UNE-EN ISO 11138-7:2020
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 (ISO 11138-7:2019)
Hardcopy , PDF
English, Spanish, Castilian
12-02-2020
This International Standard provides guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring ofsterilization processes.1.1 ExclusionsThis International Standard does not consider those processes that rely solely on physical removal of microorganisms, e.g., filtration.This International Standard is not intended to apply to combination processes using, for example, washerdisinfectors or flushing and steaming of pipelines.This International Standard does not specify requirements for the selection and use of biological indicators intended to monitor vaporised hydrogen peroxide processes for isolator and room biodecontaminationprocesses at atmospheric pressure.This International Standard is not intended to apply to liquid immersion sterilization processes.
| Committee |
CTN 111
|
| DocumentType |
Standard
|
| Pages |
74
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
| Standards | Relationship |
| ISO 11138-7:2019 | Identical |
| EN ISO 11138-7:2019 | Identical |
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