AAMI TIR56:2013(R2024)
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
26-03-2024
€157.50
Excluding VAT
This AAMI Technical Information Report (TIR) provides 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 |
Guide
|
| ISBN |
978-1-57020-519-4
|
| Pages |
41
|
| PublisherName |
Association for the Advancement of Medical Instrumentation
|
| Status |
Current
|
| Supersedes |
| ANSI/AAMI/ISO 11737-2:2019 | <br>Sterilization of medical devices—Microbiological methods—Part 2: Tests of sterility performed in the definition, validation and maintenance of a sterilization process |
| 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 TIR17:2017(R2023) | Compatibility of materials subject to sterilization |
| ANSI/AAMI/ISO 13485:2016(R2019) | Medical devices—Quality management systems— Requirements for regulatory purposes |
| ANSI/AAMI/ISO 11138-2:2017(R2024) | Sterilization of health care products—Biological indicators—Part 2: Biological indicators for ethylene oxide sterilization processes |
| ANSI/AAMI/ISO 11140-1:2014 | Sterilization of health care products - Chemical indicators - Part 1: General requirements. |
| AAMI ISO 10993-7:2008(R2012) | BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS |
| ANSI/AAMI ST41:2008(R2018) | Ethylene oxide sterilization in health care facilities: Safety and effectiveness |
| ANSI/AAMI/ISO 11737-1:2018 | Sterilization of health care products—Microbiological methods—Part 1: Determination of a population of microorganisms on products |
| AAMI TIR28:2016(R2020) | Product adoption and process equivalence for ethylene oxide sterilization |
| ANSI/AAMI/ISO 14937:2009(R2013) | STERILIZATION OF HEALTH CARE PRODUCTS - GENERAL REQUIREMENTS FOR CHARACTERIZATION OF A STERILIZING AGENT AND THE DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES |
Summarise
Access your standards online with a subscription
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.
Important note : Users cannot be edited or removed once added to your Multi user PDF.