ISO 11138-7:2019
Current
The latest, up-to-date edition.
Sterilization of health care products — Biological indicators — Part 7: Guidance for the selection, use and interpretation of results
Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users
English, French
12-03-2019
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This document provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes.
It does not consider those processes that rely solely on physical removal of microorganisms, e.g. filtration.
It is not applicable to combination processes using, for example, washer-disinfectors or flushing and steaming of pipelines.
It does not specify requirements for the selection and use of biological indicators intended to monitor vaporised hydrogen peroxide processes for isolator and room biodecontamination processes at atmospheric pressure.
It is not applicable to liquid immersion sterilization processes.
| Committee |
ISO/TC 198
|
| DocumentType |
Standard
|
| Pages |
64
|
| ProductNote |
THIS STANDARD ALSO REFERS ISO 11138,ISO 11737,ANSI/AAMI ST79
|
| PublisherName |
International Organization for Standardization
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| PN-EN ISO 11138-7:2019-05 | Identical |
| I.S. EN ISO 11138-7:2019 | Identical |
| SN EN ISO 11138-7:2019 | Identical |
| CSA Z11138-7:21 | Identical |
| NS-EN ISO 11138-7:2019 | Identical |
| UNI EN ISO 11138-7:2019 | Identical |
| BS EN ISO 11138-7:2019 | Identical |
| ÖNORM EN ISO 11138-7:2019 10 15 | Identical |
| EN ISO 11138-7:2019 | Identical |
| ANSI/AAMI/ISO 11138-7:2019 | Identical |
| UNE-EN ISO 11138-7:2020 | Identical |
| DIN EN ISO 11138-7:2019-11 | Identical |
| ABNT NBR ISO 11138-7:2024 | Identical |
| IS 18469 : Part 7 : 2023 | Identical |
| NASA-STD-8719.27:2022 | IMPLEMENTING PLANETARY PROTECTION REQUIREMENTS FOR SPACE FLIGHT |
| ANSI/AAMI/ISO 11138-8:2023 | Sterilization of health care products—Biological indicators—Part 8: Method for validation of a reduced incubation item for a biological indicator |
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