ISO 11138-2:2017
Current
Sterilization of health care products — Biological indicators — Part 2: Biological indicators for ethylene oxide sterilization processes
Hardcopy , PDF
English, French
03-03-2017
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.
| Committee |
ISO/TC 198
|
| DevelopmentNote |
Supersedes ISO/DIS 11138-2. (03/2017)
|
| DocumentType |
Standard
|
| Pages |
6
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 11138-2:2017-07 | Identical |
| NF EN ISO 11138-2 : 2017 | Identical |
| NEN EN ISO 11138-2 : 2017 | Identical |
| NS EN ISO 11138-2 : 2017 | Identical |
| I.S. EN ISO 11138-2:2017 | Identical |
| PN EN ISO 11138-2 : 2017 | Identical |
| SS-EN ISO 11138-2:2017 | Identical |
| BS EN ISO 11138-2:2017 | Identical |
| EN ISO 11138-2:2017 | Identical |
| ANSI/AAMI/ISO 11138-2:2017 | Identical |
| CAN/CSA-ISO 11138-2:17 (R2022) | Identical |
| DIN EN ISO 11138-2:2015-10 (Draft) | Identical |
| ABNT NBR ISO 11138-2:2021 | Identical |
| GOST ISO 11138-2 : 2012 | Identical |
| NBR ISO 11138-2 : 2016 | Identical |
| AAMI ST21 : 2ED 99 | Corresponds |
| SAC GB 18281.2 : 2000 | Identical |
| GOST R ISO 11138-2 : 2000 | Identical |
| UNE-EN ISO 11138-2:2017 | Identical |
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