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DIN EN ISO 11138-5

Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017); German version EN ISO 11138-5:2017

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Organization: DIN
Publication Date: 1 July 2017
Status: active
Page Count: 16
ICS Code (Disinfectants and antiseptics): 11.080.20
scope:

Dieses Dokument legt spezifische Anforderungen an Prüfkeime, Suspensionen, beimpfte Keimträger, biologische Indikatoren und Prüfverfahren fest, die für die Anwendung bei der Beurteilung der Leistung von Sterilisationsverfahren vorgesehen sind, die Niedertemperatur-Dampf-Formaldehyd als sterilisierendes Agens anwenden.

ANMERKUNG 1 Anforderungen an die Validierung und Überwachung von Sterilisationsverfahren mit Niedertemperatur-Dampf-Formaldehyd sind in ISO 14937 angegeben.

ANMERKUNG 2 Anforderungen an die Sicherheit am Arbeitsplatz können in nationalen oder regionalen Bestimmungen festgelegt sein.

Document History

DIN EN ISO 11138-5
July 1, 2017
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2017); German version EN ISO 11138-5:2017
Dieses Dokument legt spezifische Anforderungen an Prüfkeime, Suspensionen, beimpfte Keimträger, biologische Indikatoren und Prüfverfahren fest, die für die Anwendung bei der Beurteilung der Leistung...
DIN EN ISO 11138-5
October 1, 2015
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO/DIS 11138-5:2015); German and English version prEN ISO 11138-5:2015
A description is not available for this item.
DIN EN ISO 11138-5 Berichtigung 1
September 1, 2007
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2006); German version EN ISO 11138-5:2006, Corrigenda to DIN EN ISO 11138-5:2006-09
A description is not available for this item.
DIN EN ISO 11138-5
September 1, 2006
Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes (ISO 11138-5:2006); German version EN ISO 11138-5:2006
A description is not available for this item.
DIN EN ISO 11138-5
September 1, 2004
Sterilization of health care products - Biological indicator systems - Part 5: Use in assessing low-temperature-steam- formaldehyde sterilization processes (ISO/DIS 11138-5:2004); German version prEN ISO 11138-5:2004
A description is not available for this item.

References

This document references:
DIN EN 14180 - Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing
Published by DIN on September 1, 2014
This European Standard specifies requirements and tests for LTSF sterilizers, which use a mixture of low temperature steam and formaldehyde as sterilizing agent, and which are working below ambient...
This document references:
ISO 11138-1 - Sterilization of health care products - Biological indicators - Part 1: General requirements
Published by ISO on March 1, 2017
This document specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their...
This document references:
ISO 14937 - Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
Published by ISO on October 15, 2009
Inclusions This International Standard specifies general requirements for the characterization of a sterilizing agent and for the development, validation and routine monitoring and control of a...
This document references:
ISO 25424 - Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices
Published by ISO on October 1, 2018
Inclusions This document specifies requirements for the development, validation and routine control of a low temperature steam and formaldehyde (LTSF) sterilization process for medical devices using...
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