Cleaning Validation

What Is Cleaning Validation?

Cleaning validation proves that the manufacturer's cleaning instructions for a reusable medical device reduce real-use soiling to an acceptable level. It is a mandatory step before sterilisation: a device with organic residue on it cannot be reliably sterilised.

Purpose of Cleaning Validation

The purpose is to show that the cleaning method in the instructions for use is effective even in the worst-case soiling scenario, and to fulfil the information obligation under ISO 17664.

Which Products Is Cleaning Validation Applied To?

Reusable surgical instruments
Endoscopes and lumened devices
Orthopaedic instruments and sets
Dental hand instruments
Reusable device accessories

In Which Sectors Is Cleaning Validation Used?

Medical DeviceHealthcarePharmaceuticals

Standards Related to Cleaning Validation

ISO 17664-1
ISO 15883 series
AAMI TIR30
AAMI ST98
ISO 11737-1determination of microbial load in medical devices test
ISO 11607end product sterile barrier packaging test

Cleaning Validation Conditions

Test soil: Artificial soil representing clinical use, as defined in the standards, is applied
Worst case: The hardest-to-clean points of the device (lumen, hinge, blind hole) are targeted
Markers: Residue indicators such as protein, haemoglobin, TOC, carbohydrate and endotoxin are measured

Equipment for Cleaning Validation

Washer-disinfector
Ultrasonic cleaner
Residue-extraction rig
Spectrophotometer and TOC analyser
Microbiology laboratory infrastructure

Sample Requirements for Cleaning Validation

Real devices, in a configuration representing the worst case
The number of specimens must be determined with statistical justification
Device design details (lumen diameter, hinge, disassembly) must be shared
The recommended cleaning instructions and chemicals must be provided

Duration of Cleaning Validation

Typically several weeks, including method development and repeat cycles.

Cleaning Validation Procedure

1The device's hardest-to-clean points are identified.
2The residue-extraction method is developed and recovery efficiency is determined.
3The test soil defined in the standard is applied to the device and left to dry.
4The cleaning cycle in the manufacturer's instructions is applied.
5Residues are extracted from the device.
6Protein, haemoglobin, TOC and other markers are measured.
7The residue level is calculated, corrected by the recovery factor.
8The cycle is repeated to demonstrate consistency.

Cleaning Validation Acceptance Criteria

Acceptance criteria are determined and justified by the organisation; residue thresholds commonly used in technical reports such as AAMI TIR30 (e.g. values on the order of micrograms per unit area for protein) are used as reference. The standard does not impose a single universal limit.

Evaluation of Results

Results are evaluated at the worst-case points. If recovery efficiency is low, the measured residue appears lower than it really is; validation of the extraction method is therefore essential for the reliability of the result.

Cleaning Validation Report

Device description and worst-case rationale
Test-soil composition and application method
Cleaning-cycle parameters
Extraction method and recovery efficiency
Residue-marker results
Acceptance criteria and rationale

Accreditation

EUROLAB holds internationally recognised accreditation obtained from accreditation bodies party to the IAF and ILAC multilateral recognition arrangements, under ISO/IEC 17025 for laboratory testing, ISO/IEC 17020 for inspection and surveillance, and ISO/IEC 17021-1 and ISO/IEC 17065 for system and product certification. This chain ensures the reports and certificates issued are accepted worldwide.

Whether this test can be offered within accredited scope depends on your product and the standard applied; since accreditation is method-based, the scope is confirmed in writing at the quotation stage.

Scope and authorisations

Related Regulations

MDR (EU) 2017/745
ISO 17664 information requirements

Medikal Cihaz Testleri — What Does This Testing Field Cover?

The section below describes the field that the Cleaning Validation test belongs to; the conditions and acceptance criteria of this particular test are given in the sections above. The scope specific to your product is confirmed in writing at the quotation stage.

Medical device testing shows that a device is safe for the patient and the user and maintains its intended performance. In this family safety is not only about avoiding harm; a device failing to perform its expected function is also treated as a risk. A monitor missing an alarm or a pump delivering the wrong dose is directly a patient safety event.

