GC-MS 1

Typ

QP 2010 Ultra

Anschaffungsdatum

Hersteller

Shimadzu Deutschland GmbH

Datenblatt

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Gerätespezifische Methoden:

  • Ph. Eur. 2.2.43 | Mass spectrometry
  • DIN EN ISO 10993-7 | Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
  • DIN EN ISO 10301 | Water quality - Determination of highly volatile halogenated hydrocarbons - Gas-chromatographic methods
  • Ph. Eur. 3.1.15 | Polyethylene terephthalate for containers for preparations not for parenteral use
  • Ph. Eur. 3.1.14 | Materials based on plasticised poly(vinyl chloride) for containers for aqueous solutions for intravenous infusion
  • Ph. Eur. 3.1.10 | Materials based on non-plasticised poly(vinyl chloride) for containers for non-injectable, aqueous solutions
  • Ph. Eur. 3.1.9 | Silicone elastomer for closures and tubing
  • Ph. Eur. 3.1.8 | Silicone oil used as a lubricant
  • Ph. Eur. 3.1.7 | Poly(ethylene - vinyl acetate) for containers and tubing for total parenteral nutrition preparations
  • Ph. Eur. 3.1.6 | Polypropylene for containers and closures for parenteral preparations and ophthalmic preparations
  • Ph. Eur. 3.1.5 | Polyethylene with additives for containers for parenteral preparations and for ophthalmic preparations
  • Ph. Eur. 3.1.4 | Polyethylene without additives for containers for parenteral preparations and for ophthalmic preparations
  • Ph. Eur. 3.1.3 |  Polyolefins
  • Ph. Eur. 2.4.25 | Ethylenoxide and Dioxane
  • Ph. Eur. 2.4.24 | Identification and control of residual solvents
  • DIN EN ISO 10993-9 | Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products 
  • DIN EN ISO 10993-13 | Biological evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices 
  • Ph. Eur. 3.1.11 | Materials based on non-plasticised poly(vinyl chloride) for containers for solid dosage forms for oral administration
  • DIN EN ISO 10993-18 | Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process