Updated: 9th September 2026
Reviewed by: David Small BSc (Hons), MSc, MTOPRA (Founder and CEO)
What Is Medical Device Cleaning Validation?
Medical device cleaning validation is the documented process of demonstrating that a defined cleaning procedure can consistently reduce contaminants and residues to predetermined acceptable levels.
Cleaning can be critical to medical device safety. Residues remaining on a device may include manufacturing contaminants, processing chemicals, cleaning agents, biological material or other substances that could affect biological safety, device performance or subsequent processing such as disinfection and sterilisation.
A cleaning validation programme should therefore establish objective evidence that the specified cleaning process is effective, reproducible and appropriate for the device under the conditions in which it will actually be performed.
Depending on the device, cleaning validation may need to consider:
- the types and levels of contamination that may be present
- device materials and surface characteristics
- joints, lumens, recesses and other difficult-to-clean features
- cleaning agents and process chemicals
- cleaning temperature, concentration, time and mechanical action
- manual or automated cleaning processes
- rinsing and drying
- residual cleaning agents
- microbiological contamination where relevant
- worst-case device configurations
- repeated cleaning and reprocessing cycles
- the effect of cleaning on device safety and performance
- acceptance criteria and analytical test methods
The validation should reflect the actual device, cleaning process and reasonably foreseeable worst-case conditions rather than simply demonstrating that a device appears visually clean.
Cleaning Is Not the Same as Sterilisation
Cleaning, disinfection and sterilisation are related but distinct processes.
Cleaning removes contamination and residues from a medical device. Disinfection reduces viable microorganisms to a level appropriate for the intended use, while sterilisation uses a validated process to render a product free from viable microorganisms to the required level of assurance.
For reusable devices, effective cleaning can be essential before subsequent disinfection or sterilisation. A sterilisation process should not be relied upon to compensate for an inadequately cleaned device.
Need an Introduction to Medical Device Validation?
This article focuses on cleaning validation for medical devices. If you're looking for a complete overview of medical device validation, including cleaning, packaging, sterilization, electrical safety, transport validation and regulatory requirements, read our Complete Guide to Medical Device Validation.
Why Is Medical Device Cleaning Validation Required?
Manufacturers must demonstrate that their medical devices remain safe and perform as intended throughout their specified lifecycle.
Where cleanliness is necessary for device safety or performance, manufacturers need appropriate evidence that the cleaning process is capable of achieving the required result consistently.
Cleaning validation can be particularly important where:
- manufacturing residues could remain on the finished device
- processing chemicals or lubricants are used during manufacture
- a device is supplied non-sterile but requires cleaning before use
- a reusable device is cleaned between patient uses
- contamination could interfere with subsequent disinfection or sterilisation
- the device contains difficult-to-clean features such as lumens, hinges or textured surfaces
- residual contamination could create a biological or toxicological risk
- cleaning forms part of a validated reprocessing procedure
For reusable critical and semi-critical medical devices, ISO 17664-1:2021 specifically addresses the processing information manufacturers must provide, covering activities such as preparation before cleaning, cleaning, disinfection, drying, inspection, packaging and sterilisation where applicable.
Cleaning validation should therefore be considered as part of the manufacturer’s wider approach to risk management, verification and validation and technical documentation.
Manufacturing Cleaning vs Reusable Medical Device Cleaning
One distinction that is often overlooked is that medical device cleaning validation can apply at different stages of the device lifecycle.
Manufacturing Cleaning
Cleaning may be required during manufacture to remove contaminants introduced by production activities.
These can include:
- machining oils and lubricants
- mould-release agents
- polishing compounds
- particulate contamination
- processing chemicals
- adhesives or other manufacturing residues
- cleaning-agent residues
- environmental contamination
The manufacturer should identify which contaminants could reasonably be present, determine whether they could affect device safety or performance and establish appropriate cleanliness requirements.
The resulting validation should demonstrate that the manufacturing cleaning process consistently achieves those requirements.
Cleaning of Reusable Medical Devices
Reusable devices present a different challenge because contamination occurs during clinical use and the device must subsequently be capable of being safely reprocessed.
The manufacturer needs to consider the complete reprocessing sequence and provide appropriate processing information. ISO 17664-1:2021 applies to processing information for critical and semi-critical devices and devices intended to be sterilised, while ISO 17664-2:2021 addresses non-critical medical devices.
