AAMI ST77 2013 RA 2018
$93.55
ANSI/AAMI ST77:2013/(R)2018 – Containment devices for reusable medical device sterilization
| Published By | Publication Date | Number of Pages |
| AAMI | 2013 | 34 |
This standard covers minimum labeling and performance requirements for rigid sterilization container systems and for instrument organizers.
PDF Catalog
| PDF Pages | PDF Title |
|---|---|
| 1 | ANSI/AAMI ST77:2013/(R)2018, Containment devices for reusable medical device sterilization |
| 2 | Objectives and uses of AAMI standards and recommended practices |
| 3 | Title page |
| 4 | AAMI standard Copyright information |
| 5 | Contents |
| 6 | Glossary of equivalent standards |
| 7 | Committee representation |
| 10 | Foreword |
| 11 | Introduction 1 Scope 1.1 General |
| 12 | 1.2 Inclusions 1.3 Exclusions |
| 13 | 2 Normative references |
| 14 | 3 Definitions and abbreviations |
| 17 | 4 Requirements 4.1 General 4.2 Materials of construction 4.2.1 Durability 4.2.2 Compatibility with the sterilization process 4.2.3 Corrosion resistance 4.2.4 Biocompatibility 4.3 Design 4.3.1 General |
| 18 | 4.3.2 Decontamination 4.3.3 Perforations 4.3.4 Stacking 4.3.4.1 Internal stacking 4.3.4.2 External stacking |
| 19 | 4.3.5 Maximum weight 4.3.6 Additional requirements for reusable rigid sterilization containers 4.3.6.1 Gaskets 4.3.6.2 Filters |
| 20 | 4.3.6.3 Valves (if applicable) 4.3.6.4 Handles 4.3.6.5 Lid-base compatibility 4.3.6.6 Latching mechanisms 4.3.6.7 Tamper-evident system |
| 21 | 4.4 Performance 4.4.1 Sterilization 4.4.1.1 General Requirements 4.4.1.2 Reconfiguration and combining of cases and sets 4.4.1.3 Documentation |
| 22 | 4.4.2 Drying (if applicable) 4.4.2.1 General Requirements 4.4.2.2 Documentation |
| 23 | 4.4.3 Sterilant residual removal (if applicable) 4.4.3.1 General Requirements 4.4.3.2 Documentation 4.4.4 Sterility maintenance 4.4.4.1 General Requirements |
| 24 | 4.4.4.2 Documentation 4.5 Labeling requirements 4.5.1 Device markings 4.5.2 Instructions for use (IFU) |
| 26 | 5 Tests 5.1 General 5.2 Biocompatibility 5.3 Gaskets and filters 5.4 Valves 5.5 Handles 5.6 Sterilization |
| 28 | 5.7 Drying (if applicable) 5.8 Sterilant residual removal (if applicable) 5.9 Sterility 5.9.1 Sterility maintenance 5.9.1.1 General 5.9.1.2 Whole-package microbial challenge test 5.9.1.3 Physical integrity tests |
| 29 | Annex A (Informative) Medical device integration with rigid sterilization container systems A.1 Introduction A.2 Critical assessments |
| 31 | A.3 Validation plan A.4 FDA clearance considerations |
| 32 | A.5 Change control |
| 33 | Bibliography |
