TS EN ISO 8536-4 Infusion Equipment for Medical Use - Part 4: Gravity-Action Disposable Infusion Sets

The ISO 8536-4 standard, developed by the International Standards Organization (ISO), describes the characteristics and test methods of disposable infusion sets, which are infusion equipment for medical use and work with the effect of gravity. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 8536-4 Infusion equipment for medical use - Part 4: Disposable infusion sets operating under the effect of gravity.

The said standard describes the requirements of gravity feeding infusion sets for single use, medical use to ensure compatibility with containers for infusion solutions and equipment used in the form of therapy where liquid medicine is administered directly through the vein. In addition, this standard provides guidance on specifications for the quality and performance of materials used in infusion sets and introduces infusion set components.

Here are a few standards that are referred to as normative in the application of the ISO 8536-4 standard and are indispensable for its implementation:

• TS EN ISO 3696 Water - Used in analytical laboratory - Properties and test methods
• TS EN ISO 7864 Disposable sterile hypodermic needles - Requirements and test methods
• TS EN ISO 8536-13 Infusion equipment for medical use - Part 13: Disposable grade flow regulators with liquid contact
• TS EN ISO 8536-14 Infusion equipment for medical use - Part 14: Clamps and flow regulators for transfusion and infusion equipment without fluid contact
• Clean rooms and their controlled environments - Part 14644: Classification of air purity by particle concentration

Within the scope of laboratory services, our organization also provides disposable infusion sets testing services with ISO 8536-4 medical infusion equipment and working with the effect of gravity.