AAMI TIR16 : 2017
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
MICROBIOLOGICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION
16-02-2023
17-11-2017
Glossary of equivalent standards
Committee representation
Foreword
1 Scope
2 Terms and definitions
3 Process and equipment characterization
4 Process definition
5 Validation
6 Maintaining process effectiveness
Bibliography
Specifies various microbiological aspects of the development and validation of an ethylene oxide (EO) sterilization process.
| DevelopmentNote |
Formerly it was AAMI ST27 (It is an updated material from ANSI/AAMI ST27:1988 (05/2001)
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| DocumentType |
Technical Report
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| ProductNote |
Formerly it was AAMI ST27 (It is an updated material from ANSI/AAMI ST27:1988) (Amit 05/2001)
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
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| Status |
Superseded
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| SupersededBy | |
| Supersedes |
| AAMI ST35 : 3ED 2003 | SAFE HANDLING AND BIOLOGICAL DECONTAMINATION OF REUSABLE MEDICAL DEVICES IN HEALTH CARE FACILITIES AND IN NONCLINICAL SETTINGS |
| ANSI/AAMI/ISO 17664:2017 | PROCESSING OF HEALTH CARE PRODUCTS - INFORMATION TO BE PROVIDED BY THE MEDICAL DEVICE MANUFACTURER FOR THE PROCESSING OF MEDICAL DEVICES |
| AAMI TIR34 : 2014 | WATER FOR THE REPROCESSING OF MEDICAL DEVICES |
| ANSI/AAMI/ISO 11135:2014 | STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
| ISO 11135:2014 | Sterilization of health-care products — Ethylene oxide — Requirements for the development, validation and routine control of a sterilization process for medical devices |
| CFR 21(PTS800-1299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
| AAMI TIR28 : 2016 | PRODUCT ADOPTION AND PROCESS EQUIVALENCE FOR ETHYLENE OXIDE STERILIZATION |
| ANSI/AAMI/ISO 11138-2:2017 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 2: BIOLOGICAL INDICATORS FOR ETHYLENE OXIDE STERILIZATION PROCESSES |
| AAMI TIR15 : 2016 | PHYSICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION |
| AAMI ISO 14161 : 2009 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE, AND INTERPRETATION OF RESULTS |
| ANSI/AAMI/ISO 11138-1:2017 | STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - PART 1: GENERAL REQUIREMENTS |
| AAMI TIR14 : 2016 | CONTRACT STERILIZATION USING ETHYLENE OXIDE |
| AAMI TIR 8 : 1ED 91 | MICROBIOLOGICAL METHODS FOR GAMMA IRRADIATION STERILIZATION OF MEDICAL DEVICES |
| ISO 9000-1:1994 | Quality management and quality assurance standards — Part 1: Guidelines for selection and use |
| EN 1422:2014 | Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods |
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