Services available for Thermal Disinfection
Clinical Evaluation
We develop and implement a methodologically sound procedure to collect, appraise, and analyse clinical data pertaining to your medical device.
- 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
Medical Device Biocompatibility Testing
We offer tests which evaluate cytotoxicity and biological risks within the chemical make-up of a medical device.
- 4-5 week typical lead time
- Biological Evaluation Plan & Report
- In Vitro & In Vivo methods
- Extractables & Leachables (E&L) Studies
- Also testing after cleaning, disinfection & sterilization
Medical Device Material Compatibility Testing
We analyse test item materials at both sample and product level to assess process compatibility.
- 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
Pre-compliance IEC 60601-1 Testing
We test your device, mitigating the cost of repeated compliance testing by evaluating potential non- compliances.
- 2-3 week typical lead time
- Documentation review
- Critical Component and Insulation Review
- Laboratory Testing
- HALT
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
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
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
Medical Device Biological Evaluation Report
We produce a report which is a collective summary of all data used to assess the biocompatibility of your medical device.
- 2-3 week typical lead time
- ISO 10993-1 – Biological evaluation of medical devices
- Meets the requirements of FDA / MDR
- Provides comprehensive ISO10993 report
- Completed by in-house toxicologist (competent person)
ISO 10993-5 Cytotoxicity Testing
We offer ISO 10993-5 cytotoxicity in vitro tests which evaluate biological risks within the chemical make-up of a medical device.
- 2-4 week typical lead time
- Offered as Good Laboratory Practice GLP study
- Biological Evaluation Plan
- Biological Evaluation Report
- ISO 10993-5 – cytotoxicity – in vitro methods
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 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
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
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
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