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SFS-EN ISO 11138-1:2017:en
Sterilization of health care products. Biological indicators. Part 1: General requirements (ISO 11138-1:2017)
Soveltamisala
Suomenkielistä soveltamisalaa ei ole saatavissa.
?ISO 11138-1:2017 specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.
ISO 11138-1:2017 specifies basic and common requirements that are applicable to all parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO 11138. If no specific subsequent part is provided, this document applies.
NOTE National or regional regulations can apply.
ISO 11138-1:2017 does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This document, however, can contain elements relevant to such microbiological test systems.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
?ISO 11138-1:2017 specifies general requirements for production, labelling, test methods and performance characteristics of biological indicators, including inoculated carriers and suspensions, and their components, to be used in the validation and routine monitoring of sterilization processes.
ISO 11138-1:2017 specifies basic and common requirements that are applicable to all parts of ISO 11138. Requirements for biological indicators for particular specified processes are provided in the relevant parts of ISO 11138. If no specific subsequent part is provided, this document applies.
NOTE National or regional regulations can apply.
ISO 11138-1:2017 does not apply to microbiological test systems for processes that rely on physical removal of microorganisms, e.g. filtration processes or processes that combine physical and/or mechanical removal with microbiological inactivation, such as use of washer disinfectors or flushing and steaming of pipelines. This document, however, can contain elements relevant to such microbiological test systems.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
Sisällysluettelo
Tuoteryhmä(t)
Sidokset
Velvoittavat viittaukset
ISO 11135:2014 Sterilization of health-care products -- Ethylene oxide -- Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11737-1:2006 Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products
ISO 14937:2009 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
ISO 11737-1:2006 Sterilization of medical devices -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products
ISO 14937:2009 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
Tekninen komitea
Vahvistuspäivä
07.04.2017
Julkaisupäivä
11.04.2017
Painos
2
Sivumäärä
46
Julkaisun kieli
englanti