Services available for UV-C Disinfection Devices
Medical Device Cleaning Validation
We validate your medical device cleaning instructions, as detailed in your IFU, which can be manual or automated.
- 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
Medical Device Reprocessing Validation
We validate the full reprocessing lifecycle of your medical device, delivering the evidence you need to demonstrate regulatory compliance, ensure patient safety, and protect product longevity.
- 4-8 week typical lead time
- Custom test rigs
- Bespoke testing setups
- Cleaning, Disinfection & Sterilisation cycles
- AAMI TIR30Â / ANSI/AAMI ST98:2022
Medical Device Reprocessing Instructions Development
We develop cleaning instructions for medical devices, whether manual or automated, to ensure your process is fully validated.
- 2-4 week typical lead time
- Cleaning, Disinfection & Sterilisation
- IFU Development
- BS EN ISO 17664-1:2021
- ANSI/AAMI ST98/ISO 15883-5
Extractables & Leachables (E&L) Testing
We offer comprehensive Extractables & Leachables (E&L) testing to identify and quantify substances, supporting your product’s biocompatibility and regulatory compliance.
- 2-4 week typical lead time
- ISO 10993-18
- USP<1663>/<1664>, USP <665>/<1665>
- Aligned with MDR and FDA guidance
- Custom Extractables Study Design
R&D Medical Device Testing Support
Whether you’re refining a prototype, investigating a failure mode, or pushing the limits of what your device can do, we’re here to provide the technical testing support you need.
- 4-8 week typical lead time
- Custom test rigs
- Bespoke testing setups
- Proof-of-concept testing
- Cross-disciplinary support
IEC 60601-1-2 EMC Testing
We offer EMC test program for active medical devices and/or systems, which defines emission and immunity criteria per IEC 60601-1-2
- 2-4 week typical lead time
- ISO 17025 Accredited testing program
- IECEE CB Scheme testing and
- IEC 60601-1-2:2020 (ed. 4.1) – Medical electrical
equipment - Review and verification of EMC test plans, risk analysis, and user manuals
IEC 60601-1 Testing and Certification
We support you in the testing and certification of your medical devices and systems according to national and international standards and regulations, e.g. by application of IEC 60601 series
- 4-6 week typical lead time
- ISO 17025 Accredited testing program
- IECEE CB Scheme testing and
- US-NRTL certification according to ANSI/AAMI ES60601- 1 and CAN/CSA-C22.2 No. 60601-1
- INMETRO certification for access to the Brazilian market
Medical Device Sterilisation Validation
We validate your medical device sterilisation instructions, which can be moist heat, low temperature hydrogen peroxide or other process.
- 4-5 week typical lead time
- Simulated use/accumulation study
- BS EN ISO 17664-1:2021
- ISO 14937:2009
- BS EN ISO 17665:2024
Medical Device Disinfection Validation
We validate your medical device disinfection instructions, as detailed in your IFU, which can be manual or automated.
- 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
UV-C Technology Efficacy Testing
We assess the efficacy of UV-C light technology units and systems against the latest industry standards.
- 2-4 week typical lead time
- BS8628:2023 – UKAS accredited
- 245nm UV-C, UVC LED, Far UVC (222nm)
- Safety and Output Measurement testing
- Simulated real-world use studies/ worst case studies
Label Durability Validation
We perform assessments of medical device packaging, labels and markings to determine the robustness during the life cycle of the device.
- 2-4 week typical lead time
- Finished Product Testing
- Bulk Product/Batch Testing
- Life Cycle Testing
- Verification Testing
Highly Accelerated Life Test
We use in-house methods and technologies to repeatedly operate devices and prototypes without human intervention to provide crucial data in accelerated time.
- 4-6 week typical lead time
- Medical device expected service life testing
- Material compatibility testing
- Basic electrical safety & essential performance testing
- Final product & prototype testing
Medical Device Cleaning Validation
We validate your medical device cleaning instructions, as detailed in your IFU, which can be manual or automated.
- 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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