Validation may therefore need to consider:
- contamination representative of clinical use
- time between use and cleaning
- pre-treatment at the point of use
- device disassembly
- manual cleaning steps
- automated cleaning
- cleaning-agent concentration
- water quality
- temperature and exposure time
- brushing, flushing or other mechanical action
- rinsing
- drying
- inspection
- repeated reprocessing cycles
- maximum claimed device lifetime
The validated procedure should support the processing instructions supplied with the device.
Important Distinction
A successful cleaning validation is not simply evidence that a particular set of samples were clean after testing.
It should demonstrate that the defined cleaning process is capable of consistently achieving predetermined cleanliness requirements when operated within its specified parameters, including appropriate worst-case conditions.
Regulatory Requirements for Medical Device Cleaning Validation
Cleaning validation should not be treated as an isolated laboratory exercise. The need for cleaning, the level of validation required and the evidence generated should be linked to the applicable regulatory requirements, the device’s intended purpose and the risks associated with inadequate cleaning.
For manufacturers placing devices on the EU or Great Britain markets, cleaning requirements may arise from the general safety and performance or essential requirements applying to the device, as well as from the manufacturer’s Quality Management System and risk management processes.
EU MDR Requirements for Cleaning Validation
Regulation (EU) 2017/745 requires devices to be designed and manufactured so that they are safe and perform as intended throughout their lifecycle.
Cleaning becomes particularly important where contamination could compromise the safety or performance of the device, or where a device is intended to be reused.
For reusable devices, Annex I, Section 23.4(n) of the EU MDR requires the Instructions for Use to provide information on the appropriate processes that allow reuse, including cleaning, disinfection, packaging and, where appropriate, the validated method of re-sterilisation. Manufacturers must also provide information enabling users to determine when the device should no longer be reused, such as signs of degradation or a maximum number of permitted reuses.
The manufacturer’s validation evidence should therefore support the cleaning and reprocessing instructions supplied with the device.
Depending on the device, the Technical Documentation may need to demonstrate:
- how contamination-related hazards have been identified
- how the required level of cleanliness has been established
- that the specified cleaning procedure can achieve that level
- that appropriate worst-case conditions have been evaluated
- that cleaning does not adversely affect device safety or performance
- that reusable devices remain suitable throughout the claimed number of reprocessing cycles
- that the validated procedure supports the Instructions for Use
Cleaning validation evidence should form part of the wider verification and validation evidence demonstrating conformity with the applicable General Safety and Performance Requirements.
Need an Introduction to the EU Medical Device Regulation?
Cleaning validation forms part of the wider evidence manufacturers may need to demonstrate the safety and performance of their medical devices under the EU MDR. If you're looking for a broader overview of device classification, GSPRs, Technical Documentation, verification and validation, CE marking and post-market requirements, read our Complete Guide to the EU Medical Device Regulation .
UK MDR Requirements for Cleaning Validation
Medical devices placed on the Great Britain market must meet the applicable Essential Requirements of the UK Medical Devices Regulations 2002.
Manufacturers are responsible for determining which Essential Requirements apply to their device and maintaining evidence demonstrating conformity. Relevant designated standards may be used to support this demonstration where appropriate.
Where cleaning is necessary to maintain device safety, performance or appropriate infection control, the manufacturer should establish suitable requirements and generate evidence demonstrating that the specified cleaning process is effective.
For reusable devices, this also means that the manufacturer’s instructions should provide sufficient information for the device to be safely decontaminated and reused in accordance with its intended purpose.
Need an Introduction to UK Medical Device Regulations?
Cleaning validation may form part of the evidence needed to demonstrate that a medical device meets the applicable requirements in Great Britain. If you're looking for a broader overview of the UK MDR, UKCA marking, MHRA registration, Technical Documentation, verification and validation and post-market requirements, read our Complete Guide to UK Medical Device Regulations .
ISO 13485 and Cleaning Validation
ISO 13485 provides the Quality Management System framework within which cleaning processes and their validation should be controlled.
Where the outcome of a production or service process cannot be fully verified by subsequent monitoring or measurement, the process must be validated to demonstrate its ability to achieve planned results consistently.
