The ISO 18562 standard has been prepared by the International Standards Organization (ISO) to explain the biocompatibility characteristics and test methods of respiratory devices gas pathways used in health care applications.
In our country, a number of standards have been published by the Turkish Standards Institute (TSE) under the heading of biocompatibility assessment of respiratory gasways in TS EN ISO 18562 Healthcare applications:
The standard in question describes the tests applied for particulate matter emissions, emissions of volatile organic components, and emissions of condensate in a condensate, of a medical device, parts or accessories used for the purpose of delivering substance to a patient in healthcare facilities, hospitals or at home.
This standard also describes the general principles of this type of medical device regulating biological assessment in the risk management process of gasways, parts or accessories, classifies gasways depending on the nature and duration of contacts with gasways, evaluates available data from all sources and is available on the basis of a risk analysis. defines gaps in data. It also defines additional data sets necessary to analyze the biological safety of the gas path and evaluates the biological safety of the gas path.
The ISO 18562 standard also addresses potential contamination of the gas stream from gas paths in the medical device to be delivered to the patient. This standard is valid for the expected service life of the medical device in normal use.
Our organization also provides biocompatibility assessment test services for respiratory gasways in ISO 18562 Healthcare applications within the framework of laboratory testing services.
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