Services available for Disinfectant Sprays

Clinical Evaluation

Clinical Evaluation

We develop and implement a methodologically sound procedure to collect, appraise, and analyse clinical data pertaining to your medical device.

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  • 8-10 week typical lead time
  • Comply with Article 61 and Part A of Annex XIV of MDR
  • Pre- and Post-market clinical data
  • Following MEDDEV 2.7.1 Rev 4
  • CE & UKCA
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Medical Device Material Compatibility Testing

Medical Device Material Compatibility Testing

We analyse test item materials at both sample and product level to assess process compatibility.

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  • Starts from 2-3 week typical lead time
  • Spray tests, based on EN ISO 21530
  • Soak tests, based on EN ISO 21530
  • Contact tests, based on EN ISO 21530
  • Wipe tests, based on BIFMA HCF 8.1-2017
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Medical Device Cleaning Validation

Medical Device Cleaning Validation

We validate your medical device cleaning instructions, as detailed in your IFU, which can be manual or automated.

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  • 4-5 week typical lead time
  • Simulated use/accumulation study
  • AAMI ST98/ISO 15883-5
  • Validated via residual analyte detection (Protein & ATP)
  • High/Low level disinfection validation to AAMI TIR-12
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Disinfection Sprays for Medical Devices

Disinfection Sprays for Medical Devices

We will determine the efficacy of your medical device disinfectant spray, as well as perform Material Compatibility tests.

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  • 2-3 week typical lead time
  • UKAS accredited
  • Bactericidal, fungicidal, yeasticidal
  • Sporicidal, mycobactericidal
  • Virucidal
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