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AAMI TIR16 : 2017

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

MICROBIOLOGICAL ASPECTS OF ETHYLENE OXIDE STERILIZATION
Superseded date

02-16-2023

Published date

11-17-2017

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)
DocumentType
Technical Report
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
Status
Superseded
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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