AAMI TIR34 2014 RA 2017
$140.32
AAMI TIR34: 2014/(R)2017 – Water for the reprocessing of medical devices
| Published By | Publication Date | Number of Pages |
| AAMI | 2014 | 76 |
This technical information report (TIR) covers the selection and maintenance of effective water quality suitable for reprocessing medical devices. It provides guidelines for selecting the water quality necessary for the reprocessing of categories of medical devices and addresses water treatment equipment, water distribution and storage, quality control procedures for monitoring water quality, strategies for bacterial control, and environmental and personnel considerations.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | AAMI TIR34:2014/(R)2017, Water for the reprocessing of medical devices |
| 3 | Title page |
| 4 | AAMI Technical Information Report Copyright information |
| 5 | Contents Page |
| 7 | Glossary of equivalent standards |
| 8 | Committee representation |
| 10 | Foreword |
| 11 | Introduction |
| 12 | 1. Scope 1.1 General 1.2 Inclusions 1.3 Exclusions 2. Definitions and abbreviations |
| 18 | 3. The importance of water quality and effective water treatment 3.1 Introduction 3.2 Major impacts of adverse water quality on medical device reprocessing 3.2.1 General considerations 3.2.2 Microbial level in water |
| 19 | 3.2.3 Inorganic and organic components of water 3.2.3.1 General considerations 3.2.3.2 Bacterial endotoxins 3.2.3.3 Total organic carbon |
| 20 | 3.2.3.4 pH 3.2.3.5 Water hardness 3.2.3.6 Ionic contaminants and resistivity 3.2.4 Water temperature 3.3 Treatment of water 3.3.1 General considerations |
| 21 | 3.3.2 Pretreatment 3.3.3 Principal water treatment processes |
| 22 | 3.3.3.1 Deionization 3.3.3.2 Reverse osmosis 3.3.3.3 Distillation 3.3.4 Distribution 3.4 Categories of medical devices |
| 23 | 3.5 Stages of medical device reprocessing in which water quality is a consideration |
| 25 | 4. Categories of water quality for medical device reprocessing 4.1 Introduction 4.2 Two categories of water quality |
| 28 | 5. Selection of water quality 5.1 Introduction 5.2 Cleaning 5.2.1 Manual cleaning 5.2.1.1 Precleaning and rinsing 5.2.1.2 Cleaning 5.2.1.3 Rinsing 5.2.2 Mechanical cleaning by medical washers and medical washer–disinfectors 5.2.2.1 General considerations |
| 29 | 5.2.2.2 Water quality factors for medical washers and medical washer–disinfectors 5.2.2.3 Water quality considerations during cycle stages in a medical washer or medical washer–disinfector 5.2.2.3.1 Enzymatic prewash stage 5.2.2.3.2 Wash stage |
| 30 | 5.2.2.3.3 Disinfection stage 5.2.2.3.4 Rinse stages 5.2.3 Automated cleaning by ultrasonic cleaners 5.3 Disinfection and sterilization 5.3.1 General considerations |
| 31 | 5.3.2 Medical devices that receive steam sterilization or low-temperature gas sterilization |
| 33 | 5.3.3 Medical devices that receive liquid chemical high-level disinfection |
| 35 | 5.3.4 Medical devices that receive liquid chemical sterilization |
| 37 | 5.3.5 Medical devices that receive pasteurization or thermal disinfection |
| 38 | 6 Water treatment systems 6.1 Introduction 6.2 General issues associated with water treatment |
| 39 | 6.3 Design of water treatment systems 6.3.1 General considerations 6.3.2 Physical layout of the water purification, distribution, and storage system 6.3.2.1 Water treatment |
| 40 | 6.3.2.2 Water distribution and storage 7 Monitoring water quality 7.1 Introduction 7.2 Goals of water quality monitoring 7.3 Water characteristics that should be monitored 7.3.1 General considerations 7.3.2 Water temperature |
| 43 | 8 Strategies for bacterial control 9 Personnel considerations 9.1 Introduction 9.2 Device reprocessing personnel 9.3 Water maintenance personnel 9.4 Audits 10 Continuous quality improvement 10.1 Introduction 10.2 Quality process |
| 45 | Annex A: Water treatment methods A.1 Introduction A.2 Water treatment equipment A.2.1 General considerations A.2.2 Sediment filters |
| 46 | A.2.3 Filter cartridges A.2.4 Softeners A.2.5 Carbon adsorption A.2.6 Reverse osmosis |
| 47 | A.2.7 Deionization A.2.8 Ultrafiltration |
| 48 | A.2.9 Distillation A.3 Water treatment options |
| 53 | A.4 Questions that users should ask when selecting a water treatment system A.5 Validation of a water treatment system A.5.1 General considerations A.5.2 Validation plan |
| 54 | A.5.3 Quality characteristics A.5.4 Sampling |
| 55 | Annex B: Monitoring water treatment equipment and processes B.1 Introduction B.2 Overview of monitoring needs B.3 Monitoring microbial levels in rinse water B.4 Sediment filters |
| 57 | B.5 Filter cartridges B.6 Softeners |
| 58 | B.7 Carbon adsorption B.8 Reverse osmosis |
| 59 | B.9 Deionization B.10 Ultrafiltration B.11 Distillation B.12 Water distribution and storage B.12.1 Water storage tanks B.12.2 Water distribution systems B.13 Bacterial control equipment |
| 60 | B.13.1 Ultraviolet irradiators B.13.2 Ozone generators B.13.3 Hot-water disinfection systems |
| 61 | Annex C: Water storage and distribution C.1 Introduction C.2 Water storage C.3 Water distribution C.3.1 Configuration C.3.2 Bacterial control devices C.3.2.1 General considerations C.3.2.2 Ultraviolet irradiators |
| 62 | C.3.2.3 Ozone generators C.3.2.4 Hot-water disinfection C.3.2.5 Chemical disinfection |
| 63 | Annex D: Strategies for bacterial control D.1 Introduction D.2 General considerations D.3 Microbial monitoring methods D.3.1 Frequency of monitoring |
| 64 | D.3.2 Sample collection D.3.3 Heterotrophic plate count D.3.3.1 General considerations |
| 65 | D.3.3.2 Membrane-filtration method D.3.3.3 Spread-plate method D.3.3.4 Pour-plate method D.3.4 Bacterial endotoxin test D.4 Action to be taken if microbial levels exceed acceptable limits |
| 67 | Annex E: Thermal disinfection E.1 Introduction E.2 Pasteurization and thermal disinfection |
| 68 | Annex F: Water treatment using filtration F.1 Introduction F.2 Types of filters F.2.1 General considerations F.2.2 Pretreatment filters that remove debris F.2.3 Filters that remove microorganisms F.2.4 Filters that remove chemical solutes |
| 69 | F.3 Producing “sterile water” by 0.2 µm filtration |
| 70 | Annex G: Typical presentation of water quality issues during the reprocessing of medical devices |
| 73 | Annex H: Bibliography |
