The ISO 11138-1 standard has been designed by the International Organization for Standards (ISO) to describe the properties and testing methods of biological indicators used in the sterilization of health care products.
This standard has also been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 11138-1 Sterilization of health care products - Biological indicators - Part 1: General requirements. In fact, this standard is based on a European standard.
This standard describes the production, labeling, test methods, performance characteristics, and general conditions for routine monitoring of their sterilization processes, including vaccine carriers and suspensions. It also describes the basic and common requirements that apply to other parts of this standard.
Requirements for biological indicators for certain processes are provided in the relevant sections of that standard. However, if no specific requirement is met, the ISO 11138-1 standard is complied with. On the other hand, if there are national or regional regulations, these can also be applied.
On the other hand, the test method described in this standard does not apply to microbiological testing systems in processes based on the physical removal of microorganisms, for example in filtration processes or processes that combine physical and mechanical extraction with microbiological inactivation, such as the use of washer disinfectors or washing and steaming pipelines. However, this standard may contain elements related to such microbiological test systems.
Briefly, the standard covers the production, labeling, test methods and performance characteristics of biological indicators, including the components of the vaccinated carriers and liquid mixtures used in the validity and monitoring of sterilization processes.
Some or all of the contents of the following standards comprise the requirements of this standard: ISO 11135 Sterilization of healthcare products, ISO 11737-1 Sterilization of medical devices, ISO 14937 Healthcare products sterilization, ISO 17665-1 Healthcare products sterilization, ISO 18472 Healthcare products sterilization.
Within the framework of laboratory testing services, our organization also provides sterilization of ISO 11138-1 Healthcare products, biological indicators test services.
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