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Chemical Testing for Medical Devices
Chemical Testing for Medical Devices
描述
Characterization for materials used in medical devices – an analysis of a material’s composition, purity, uniformity, sterilant residuals and extractables – is an essential step to verify their suitability for human body contact, thus should not be missed out throughout the product life cycle.

Following the enforcement of RoHS 2 in the European Union, which restricts the use of specified hazardous substances in electrical and electronic equipment, and medical devices are now added to the scope of the Directive and have to be verified as RoHS-compliant.

The chemical laboratory at STC is equipped with the most advanced testing equipment; our team of experts can perform material characterization and RoHS analysis with a wide range of testing methods. We can help manufacturers identify the appropriate testing program based on the intended use of a device and material, and its expected nature of contact with the human body.
 Material Characterization - Guidelines & Standards
  • U.S. FDA Blue Book Memorandum GP#95-1
  • ISO 10993-1, “Biological Evaluation of Medical Devices”
  • ISO 10993-18, “Chemical Characterization of Materials”
  • FDA Guidance Document, “Container Closure Systems for Packaging Human Drugs and Biologics”   
Material Characterization Testing Capabilities
  • Physiochemical Test
  • Fourier Transform Infrared Spectroscopy (FTIR)
  • High-Performance Liquid Chromatography/mass Spectrometry (HPLC-MS)
  • Gas Chromatography / Flame Ionization Detector (GC / FID)
  • Gas Chromatography / Mass Spectrometry (GC / MS)
  • Inductively Coupled Plasma Spectrometry (ICP)
  • Specific Gravity
  • Gel-Permeation Chromatography (GPC)
  • Viscosity
  • Differential Scanning Calorimetry (DSC)
If you have any further question, please feel free contact us at enquiry@stc.group or visit our website: https://www.stc.group/en/contact
香港貿發局參展商
香港標準及檢定中心有限公司 (STC)
香港
服務行業公司
服務行業公司
平均回覆時間:不適用
此認證顯示供應商的信譽及專長,評級分為金、銀、銅三級。
供應商資料最後更新: 2020年10月9日
2001年11月11日登錄於貿發網