 Storage F.2.2.2.2 Distribution system F.2.2.2.3 Distribution piping |
| 81 | F.2.2.2.4 Distribution pumps F.2.2.2.5 Bacterial and endotoxin controls |
| 82 | F.3 Questions that users should ask when selecting a water treatment system |
| 83 | Annex G (informative) Routine monitoring of water treatment equipment & produced water quality G.1 Overview of monitoring needs G.1.1 Equipment monitoring G.1.2 Monitoring water quality produced G.2 Pretreatment equipment monitoring G.2.1 Sediment filters |
| 84 | G.2.2 Softeners G.2.3 Carbon adsorption |
| 85 | Table G.1—Pretreatment equipment monitoring G.3 Primary treatment equipment monitoring G.3.1 Reverse osmosis (RO) G.3.2 Deionization / electrodeionization G.3.3 Filters / separators |
| 86 | Table G.2—Primary water treatment equipment monitoring G.4 Storage tanks, distribution equipment, and piping monitoring G.4.1 Water storage tanks G.4.2 Distribution pumps G.4.3 Ultraviolet irradiators G.4.4 Ultrafiltration G.4.5 Final cartridge filtration |
| 87 | G.4.6 Water distribution systems G.5 Bacterial control equipment G.5.1 Ozone generators G.5.2 Hot water disinfection systems |
| 88 | Table G.3—Storage and Distribution Equipment Monitoring |
| 89 | Annex H (informative) Maintaining microbiological quality H.1 Introduction H.2 General considerations |
| 90 | H.3 Microbiological quality – bioburden by colony forming unit (CFU) H.3.1 Heterotrophic plate count |
| 91 | H.3.1.1 Membrane-filtration method H.3.1.2 Spread-plate method H.3.1.3 Pour-plate method H.4 Microbiological quality – bacterial endotoxin test H.4.1 Limulus amebocyte lysate (LAL) |
| 92 | H.5 How to perform water sampling H.5.1 Sample collection H.5.2 Water sampling technique H.6 Results exceeding specification |
| 94 | Annex I (informative) Typical presentation of water quality issues during the processing of medical devices Table I.1—Examples of observed problems during medical device processing that can be caused by poor water quality |
| 97 | Bibliography |
