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The EN ISO 11737-1 standard specifies requirements for the enumeration and microbial characterization of the living microorganism population on or in a healthcare product, component, raw material or package, and offers test methods for determining the microorganism population.
This standard is not intended for the counting or identification of viral, prion or protozoan contaminants. However, spongy involves detecting and removing agents that cause brain damage and malfunctions. Guidelines on deactivating viruses and prions are included in ISO 22442‑3, ICH Q5A (R1) and ISO 13022 standards.
In our country, this standard has been published by the Turkish Standards Institute (TSE) with the following title: EN ISO 11737-1 Sterilization of health care products - Microbiological methods - Part 1: Detection of microorganism population on products.
A sterile health care product is a product that does not contain live microorganisms. International standards that specify the requirements for the verification and routine control of sterilization processes require the minimization of microbiological contamination of a health care product before sterilization when a sterile health care product is to be used. The purpose of sterilization is to neutralize microbiological contaminants and in this way turn non-sterile products into sterile products.
There is always a limited probability that a microorganism will survive. The probability of survival for a given treatment depends on the number and resistance of the microorganisms and the environmental conditions in which the microorganisms were found during the procedure.
Bioburden refers to a population of living microorganisms on or within a product or sterile barrier system. Bioburden is the sum of microbial additives from a range of sources, including raw materials, manufacturing of components, assembly processes, production environment, cleaning processes and packaging of finished products. Microbiological tests must be performed to check the biological burden.
With the experience gained over many years, our organization also provides services for ISO 11737-1 Sterilization of medical devices - Microbiological methods - Part 1: Detection of the microorganism population on the product, within the framework of laboratory services of the materials with a trained and expert staff.
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Our organization operates in a nationally and internationally approved, independent and impartial manner, in order to increase the product quality of enterprises and to prevent possible commercial risks in international trade. It provides audit, surveillance, inspection, testing, measurement and analysis services for businesses of all sectors and sizes, evaluates, reports and documents.