For a cleaning process, the QMS should therefore address, as applicable:
- defined responsibilities
- approved cleaning procedures
- equipment qualification
- process parameters
- personnel competence and training
- validation protocols
- predefined acceptance criteria
- monitoring and measurement
- validation records
- equipment maintenance and calibration
- control of changes
- evaluation of deviations
- revalidation requirements
The extent of these controls should be proportionate to the device, cleaning process and associated risks.
Need an Introduction to ISO 13485?
Cleaning processes and their validation should be appropriately controlled within the manufacturer's Quality Management System. If you're looking for a broader overview of process validation, design controls, risk management, documentation, CAPA and other medical device QMS requirements, read our Complete Guide to ISO 13485 .
ISO 14971 and Cleaning-Related Risk Management
Cleaning validation should be closely connected to the manufacturer’s medical device risk management process.
ISO 14971 establishes a lifecycle framework for identifying hazards, estimating and evaluating risks, implementing risk controls and monitoring their effectiveness.
The risk assessment should consider what could happen if the device is not adequately cleaned.
Potential cleaning-related hazards may include:
- residual biological contamination
- microbial contamination
- manufacturing residues
- detergent or cleaning-agent residues
- particulate contamination
- chemical residues
- cross-contamination
- interference with subsequent sterilisation
- material degradation caused by repeated cleaning
- deterioration in device performance
- inadequate cleaning of difficult-to-access areas
Risk management should then help determine the level of validation required, appropriate acceptance criteria and the worst-case conditions that need to be challenged.
Importantly, the validation results should also provide evidence that cleaning-related risk controls are effective.
Need an Introduction to ISO 14971 Risk Management?
Risk management should help determine the cleaning requirements, acceptance criteria, worst-case conditions and level of validation evidence required for a medical device. If you're looking for a broader overview of hazard identification, risk analysis, risk controls, residual risk and lifecycle monitoring, read our Complete Guide to ISO 14971 Risk Management .
Standards Applicable to Medical Device Cleaning Validation
There is no single standard that applies to every medical device cleaning validation. The appropriate standards depend on factors such as the intended purpose of the device, whether it is reusable, the type of patient contact, the cleaning method and whether cleaning is performed manually or using automated equipment.
Manufacturers should therefore determine which standards are applicable as part of their regulatory and risk management assessment rather than applying the same validation approach to every device.
ISO 17664-1 – Processing of Critical and Semi-Critical Medical Devices
ISO 17664-1:2021 specifies requirements for the processing information that manufacturers must provide for critical and semi-critical medical devices and devices intended to be sterilised.
The standard addresses the information manufacturers should provide for applicable processing activities including:
- initial treatment at the point of use
- preparation before cleaning
- cleaning
- disinfection
- drying
- inspection and maintenance
- packaging
- sterilisation
- storage
- transportation
The manufacturer’s processing instructions should be supported by appropriate evidence demonstrating that the specified processes can be effectively performed on the device.
ISO 17664-1:2021 remains the published edition as of September 2026, although it is currently undergoing systematic review.
ISO 17664-2 – Processing of Non-Critical Medical Devices
ISO 17664-2:2021 applies to processing information for non-critical medical devices that are not intended to be sterilised.
This generally includes devices intended to contact intact skin only or devices that do not directly contact the patient.
Where applicable, processing information can include:
- preparation before processing
- cleaning
- disinfection
- drying
- inspection and maintenance
- packaging
- storage
- transportation
The standard complements ISO 17664-1 by addressing devices presenting a different level of processing risk.
ISO/TS 17664-3:2026 – Cleaning Classification of Reusable Medical Devices
A significant recent addition to the ISO 17664 series is ISO/TS 17664-3:2026, published in June 2026.
This Technical Specification provides guidance for assigning reusable medical devices to cleaning classification categories. It considers attributes including device design, materials and intended use and provides a framework for grouping devices into product families and associating those families with appropriate cleaning processes.
This can be particularly useful when a manufacturer has a family of similar reusable devices and needs to determine which device represents an appropriate master or worst-case product for cleaning validation.
Rather than validating every device configuration independently, a scientifically justified grouping strategy may allow representative devices to be selected for validation.
However, the manufacturer should document why the selected device adequately challenges the cleaning process and represents the other devices within the defined product family.
ISO 15883 – Automated Washer-Disinfectors
Where reusable medical devices are intended to be processed using washer-disinfectors, the ISO 15883 series may also be relevant.
The series addresses washer-disinfector performance, cleaning and disinfection, validation, routine monitoring and requalification.
