The ISO 80369-1 standard, developed by the International Organization for Standardization (ISO), describes the safety and performance characteristics and test methods of small probe fittings used in various healthcare services, liquids and gases. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 80369-1 Small probe fittings for liquids and gases in healthcare applications - Part 1: General requirements.
This standard describes the general requirements for small bore fasteners that carry liquids or gases in healthcare applications. These small hole fasteners are used in medical devices or accessories intended for use on a patient. It also describes health care areas where these small hole fasteners are intended to be used. Major health areas include, but are not limited to: respiratory systems and driving gases, tube feeding, neuraxial and intravascular or hypodermic.
The ISO 80369-1 standard provides a method for evaluating the non-interconnected properties of small-bore fasteners based on their internal diameter design and size, in order to reduce the risk of misconnections between medical devices or accessories for different applications.
However, this standard does not contain requirements for medical devices or accessories using small hole fasteners. Such requirements are in international standards, especially for certain medical devices or accessories.
The fasteners specified in the ISO 80369 standard series are designed for use only in the specified applications. Using these fasteners for other applications increases the risk of a hazardous and faulty connection.
Our organization also provides safety and performance testing services for small probe fittings used for ISO 80369-1 various health services, liquids and gases, within the scope of laboratory services.
To get an appointment, to get more detailed information or to request an evaluation, you can ask us to fill in our form and reach you.
