EUROLAB, with its state-of-the-art accredited laboratories and expert team, provides precise and fast testing services within the scope of EN ISO 8871-1 testing. This standard specifies procedures for the classification of elastomeric parts for medical devices and primary packages used in direct contact with preparations for parenteral use, including both aqueous preparations and dry preparations that must be dissolved before use.
It specifies a set of comparative test methods for chemical evaluation by identifying extractables in aqueous autoclaves and identifies various fields of application for elastomeric parts. Dimensions and functional features are specified in the relevant International Standards. The required specifications specified in this part of ISO 8871 are considered minimum requirements.
For empty disposable syringes, elastomeric parts are outside the scope of this part of ISO 8871 as they are not in contact with the injected preparation for a significant period of time.
Compatibility studies with the intended preparation should be carried out in order for final use approval to be granted; however, this part of ISO 8871 does not specify procedures for conducting compliance studies.
EUROLAB assists manufacturers with EN ISO 8871-1 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