For example, ISO 15883-1:2024 establishes general requirements for washer-disinfectors and specifies requirements relating to validation, routine control, monitoring and requalification.
Other parts address particular applications. ISO 15883-2:2024, for example, covers washer-disinfectors using thermal disinfection for reusable critical and semi-critical medical devices.
The precise part of ISO 15883 that applies therefore depends on the equipment, device and intended cleaning and disinfection process.
ISO 15883-5 and Cleaning Efficacy
ISO 15883-5:2021 provides performance requirements and test-method criteria for demonstrating the cleaning efficacy of washer-disinfectors.
It addresses areas such as test soils and methods used to assess cleaning performance. However, its scope is important: ISO states that the standard applies to demonstrating washer-disinfector cleaning efficacy and does not apply directly to the activities performed by reusable medical device manufacturers.
Manufacturers should therefore avoid treating compliance with ISO 15883-5 as a substitute for demonstrating that their own device can be effectively cleaned according to the processing instructions they provide.
What Contaminants Should Cleaning Validation Address?
Before developing a cleaning validation study, the manufacturer needs to understand what the cleaning process is actually intended to remove.
The relevant contaminants will depend heavily on whether the cleaning process occurs during manufacturing or following clinical use.
Manufacturing Residues
Manufacturing processes can introduce substances that may remain on the finished device.
Depending on the manufacturing process, these could include:
- machining oils
- lubricants
- polishing compounds
- mould-release agents
- adhesives
- processing chemicals
- particulate contamination
- metalworking fluids
- detergents
- cleaning-agent residues
- residues introduced during handling or assembly
The manufacturer should identify reasonably foreseeable residues rather than simply testing for a generic measure of cleanliness.
The potential effect of each residue on biological safety, device performance and subsequent processing should also be considered.
Clinical Contamination
For reusable medical devices, validation needs to represent contamination that could reasonably occur during clinical use.
Depending on the intended purpose and anatomical contact, this could include:
- blood
- proteins
- tissue
- mucus
- fats
- carbohydrates
- other organic material
- microorganisms
- combinations of clinically relevant soils
The challenge used during validation should be representative of the contamination expected during actual use and sufficiently challenging to demonstrate the effectiveness of the proposed cleaning procedure.
Cleaning-Agent Residues
Cleaning itself can introduce substances that need to be adequately removed.
Detergents, enzymatic cleaners and other process chemicals may leave residues on the device if rinsing is inadequate.
Validation may therefore need to demonstrate both that the original contamination has been removed and that the cleaning process itself does not leave unacceptable chemical residues.
This should also connect back to the manufacturer’s biological safety and risk management assessments, particularly where residual chemicals could subsequently contact the patient.
Difficult-to-Clean Device Features
The physical design of the device can significantly affect cleaning effectiveness.
Particular consideration should be given to features such as:
- narrow lumens
- blind holes
- hinges
- joints
- threads
- textured surfaces
- porous materials
- overlapping components
- channels
- crevices
- inaccessible internal surfaces
- devices requiring disassembly before cleaning
These features can influence both the selection of the worst-case device and the locations from which residual contamination should be assessed.
A device that appears clean externally may still contain unacceptable contamination within a lumen, joint or other difficult-to-access area.
Need More Guidance on Biological Evaluation?
Residual manufacturing chemicals, cleaning agents and other contaminants may need to be considered as part of the biological safety assessment of a medical device. Learn how biological risks are identified, evaluated and documented using the ISO 10993 framework in our Complete Guide to Biological Evaluation of Medical Devices .
How to Develop a Medical Device Cleaning Validation Strategy
A cleaning validation strategy should be developed before testing begins. The objective is to establish a scientifically justified approach that demonstrates the cleaning process can consistently achieve the required level of cleanliness under defined and appropriately challenging conditions.
The strategy should be based on the device’s intended purpose, design, materials, contamination risks, cleaning method and applicable regulatory requirements.
A typical cleaning validation strategy can be developed through the following steps.
Step 1 – Define the Device and Cleaning Process
The manufacturer should first clearly define what is being validated.
