Reprocessing Validation For Class 1r Medical Devices

We test your medical device reprocessing procedures, as detailed in your IFU, validating the cleaning, disinfection and sterilisation cycles.

Reprocessing refers to a process carried out on a used device in order to allow its safe reuse. It includes its cleaning, disinfection, sterilisation and related procedures, as well as testing and restoring the technical and functional safety of the used device.

At Test Labs, we offer testing services to ensure the reprocessing instructions outlined in your Instructions for Use (IFU) are fully validated. Validation of reprocessing follows the principles and guidelines described in BS EN ISO 17664-1 (critical and semi-critical MD) and BS EN ISO 17664-2 (non-critical MD).

The introduction of new requirements from the MDR for Class Ir Medical Devices has added an extra level of complexity for manufacturers to comply with the regulations. Self-certification will not the allowed for Class Ir, and therefore a Notified Body will be required to review the technical file. Specific attention will be given to the performance requirements of specific intended use, in this case reprocessing. Full validation of the reprocessing cycles included in the IFU needs to be included.

Technical file requirements for Class Ir: Everything you need to know

MDR requires a clear, organized, searchable, and unambiguous technical file presentation

HTM 01-01: Management and decontamination of surgical instruments used in acute care

HTM 01-01 consists of a list of documents that provide guidance and information on the decontamination and reprocessing of reusabl...

Dental Product Material Compatibility Testing – Case study

Medical device safety testing includes material compatibility studies with wide range of quantitative measurements

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Clinical Evaluation

We develop and implement procedures to collect, appraise, and analyse clinical data pertaining to your medical device.

Medical devices bioburden testing

Our team will determine the presence or absence of bioburden on your sterile or non- sterile medical devices.

Disinfection products for medical devices

We test the efficacy of a wide range of disinfectants for medical devices, including disinfection technologies and robots.

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Microbiology Laboratory

We are fully equipped to perform a wide variety of microbiology tests using bacteria, yeast, fungi, and bacterial spores.

Test chambers

We have built state of the art Test Chambers – all with a stainless steel interior and equipped with a wide range of sensors.

Chemistry Laboratory

Our chemistry lab is fully equipped to perform a wide variety of tests, that supports formulation and materials

Strong foundations are built with robust Quality Management Systems