The ISO 8536-1 standard, developed by the International Standards Organization (ISO), describes the properties and test methods of glass infusion bottles for medical use. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 8536-1 Infusion equipment for medical use - Part 1: Glass infusion bottles.
This standard describes the dimensions, performance and requirements of infusion glass bottles required to ensure functional interchangeability. This standard applies to single use infusion bottles only.
Infusion bottles are the primary packaging materials generally used for the storage and storage of infusion solutions until they are given to the patient. There is direct contact between the infusion solution and the primary container components. Considering this situation and long storage times, possible interactions should be avoided to ensure patient safety. In order to achieve this, special conditions and test methods must be applied in order to select the primary packaging materials correctly, to select the appropriate packaging design and to test individual container systems.
The following are several standards that are normatively referenced and indispensable for the implementation of the ISO 8536-1 standard:
Our organization also provides testing services for ISO 8536-1 glass infusion bottles for medical use within the scope of laboratory services.
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