EUROLAB, with its state-of-the-art accredited laboratories and expert team, offers precise and rapid testing services within the scope of EN ISO 8537 testing. EN ISO 8537 specifies requirements and test methods for empty, sterile, disposable syringes with or without needles, made of plastic materials and designed solely for insulin injection, where the syringes are filled by the end user. This International Standard covers syringes containing various concentrations of insulin for single human use only.
Insulin syringes specified in this International Standard are intended for use immediately after filling (i.e., insulin injection) and are not intended to contain insulin for an extended period of time.
This International Standard deals primarily with products intended for use with humans and provides performance requirements, but allows some variation in design and methods of packaging and sterilization by individual manufacturers.
The materials to be used in the construction and lubrication of disposable sterile syringes and needles are not specified as their selection will depend to some extent on the design, manufacturing process and sterilization method used by individual manufacturers.
Syringes and needles must be manufactured and sterilized in accordance with recognized national or international rules of good manufacturing practice for medical devices and must be free from defects affecting appearance, safety and serviceability for the intended use.
It is strongly recommended that regulatory authorities, the pharmacopoeia and relevant trade associations recognize the need for further testing for incompatibility between insulins and syringes, especially when in prolonged contact.
EUROLAB assists manufacturers with EN ISO 8537 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.
