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AAMI TIR56:2013(R2020)

Current
Current

The latest, up-to-date edition.

GUIDANCE FOR THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF AN ETHYLENE OXIDE STERILIZATION PROCESS UTILIZING FLEXIBLE BAG SYSTEMS FOR THE STERILIZATION OF MEDICAL DEVICES
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

10-18-2016

Glossary of equivalent standards
Committee representation
Foreword
Introduction
1 Scope
2 Terms and definitions
3 Process descriptions
4 Quality management systems
5 Sterilizing agent characterization
6 Process and Equipment Characterization
7 Product definition
8 Process definition
9 Validation
10 Routine Monitoring and Control
11 Product Release from Sterilization
12 Maintaining Process Effectiveness
Annexes
Annex A (informative) - Microbial Validation Using an
        Augmented Overkill Approach
Annex B (informative) - Microbial Validation Using
        Reduced EO Concentration
Bibliography

Defines information to be considered during the development, validation, and routine control of EO sterilization processes that are performed using gas diffusion within individually sealed flexible sterilization bags.

DocumentType
Standard
ISBN
978-1-57020-519-4
Pages
39
ProductNote
Reconfirmed 2016
PublisherName
Association for the Advancement of Medical Instrumentation
Status
Current
Supersedes

AAMI ST41 : 2008 ETHYLENE OXIDE STERILIZATION IN HEALTH CARE FACILITIES: SAFETY AND EFFECTIVENESS
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
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 TIR17 : 2008 COMPATIBILITY OF MATERIALS SUBJECT TO STERILIZATION
AAMI ISO 14161 : 2009 STERILIZATION OF HEALTH CARE PRODUCTS - BIOLOGICAL INDICATORS - GUIDANCE FOR THE SELECTION, USE, AND INTERPRETATION OF RESULTS
CFR 29(PT1910.1000 TO END) : 0 LABOR - OCCUPATIONAL SAFETY AND HEALTH ADMINISTRATION, DEPARTMENT OF LABOR
ISO 10012:2003 Measurement management systems — Requirements for measurement processes and measuring equipment
NFPA 30 : 2018 FLAMMABLE AND COMBUSTIBLE LIQUIDS CODE
AAMI/ISO 13485:2016 MEDICAL DEVICES - QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS FOR REGULATORY PURPOSES

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