In the ISO 8871-4 standard developed by the International Standards Organization (ISO), the biological properties and test methods of the elastomeric parts of the devices used for the purpose of intravenous (parenteral) and medicinal treatment (pharmaceutical) are described. This standard has been published in our country by the Turkish Standards Institute (TSE) with the following title: TS EN ISO 8871-4 Elastomeric parts for parenteral and pharmaceutical use devices - Part 4: Biological properties and test methods.
The standard describes biological requirements and provides test methods for elastomeric parts for parenterals and devices for pharmaceutical use. That is, it offers extraction methods for elastomeric parts and refers to the relevant biological test methods in the pharmacopoeias and standards.
When elastomeric caps are used as packaging materials that come into direct contact with pharmaceutical preparations, the pharmaceutical industry has to request detailed information from the rubber producing company about the presence of the particles. Annexes between A and D of the standard regulate this request.
On the other hand, if a biosafety issue arises in conjunction with primary packaging materials for pharmaceutical products, the test methods included in the ISO 8871-4 standard are considered as a guideline. In cases of specific applications of the packaging material, the performance of some of the tests listed in the standard annex (Annex A) should be decided upon between users and manufacturers.
The standard that is referred to as normative in the application of this standard and indispensable for its implementation is the following: TS EN ISO 10993-5 Biological evaluation of medical devices - Part 5: Extracorporeal cytotoxicity tests.
Within the scope of laboratory services, our organization also provides biological testing services for the elastomeric parts of the devices used for the intravenous (parenteral) delivery of drugs or serums and medicated treatment (pharmaceutical) in accordance with ISO 8871-4 standard.
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