The ISO 8871-2 standard, developed by the International Organization for Standardization (ISO), describes the properties and test methods of elastomeric parts of devices used for parenteral administration of drugs or serums and for pharmaceutical therapy. This standard has also been published in Turkey by the Turkish Standards Institute (TSE) under the title: TS EN ISO 8871-2 Elastomeric parts for parenteral and pharmaceutical use - Part 2: Identification and specifications.
The said standard describes the evaluation processes applied to elastomeric parts used for medicine containers and medical devices to guarantee product identity between samples evaluated during the conformity test acceptance process and existing materials. Elastomers are essentially a special type of polymer that contains viscosity (resistance to fluidity) and elasticity (elastic deformation of the material under force) in their structure.
The physical and chemical test methods described in this part of the ISO 8871 standard allow the typical properties of rubber materials to be determined and form a basis for agreements between the manufacturer and user on product consistency in subsequent supplies. During the tests, an appropriate test method is chosen depending on the type and application of the rubber. This standard does not specify other requirements for rubber materials. These are included in the relevant product standards.
Elastomeric parts specified in the ISO 8871-2 standard are made of rubber. However, the composition of rubber materials varies significantly. The efficacy, purity, stability and safe use of a drug preparation depends on the proper selection and approval of the rubber portion used. Otherwise, negative effects occur during production, storage and application.
Within the scope of laboratory services, our organization also provides testing services for the elastomeric parts of the devices used for the purpose of administering ISO 8871-2 drugs or serums by intravenous route (parenteral) and drug treatment (pharmaceutical).
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.
