ISO 11138-2:2017
Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
ISO 11138-2:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.
NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 11135 and ISO 14937.
NOTE 2 National or regional regulations can provide requirements for work place safety.
| Get this standard | Prices exclude GST | |
|---|---|---|
| PDF ( Single user document) |
$83.00 NZD
|
|
| Networkable PDF |
Price varies
|
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Test organism
6 Suspension
7 Carrier and primary packaging
8 Inoculated carriers and biological indicators
9 Population and resistance
Annex A (normative) Method for determination of resistance to ethylene oxide sterilization
Annex B (informative) Rationale for the inclusion of a second minimum D value specification as a result of changes to the test gas used to evaluate resistance and deletion of the requirement for a minimum D value at 30 °C
Bibliography
Previous versions
Keep me up-to-date
Sign up to receive updates when there are changes to this standard
Related Information
Similar Standards
-
AS/NZS ISO 11137.1:2006
Sterilization of health care products - Radiation - Requirements for development, validation and routine control of a sterilization process for medical devices
-
AS/NZS ISO 11137.3:2006
Sterilization of health care products - Radiation - Guidance on dosimetric aspects
-
BS EN 556-1:2024
Sterilization of medical devices. Requirements for medical devices to be designated "STERILE", Requirements for terminally sterilized medical devices
-
BS EN 556-1:2024 - TC
Tracked Changes. Sterilization of medical devices. Requirements for medical devices to be designated "STERILE", Requirements for terminally sterilized medical devices
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 General requirements
5 Test organism
6 Suspension
7 Carrier and primary packaging
8 Inoculated carriers and biological indicators
9 Population and resistance
Annex A (normative) Method for determination of resistance to ethylene oxide sterilization
Annex B (informative) Rationale for the inclusion of a second minimum D value specification as a result of changes to the test gas used to evaluate resistance and deletion of the requirement for a minimum D value at 30 °C
Bibliography