Frequently Asked Questions
Which standards apply to EKINSUN medical components?
Manufacturing runs under ISO 13485 and ISO 9001 quality management systems. Assembly and packaging take place in a Class 100,000 cleanroom, which corresponds to ISO Class 8 under ISO 14644-1. Biological safety follows the ISO 10993 series, with USP Class VI documentation available for the resin grade. Ethylene oxide sterilization follows ISO 11135, with residual limits per ISO 10993-7. Luer and small-bore connectors are made to ISO 594 and the ISO 80369 series.
Do you supply ISO 10993 biocompatibility documentation?
Yes, for the resin grade. Medical-grade polymers are supplied with the compounder's biological evaluation data, typically covering ISO 10993-5 cytotoxicity, ISO 10993-10 irritation and sensitisation, and USP Class VI where the grade carries it. That documentation covers the material. Biological evaluation of your finished device, which accounts for geometry, processing, sterilization and patient contact duration, is a submission-level activity carried out by the legal manufacturer of the device.
How is ethylene oxide sterilization handled?
EO is the usual route for disposable polymer components such as stopcocks, manifolds, extension tubes and Luer connectors. Sterilization is performed by a licensed provider to ISO 11135, with the cycle validated for your specific product, packaging and load configuration. Residual ethylene oxide and ethylene chlorohydrin are verified against ISO 10993-7 limits for the contact category. The sterilization certificate and residual test report are issued with the batch. Gamma irradiation is available where the resin grade tolerates it.
What is the difference between ISO 594 and ISO 80369?
ISO 594 is the older Luer taper standard covering 6% conical fittings for syringes and needles. The ISO 80369 series replaces it with application-specific connector geometries designed to prevent misconnection between different clinical routes, with ISO 80369-7 covering intravascular and hypodermic connectors. Many markets are still in transition, so specify which standard your device must meet. We tool and gauge to whichever applies, and the dimensional inspection report references that standard by name.
Do you perform IQ, OQ and PQ validation?
Yes, for tooling and molding processes on medical programmes. Installation qualification confirms the tool and machine are correctly installed, operational qualification establishes the process window across parameter ranges, and performance qualification demonstrates sustained output at production settings. The validation protocol is agreed before tooling is cut, so the acceptance criteria are yours rather than a generic template. Executed protocols are supplied for your device master record.
What documents arrive with a shipment?
Standard with every medical shipment: material certificate or COA for the resin lot, dimensional inspection report against the approved drawing, lot and batch traceability records, and the packing list. Supplied when your specification calls for them: biocompatibility documentation for the resin grade, EO sterilization certificate with residual test results, bioburden or sterility test report, first article inspection report, and executed IQ/OQ/PQ protocols. Tell us what your supplier qualification file needs and we confirm what can be issued before you order.
