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In the complex field of assisted reproduction there can be no compromises –Swemed is synonymous with quality. Quality of raw materials, quality of design, quality of testing, quality of performance. We have built our worldwide reputation on the production of precision crafted, superior quality needles for ultrasound guided puncture and unsurpassed precision in microtool instrumentation. First to introduce ultrasound guided needles Swemed instruments are designed in collaboration with leading doctors and scientists and can be supplied in unique tolerance levels. Swemed has always been to the fore in research and development in this field and were the first to introduce ultrasound guided needles which revolutionised transvaginal aspiration and cyst puncture. Our ultrasound, amniocentesis and cyst puncture needles can be supplied with measurements in accordance with your own specifications. Our control – your guarantee Only a Swemed pipette gives you precision to 0.001 mm. Our highly trained staff check, measure and test each individual instrument guaranteeing you consistent performance and standards of excellence. In addition to our own stringent procedures, our products and manufacturing facilities are continuously monitored by independent, accredited laboratories and are subjected to strict quality assurance and performance criteria. Sterilization that exceeds your demands Swemed has developed a unique dry heat sterilization process at 160°C/320°F for pipettes preventing any risk caused by residuals from other sterilization methods such as ETO. Our needles are steam sterilized to preclude any possibility of chemical or other trace residuals. All raw materials are therefore carefully selected to tolerate exposure to heat and humidity during the sterilization process without causing changes in the physical appearance or properties of the various instruments. Quality control and Regulatory standards The Swemed clean room area is Class 10000 certified and undergoes regular microbiological screening. Swemed´s quality management system complies with ISO9002 and EN46002 standards. All Swemed devices shown on this site have attained the European CE Mark. Devices sold in the United States of America have 510K approvals from the FDA. All materials used in our manufacturing process are subjected to comprehensive quality control testing and materials that will come in contact with gametes are subjected to the following tests: The Mouse Embryo Assay (MEA), using two-cell mouse stage embryos which are observed to the hatched blastocyst. Items are approved if growth of 80% or more is supported. The Limulus Amebocyte Lysate (LAL test for endotoxin. Items are approved at an endotoxin level of less than 0.1 EU/ml. |
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