This should include, as applicable:
- device or device family
- intended purpose
- patient-contacting materials and surfaces
- reusable or single-use status
- device configuration
- areas requiring cleaning
- manufacturing or clinical contaminants
- cleaning equipment
- cleaning agents
- water quality
- cleaning temperature
- cleaning-agent concentration
- exposure time
- mechanical action
- rinsing
- drying
- device disassembly and reassembly
- subsequent disinfection or sterilisation
The validation should reflect the cleaning procedure that will actually be used during manufacture or specified in the device’s reprocessing instructions.
Step 2 – Identify Cleaning-Related Risks
The cleaning validation strategy should be linked to the manufacturer’s risk management process.
The manufacturer should consider what could happen if the cleaning process is ineffective or incorrectly performed.
For example:
Inadequate cleaning
↓
Residual contamination
↓
Patient exposure or interference with subsequent processing
↓
Potential biological, infection or performance risk
↓
Cleaning requirements and risk controls
↓
Cleaning validation
This creates traceability between the identified risk, the required cleaning performance and the evidence generated during validation.
Step 3 – Identify the Relevant Contaminants or Test Soil
The validation challenge should represent the substances that the cleaning process is intended to remove.
For manufacturing cleaning, this may involve actual or simulated manufacturing residues such as oils, lubricants, polishing compounds or processing chemicals.
For reusable devices, an appropriate test soil may be required to simulate clinically relevant contamination.
The selected soil or contaminant should:
- represent the expected contamination
- challenge the proposed cleaning process appropriately
- be suitable for the device and intended use
- allow cleaning effectiveness to be measured
- be scientifically justified
A convenient or easily measured test soil should not be selected simply because it produces favourable validation results.
Step 4 – Select the Worst-Case Device or Configuration
Where multiple devices, sizes or configurations are covered by the same cleaning process, it may not be necessary to validate every individual product.
However, the manufacturer should establish a documented rationale for selecting the device or configuration that provides an appropriate cleaning challenge.
Factors that can influence worst-case selection include:
- longest or narrowest lumen
- most complex internal geometry
- greatest number of joints or hinges
- largest surface area
- rough or textured surfaces
- difficult-to-access locations
- materials to which contamination adheres more readily
- devices requiring complex disassembly
- highest expected contamination
- most challenging cleaning-agent compatibility
- lowest flow or flushing conditions
The selected worst case should be based on characteristics that genuinely affect cleaning rather than simply selecting the largest device in the product family.
Where a product-family approach is used, the rationale for representing the other devices should be documented.
Step 5 – Define Worst-Case Cleaning Conditions
Validation should challenge the cleaning process under appropriately adverse conditions within the manufacturer’s claimed operating parameters.
Depending on the process, this might include:
- minimum cleaning time
- minimum permitted temperature
- lowest cleaning-agent concentration
- maximum permitted contamination
- maximum delay between use and cleaning
- minimum rinse time
- challenging water conditions
- difficult device orientation
- maximum load in automated equipment
- minimum mechanical action
- maximum number of reuse cycles
Not every parameter should automatically be set to an extreme value. The manufacturer should determine which parameters could meaningfully affect cleaning performance and establish scientifically justified worst-case conditions.
Establishing Cleaning Validation Acceptance Criteria
Acceptance criteria are fundamental to a defensible cleaning validation.
They should be established before validation testing is performed and should define what constitutes an acceptable cleaning result.
Simply stating that a device must be “clean” is generally insufficient.
How Should Cleaning Acceptance Limits Be Established?
There is no single universal acceptance limit that applies to every medical device.
Acceptance criteria should be justified based on factors such as:
- intended purpose
- nature of the contaminant
- patient contact
- biological and toxicological risk
- device design
- subsequent processing
- applicable standards or guidance
- analytical capability
- established product specifications
- available scientific evidence
Different contaminants may therefore require different acceptance criteria.
For reusable devices, acceptance criteria may also need to reflect clinically relevant residual contamination following the validated cleaning procedure.
Visual Cleanliness
Visual inspection can form part of a cleaning validation but should not automatically be considered sufficient evidence on its own.
Visual examination may identify:
- visible soil
- staining
- particulate contamination
- residues
- incomplete cleaning of accessible surfaces
However, contamination can remain at levels that are not visible to the naked eye, particularly within lumens, joints and other inaccessible areas.
Where clinically or toxicologically significant residues cannot be adequately assessed visually, an appropriate analytical method should be used.
