The ISO 8536-2 standard, developed by the International Standards Organization (ISO), describes the properties and test methods of medical use infusion bottle caps. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 8536-2 Infusion equipment for medical use - Part 2: Caps for infusion bottles.
The ISO 8536‑2 standard describes the shape, dimensions, material, performance requirements and labels of the caps for infusion bottles as described in the ISO 8536‑1 standard. Dimensional requirements do not apply to barrier coated doors. The covers in this standard are for single use only.
The purpose of this standard is to specify the shape, dimensions and requirements of elastomeric caps designed for infusion bottles. In order to ensure the sealing integrity of the container cover systems, the dimensions of the elastomeric caps, the infusion bottles and the caps must comply with the dimensions specified in the relevant parts of the ISO 8536 standard.
Primary packaging components made of elastomeric materials are an integral part of medical equipment. In this respect, current principles of good manufacturing practice apply to the production of these components.
The strength, purity, stability and safety of a medical equipment during production and storage are greatly affected by its packaging properties.
The following are several standards that are normatively referenced and indispensable for the implementation of the ISO 8536-2 standard:
Within the scope of laboratory services, our organization also provides testing services for ISO 8536-2 medical use infusion bottle caps.
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