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Normas DIN – AENOR
DIN EN ISO 11138-2:2015-10

DIN EN ISO 11138-2:2015-10

Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes (ISO/DIS 11138-2:2015); German and English version prEN ISO 11138-2:2015 / Note: Date of issue 2015-09-11

Stérilisation des produits de santé - Indicateurs biologiques - Partie 2: Indicateurs biologiques pour la stérilisation à l'oxyde d'éthylène (ISO/DIS 11138-2:2015); Version allemande et anglaise prEN ISO 11138-2:2015 / Attention: Date de parution 2015-09-11

Sterilisation von Produkten für die Gesundheitsfürsorge - Biologische Indikatoren - Teil 2: Biologische Indikatoren für Sterilisationsverfahren mit Ethylenoxid (ISO/DIS 11138-2:2015); Deutsche und Englische Fassung prEN ISO 11138-2:2015 / Achtung: Erscheinungsdatum 2015-09-11

Fecha Anulación:
2017-07 /Withdrawn
Equivalencias internacionales:

ISO/DIS 11138-2 (2015-09)

prEN ISO 11138-2 (2015-09)

Relación con otras normas DIN:

Reemplazada por: DIN EN ISO 11138-2:2017-07

Resumen:
This standard provides specific requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within 20 °C to 65 °C.
Keywords:
Bacterial count, Bioassay, Biochemicals, Bio-indicators, Biological hazards, Biological systems, Biological tests, Efficiency, Ethylene oxide, Evaluations, Gas sterilizers, Gases, Germ carrier, Germs, Indicators, Medical devices, Medical equipment, Medical products, Medical sciences, Methods, Microbiological analysis, Microorganisms, Performance, Population, Rating tests, Resistance, Sequence of operations, Specification, Specification (approval), Sterilization (hygiene), Sterilizers, Sterilizing apparatus, Sterilizing gases, Survival characteristics, Systems, Test germs, Test organisms, Testing, Use
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