DIN EN ISO 11140-6:2023-02
Sterilization of health care products - Chemical indicators - Part 6: Type 2 indicators and process challenge devices for use in performance testing for small steam sterilizers (ISO 11140-6:2022); German version EN ISO 11140-6:2022
| Fecha edición: |
2023-02-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document specifies the performance requirements and test methods for hollow devices and porous devices as well as the indicators that are utilized within these devices for testing a specific steam penetration performance of type B cycles and some type S cycles of small steam sterilizers that comply with EN 13060. The suitability of the hollow and porous devices described in this document as surrogate devices for hollow and porous medical devices used in health care facilities is not substantiated. |
| Keywords: | Absorption|Aeration|Biological hazards|Calibration|Caps (closures)|Closures|Compatibility|Control|Cycle|Definitions|Determinations|Disposables|Efficiency|Equipment|Extracts|Heat|Hollow bodies|Indications|Indicators|Instruments|Limits (mathematics)|Loading|Low pressure|Marking|Marking of roads|Materials|Medical devices|Medical sciences|Medical technology|Miniature sterilizer|Non-biological|Packages|Performance|Performance requirements|Porous|Pressure overload|Process|Rating tests|Recording instruments|Resistance|Sensors|Signals|Small appliances|Specification (approval)|Stability|Steam sterilization|Steam sterilizers|Sterilization (hygiene)|Sterilizers|Supply|Surveillance (approval)|Systems|Test pieces|Testing|Time|Tracer methods|Use|Vapours|Verification|Water |
| ICS: | 11.080.20 - Desinfectantes y antisépticos |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 11140-6:2022 Idéntica ISO 11140-6:2022 |
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Reemplazo Normas |
Reemplaza a DIN EN 867-5:2001-11 Reemplaza a DIN EN ISO 11140-6:2021-08 |
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