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Test Labs Ltd
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  5. Medical Device Cleaning Validation ...

Medical Device Cleaning Validation Service

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Test Labs Ltd provides a Medical Device Cleaning Validation service that ensures medical device cleaning protocols, as specified in the Instructions for Use (IFU), are accurately validated. This service is applicable to both manual and automated cleaning methods and complies with international standards such as ISO 17664, ISO 15883, ANSI/AAMI ST98, and ASTM F3208. It involves the use of appropriate test soils and residual analytes, like proteins and carbohydrates, to detect potential contaminants. The company offers industry-leading turnaround times, generally within a 2-4 week period, ensuring the timely validation of medical device cleaning processes. The validation process is crucial for the safety and efficacy of reprocessed medical devices and aims to deliver reliable data, facilitating compliance with healthcare regulations and standards. Test Labs Ltd is equipped with specialized laboratories for microbiological and chemical testing to support the process.
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  • Edinburgh soil - For use with instruments used in general surgery, orthopaedic and upper respiratory.
  • Dental soil - For use with instruments used in dentistry.
  • Ophthalmic soil - For use with instruments used in eye procedures.
  • Artificial Test Soil - For use with instruments used in gastrointestinal procedures.
  • Blood soil - For use with instruments used in general surgery.
  • This is not an exhaustive list, depending on your medical device application, alternative test soils can be selected.
  • As per standards, two analytes must be picked for the cleaning validation study. The minimum requirement is Protein and one of the following residual analytes: Haemoglobin; ATP; Carbohydrates; TOC; Endotoxin.
  • BS EN ISO 17664-1:2021 - Processing of health care products. Information to be provided by the medical device manufacturer for the processing of medical devices. Critical and semi-critical medical devices
  • BS EN ISO 15883-1:2009+A1:2014 - Washer-disinfectors. General requirements, terms and definitions and tests
  • BS EN 15883-5:2021 - Washer-disinfectors. Performance requirements and test method criteria for demonstrating cleaning efficacy
  • ANSI/AAMI ST98:2022 - Cleaning validation of health care products - Requirements for development and validation of a cleaning process for medical devices
  • ASTM F3208-20 - Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices

We offer testing services to ensure the cleaning instructions outlined in your Medical Device Instructions for Use (IFU) have been fully validate. As outlined in the ISO 17664 Processing of health care products: Information to be provided by the medical device manufacturer for the processing of medical devices (part 1 Critical and semi-critical medical devices, and part 2 Non-critical medical devices), all Medical Devices manufactures are responsible to provide instruction of use when reprocessing of the device is intended. These instruction shall be fully validated to ensure safety of the device. Both manual and automated (Washer disinfector) processes shall be validated as per ISO 17664.