Quantitative Acceptance Criteria
Depending on the device and contamination being assessed, quantitative testing may include measurement of:
- protein residues
- haemoglobin
- total organic carbon
- carbohydrates
- lipids
- detergent residues
- specific chemical residues
- particulate contamination
- other relevant analytes
The test selected should be appropriate for the contaminant and capable of detecting residues at levels relevant to the established acceptance criterion.
The manufacturer should document the scientific basis for both the selected test method and the acceptance limit.
Selecting Cleaning Validation Test Methods
The analytical method used to evaluate cleaning effectiveness is just as important as the cleaning procedure itself.
A test method that cannot reliably recover or detect the relevant residue may give the appearance of successful cleaning even when contamination remains on the device.
Analytical Method Suitability
The manufacturer should establish that the analytical method is suitable for its intended purpose.
Depending on the method and validation strategy, relevant characteristics may include:
- specificity
- sensitivity
- limit of detection
- limit of quantification
- accuracy
- precision
- repeatability
- linearity
- analytical range
- robustness
The extent of analytical method validation or verification required should be proportionate to the method, its intended use and the risk associated with the measurement.
Extraction and Recovery Efficiency
For many cleaning validation studies, residues must first be extracted from the medical device before they can be measured.
The extraction method might involve:
- rinsing
- flushing
- swabbing
- immersion
- agitation
- sonication
- a combination of techniques
The manufacturer should demonstrate that the chosen method can adequately recover the contaminant from the relevant device surfaces.
This is particularly important for complex devices containing lumens, joints, recesses or other difficult-to-access areas.
A low analytical result is not meaningful if the extraction procedure itself is unable to recover the contamination present.
Recovery Studies
Recovery studies can be used to determine how effectively the selected extraction and analytical method recovers a known quantity of contaminant from the device or representative material.
A known challenge can be applied to the relevant surface and subsequently recovered using the proposed extraction procedure.
This helps establish whether the analytical result provides a reasonable representation of the residue actually remaining on the device.
Where recovery is incomplete, the manufacturer should determine how this will be addressed when interpreting the validation results.
Developing a Medical Device Cleaning Validation Protocol
Once the cleaning validation strategy has been established, the manufacturer should document how the validation study will be performed in an approved protocol.
The protocol should be sufficiently detailed to allow the study to be performed consistently and to demonstrate that the test conditions, methods and acceptance criteria were established before testing began.
A cleaning validation protocol should typically define:
- purpose and scope of the validation
- device or product family covered
- responsibilities
- cleaning procedure being validated
- applicable standards and procedures
- contaminants or test soils
- method of contamination
- device conditioning before cleaning
- worst-case device or configuration
- worst-case cleaning parameters
- number of samples and justification
- number of cleaning or reprocessing cycles
- cleaning equipment and materials
- analytical and inspection methods
- extraction and recovery methods
- predefined acceptance criteria
- treatment of deviations
- data recording requirements
- statistical methods, where appropriate
- requirements for review and approval
Any assumptions made during protocol development should be documented and scientifically justified.
Sample Size for Cleaning Validation
There is no universal number of samples that is appropriate for every medical device cleaning validation.
The sample size should be justified based on factors such as:
- device and process risk
- variability of the cleaning process
- complexity of the device
- variability between devices
- analytical method
- expected contamination
- applicable standards or guidance
- previous validation or development data
- statistical approach, where appropriate
Manufacturers should therefore avoid automatically adopting a particular sample number simply because it has been used in another validation.
The protocol should explain why the selected sample size provides sufficient evidence for the conclusions being drawn.
Preparing the Validation Samples
Samples should be prepared in a manner that appropriately challenges the cleaning process.
For reusable devices, this may involve applying a representative test soil to areas expected to become contaminated during clinical use.
Particular attention should be given to difficult-to-clean locations such as:
- lumens
- joints
- hinges
- crevices
- channels
- textured surfaces
- interfaces between components
- internal surfaces
Where appropriate, the contamination should be allowed to remain on the device for a defined period before cleaning to represent a clinically relevant delay between use and reprocessing.
The preparation method, quantity of challenge material and conditioning period should be controlled and documented.
Executing the Cleaning Process
The cleaning process used during validation should correspond to the process that will ultimately be specified by the manufacturer.
Critical parameters should be recorded during execution.
