DIN EN ISO 11138-6:2026-06
Sterilization of health care products - Biological indicators - Part 6: Biological indicators for vaporized hydrogen peroxide sterilization processes (ISO/DIS 11138-6:2026); German and English version prEN ISO 11138-6:2026 / Note: Date of issue 2026-05-01
| Fecha edición: |
2026-06-01
En Vigor
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| Idiomas disponibles: | Alemán, Inglés |
| Resumen: | This document specifies requirements for test organisms, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing vaporized hydrogen peroxide as the sterilizing agent. NOTE 1 Requirements for validation and control of vaporized hydrogen peroxide sterilization processes are provided by ISO 22441 and ISO 14937. NOTE 2 National or regional regulations can provide requirements for workplace safety. |
| Keywords: | Bacterial count|Bioassay|Biochemicals|Bio-indicators|Biological hazards|Biological systems|Biological tests|Efficiency|Evaluations|Evaporation|Evaporators|Germ carrier|Germs|Hydrogen peroxide|Indicators|Medical devices|Medical equipment|Medical products|Medical sciences|Methods|Microbiological analysis|Microorganisms|Performance|Population|Rating tests|Resistance|Sequence of operations|Specification|Specification (approval)|Steam sterilization|Sterilization (hygiene)|Sterilizers|Sterilizing apparatus|Survival characteristics|Systems|Test germs|Test organisms|Testing|Use|Vapours |
| ICS: | 11.080.01 - Esterilización y desinfeccion en general, 11.080.20 - Desinfectantes y antisépticos |
| CTN: |
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