For your sterilized medical devices, we perform cost-effective testing services that deliver reliable results. Our experts also will pre-evaluate any device to develop an appropriate plan for testing.

Cytotoxicity Testing: ISO 10993-5

Medical devices that have direct or indirect contact with body tissue raise quality issues about the biocompatibility of the product and must be tested before being brought to market (CE-certification). Catheters, inhalators, implants, wound dressings and other medical device products must meet the highest quality standards to ensure proper product functioning.

To measure medical device biocompatibility, we provide in vitro cytotoxicity testing. In this type of test, mammalian cells are cultivated with direct contact with the medical device materials, or a material extract of the medical device is pipetted onto precultivated mice cells to test cell vitality.

Our cytotoxicity testing services include:

  • Evaluating the impact of sterilization, packaging and material surface treatment processes on the biocompatibility of products
  • Batch testing during medical device production
  • CE certification of a medical device
  • Testing suppliers’ product quality
  • Comparative testing of biocompatibility of a competitor product

Ethylene Oxide Residual Testing: ISO 10993-7

Ethylene oxide (ETO) is a commonly used sterilant in the manufacture of medical devices because it does not adversely affect the materials used to manufacture medical devices. ISO 10993-7 specifies allowable limits for residual EO and its degradants, ethylene chlorohydrin (ECH) and ethylene glycol (EG).

We provide analytical ETO residual testing of terminally sterilized medical devices using currently accepted gas chromatography (GC) methods:

  • GC water extracts for ETO
  • GC water extracts for EG and ECH
  • GC with solid-phase micro extraction
  • GC using headspace sampling for ETO

Our experts also perform ETO residual testing in compliance with the guidelines provided by ANSI/AAMI/ISO 10993-7.

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