ISO 11138-4:2017
Current
Sterilization of health care products — Biological indicators — Part 4: Biological indicators for dry heat sterilization processes
Hardcopy , PDF
English, French
03-03-2017
ISO 11138-4:2017 specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilization processes employing dry heat as the sterilizing agent at sterilizing temperatures within the range of 120 °C to 180 °C.
NOTE 1 Requirements for validation and control of dry heat sterilization processes are provided by ISO 20857.
NOTE 2 Requirements for work place safety can be provided by national or regional regulations.
| Committee |
ISO/TC 198
|
| DevelopmentNote |
Supersedes ISO/DIS 11138-4. (03/2017)
|
| DocumentType |
Standard
|
| Pages |
8
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| NF EN ISO 11138-4 : 2017 | Identical |
| NEN EN ISO 11138-4 : 2017 | Identical |
| NS EN ISO 11138-4 : 2017 | Identical |
| I.S. EN ISO 11138-4:2017 | Identical |
| PN EN ISO 11138-4 : 2017 | Identical |
| SS-EN ISO 11138-4 : 2017 | Identical |
| BS EN ISO 11138-4:2017 | Identical |
| EN ISO 11138-4:2017 | Identical |
| ANSI/AAMI/ISO 11138-4:2017 | Identical |
| CAN/CSA-ISO 11138-4:17 (R2022) | Identical |
| DIN EN ISO 11138-4:2015-10 (Draft) | Identical |
| DIN EN ISO 11138-4:2017-07 | Identical |
| ANSI/AAMI/ISO 11138-4:2017(R2024) | Identical |
| ABNT NBR ISO 11138-4:2023 | Identical |
| SAC GB 18281.4 : 2015 | Identical |
| NBR ISO 11138-4 : 2016 | Identical |
| UNE-EN ISO 11138-4:2017 | Identical |
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