At the centre of the field is RISK MANAGEMENT, and this is what sets medical apart from other sectors. The risk management process run under ISO 14971 also determines which tests are required. The test list is not copied from a table of standards; it is derived and justified from the device's intended use, the nature and duration of patient contact, the use environment and foreseeable misuse.

Assessment consists of several separate bodies of work, each with its own set of standards. Biocompatibility runs through the ISO 10993 series, electrical device safety through the IEC 60601 series, sterilisation through ISO 11135/11137/17665, packaging through ISO 11607, software through IEC 62304 and usability through IEC 62366. The quality system (ISO 13485) is the framework that binds these together.

Which tests are required is determined by the device's CLASS and its MODE OF CONTACT WITH THE BODY. A product in brief contact with skin and an implant entering the bloodstream do not go through the same test set; the scope is set by a biological evaluation plan prepared under ISO 10993-1. That plan justifies in writing which endpoints are required and why the others are not.

Packaging and sterilisation are taken as seriously as the device itself in this field. For a sterile device the packaging is not a transport container but the barrier that maintains sterility; if the barrier is breached, the device is no longer sterile. Packaging processes are therefore validated and shelf life is supported by real-time ageing data.

For devices containing software, assessment shifts from testing towards PROCESS assurance. IEC 62304 defines which development and verification steps must be followed according to the safety class of the software; the evidence is the traceability of the development process. Testing software does not make it safe — the process record does.

The clinical side is a separate column of the technical file. Test reports show that the device is technically safe; clinical evaluation establishes that the device delivers the intended clinical benefit and that the benefit-risk balance is acceptable. Neither replaces the other.

Method groups in this field

Biocompatibility
Cytotoxicity, irritation, skin sensitisation, systemic toxicity, haemocompatibility, genotoxicity and local effects after implantation. The required endpoints are set by the ISO 10993-1 plan.
Electrical device safety
IEC 60601-1 basic safety and essential performance; EMC, alarm, usability and environmental requirements through the collateral standards.
Sterilisation validation
Validation of sterilisation processes by ethylene oxide, radiation or moist heat; bioburden and sterility assurance level studies.
Packaging
Integrity of the sterile barrier system, seal strength, distribution simulation and shelf-life studies.
Microbiological tests
Bioburden determination, sterility testing, bacterial endotoxin and, where required, carrier validation studies.
Software and usability
IEC 62304 life cycle evidence and use-error focused evaluation under IEC 62366.

Commonly confused in this field

Cytotoxicity alone is not evidence of biocompatibility; the required set of endpoints is determined and justified according to ISO 10993-1.
An ISO 13485 certificate does not confer CE marking; classification under the MDR, the technical file and the notified body process run separately.
Accelerated ageing does not replace real-time ageing; a shelf life claim is supported by real-time data.
A change of material (supplier, pigment, sterilisation method) may require the biological evaluation to be repeated; it is not a silent change.
An assessment made without the collateral and particular standards for IEC 60601-1 is incomplete; which -1-x and -2-x standards were applied must appear in the report.
In vitro diagnostic devices fall under the IVDR rather than the MDR, and laboratory equipment is often on the IEC 61010-1 side.

Which decisions these results support

MDR/IVDR technical file and notified body assessment
Completing the biological evaluation plan
Sterilisation and packaging validation
Determining shelf life and storage conditions
Determining the scope of reassessment after a design change

Related Tests

Frequently Asked Questions About Cleaning Validation

Why is a worst-case device selected?

Validating every device in a product family separately is impractical. If the hardest-to-clean geometry (the narrowest lumen, the most complex hinge) is validated, the more easily cleaned members of the family are also covered. The selection must be justified.

Does cleaning validation substitute for sterilisation validation?

No; the two are sequential steps. Cleaning is a precondition for sterilisation to be effective. Organic residue protects microorganisms from the sterilant; both must therefore be validated separately.