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.

23 related Medical device resources related to Clinical Evaluation
  • 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.

35 related Medical device resources related to Medical Device Material Compatibility Testing
  • 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.

36 related Medical device resources related to Medical Device Cleaning Validation
  • 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.

30 related Medical device resources related to Disinfection Sprays for Medical Devices
  • 2-3 week typical lead time
  • UKAS accredited
  • Bactericidal, fungicidal, yeasticidal
  • Sporicidal, mycobactericidal
  • Virucidal
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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.

36 related Medical device resources related to Medical Device Cleaning Validation
  • 4-5 week typical lead time
  • Simulated use/accumulation study
  • BS EN ISO 17664-1:2021
  • ANSI/AAMI ST98/ISO 15883-5
  • ASTM F3208-20
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Medical Device Disinfection Validation

Medical Device Disinfection Validation

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

36 related Medical device resources related to Medical Device Disinfection Validation
  • 4-5 week typical lead time
  • Simulated use/accumulation study
  • BS EN ISO 17664-1:2021
  • ANSI/AAMI ST98/ISO 15883-1/2
  • AAMI TIR12:2020
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Medical Device Sterilisation Validation

Medical Device Sterilisation Validation

We validate your medical device sterilisation instructions, which can be moist heat, low temperature hydrogen peroxide or other process.

36 related Medical device resources related to Medical Device Sterilisation Validation
  • 4-5 week typical lead time
  • Simulated use/accumulation study
  • BS EN ISO 17664-1:2021
  • ISO 14937:2009
  • BS EN ISO 17665:2024
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