DIN EN ISO 11138-7:2019-11
Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results (ISO 11138-7:2019); German version EN ISO 11138-7:2019
| Fecha edición: |
2019-11-01
En Vigor
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| Idiomas disponibles: | Inglés, Alemán |
| Resumen: | This document provides guidance regarding the selection, use and interpretation of results of biological indicators used to develop, validate and monitor sterilization processes. The procedures described in this document are of a general nature and do not, of themselves, constitute a comprehensive development, validation or monitoring programme with regard to the sterilization of health care products. The intent of this document is not to stipulate the use of biological indicators in a process but, if they are used, to provide guidance for their proper selection and use in order to avoid misleading results. |
| Keywords: | Bio-indicators|Definitions|Guide books|Health protection|Indication|Indicators|Interpretation key|Interpretations|Medical devices|Medical equipment|Medical products|Medical sciences|Medical technology|Personal health|Products|Public health|Results|Selection|Specification (approval)|Sterilization (hygiene)|Tracer methods|Use |
| ICS: | 11.080.01 - Esterilización y desinfeccion en general |
| CTN: | |
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Equivalencia Internacional |
Idéntica EN ISO 11138-7:2019 Idéntica ISO 11138-7:2019 |
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Reemplazo Normas |
Reemplaza a DIN EN ISO 11138-7:2017-09 Reemplaza a DIN EN ISO 14161:2010-03 |
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