SS ISO 11138-7:2019
Sterilisation of health care products – Biological indicators
OVERVIEW
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 sterilisation processes.
Does not consider those processes that rely solely on physical removal of microorganisms, e.g. filtration.
Not applicable to combination processes using, for example, washer-disinfectors or flushing and steaming of pipelines.
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.
Not applicable to liquid immersion sterilisation processes.
COMMENTS
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PRODUCT DETAILS
| Status | Current |
|---|---|
| Edition | 2019 |
| No. of Pages | 78 |
| ICS Classification | 11.080.01 Sterilization and disinfection in general |
| Committee | Biomedical and Health Standards Committee |
| Available for Purchase | Global |
| Adoption | ISO 11138-7 : 2019 IDT |