DIN EN ISO 11140-4:2025-08
Sterilization of health care products - Chemical indicators - Part 4: Type 2 indicator systems as an alternative to the Bowie and Dick-type test for the detection of steam penetration (ISO/DIS 11140-4:2025); German and English version prEN ISO 11140-4:2025 / Note: Date of issue 2025-07-18*Intended as replacement for DIN EN ISO 11140-4 (2007-07).
| Fecha edición: |
2025-08-01
En Vigor
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| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | This document specifies the requirements for a Type 2 chemical indicator to be used in the steam penetration test for steam sterilizers for wrapped health care goods (instruments, etc., and porous materials). Chemical indicators conforming with this document are intended for use in combination with the standard test pack as described in EN 285. This document does not consider the performance of the standard test pack, but does specify the performance of the chemical indicator. |
| Keywords: | Aeration|Ageing (materials)|Air|Biological hazards|Bodies|Bowie and Dick test|Calibration|Checking equipment|Chemical indicators|Classification systems|Conditions|Control|Control charts|Cycle|Defects|Definitions|Density|Determinations|Distance|Equipment|Geometry|Health protection|Heat|Indications|Indicators|Information|Leakage|Lighting systems|Limits (mathematics)|Low pressure|Marking|Measurement|Measuring instruments|Medical devices|Medical products|Medical sciences|Medical technology|Methods|Non-biological|Optics|Packages|Penetrations|Performance|Personal health|Process|Product information|Quality assurance|References|Reflection|Sensitivity|Sensors|Sequence of operations|Signals|Specification|Specification (approval)|Standards|Statistics|Steam sterilization|Steam sterilizers|Sterilization (hygiene)|Sterilizers|Supply|Surveillance (approval)|Systems|Test cycle|Testing|Testing conditions|Tracer methods|Use|Vapours|Verification|Wavelengths |
| ICS: | 11.080.20 - Desinfectantes y antisépticos |
| CTN: |
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