Depending on the process, these may include:
- cleaning time
- temperature
- detergent concentration
- water quality
- water volume or flow
- equipment settings
- brushing or flushing duration
- ultrasonic parameters
- rinse conditions
- drying conditions
- device orientation
- equipment load
- operator actions
Where worst-case parameters have been selected, the protocol should clearly identify them and explain why they represent an appropriate challenge.
Manual vs Automated Cleaning Validation
Medical devices may be cleaned manually, using automated equipment, or through a combination of both methods.
The validation approach should reflect how the manufacturer expects the device to be processed in practice.
Manual Cleaning Validation
Manual cleaning can introduce significant operator variability because effectiveness may depend on how individual steps are performed.
The procedure should therefore provide sufficiently detailed instructions covering matters such as:
- device preparation and disassembly
- cleaning-agent preparation
- water temperature
- soaking time
- brushing technique
- brush size or type
- number or duration of brush strokes where relevant
- flushing volumes or duration
- lumen cleaning
- rinsing
- visual inspection
- drying
- reassembly where applicable
Validation should challenge the procedure while still representing realistic use.
Where a particular technique, tool or duration is necessary to achieve acceptable cleaning, this should be clearly reflected in the manufacturer’s processing instructions.
Automated Cleaning Validation
Automated cleaning can provide greater process control, but the effectiveness of the process still needs to be demonstrated for the medical device concerned.
Relevant parameters may include:
- washer-disinfector programme
- cycle duration
- temperature
- detergent concentration
- water quality
- spray pressure or flow
- device positioning
- rack configuration
- equipment loading
- rinsing
- thermal disinfection where applicable
- drying
Where an ISO 15883 washer-disinfector is specified, the manufacturer should consider the applicable parts of the ISO 15883 series.
However, qualification or validation of the washer-disinfector itself does not automatically demonstrate that a particular medical device can be effectively cleaned within it. The device-specific cleaning instructions still require appropriate supporting evidence.
Cleaning Validation for Reusable Medical Devices
Reusable medical devices require particular consideration because the manufacturer is making a claim that the device can be safely processed and reused.
Validation should therefore consider not only whether a new device can be cleaned successfully, but whether the specified cleaning and reprocessing procedures remain effective throughout the claimed device lifetime.
Repeated Reprocessing and End-of-Life Validation
Repeated cleaning, disinfection and sterilisation can alter device materials and surfaces over time.
Potential changes can include:
- surface wear
- corrosion
- cracking
- deterioration of coatings
- degradation of seals
- changes to lumen surfaces
- increased surface roughness
- deterioration of joints or hinges
- reduced device functionality
These changes may affect both the ability to clean the device and its overall safety and performance.
Where the manufacturer claims a maximum number of reuse or reprocessing cycles, validation should consider whether the device remains capable of being effectively cleaned at the relevant end-of-life condition.
This may require devices to undergo repeated processing before the cleaning challenge is performed.
Validation of the Instructions for Use
For reusable devices, cleaning validation and the Instructions for Use should be closely aligned.
The validated cleaning process should support the instructions actually provided to the user.
The IFU should therefore accurately reflect relevant validated parameters such as:
- preparation immediately after use
- maximum delay before cleaning where applicable
- disassembly
- cleaning agents
- concentrations
- temperatures
- exposure times
- brushing and flushing requirements
- automated cleaning programmes
- rinsing
- drying
- inspection
- reassembly
- subsequent disinfection or sterilisation
- limitations on reuse where applicable
Manufacturers should avoid validating one process while providing users with materially different cleaning instructions.
How Does Usability Engineering Apply to Reprocessing Instructions?
Cleaning and reprocessing instructions should enable intended users to perform safety-critical steps correctly, including preparation, disassembly, cleaning and reassembly where applicable. Learn how use-related risks, user interfaces and usability validation are addressed within the medical device lifecycle in our Complete Guide to IEC 62366-1 Usability Engineering .
Documenting Cleaning Validation Results
Once testing has been completed, the results should be documented in a controlled cleaning validation report.
The report should provide sufficient information to demonstrate what was tested, how the study was conducted, what results were obtained and whether the predefined acceptance criteria were met.
What Should a Cleaning Validation Report Include?
A cleaning validation report should typically include:
- reference to the approved protocol
- device identification
- samples and configurations tested
- validation dates and locations
- test soils or contaminants used
- sample preparation and conditioning
- cleaning process performed
- actual process parameters
- analytical methods
- extraction and recovery information
- individual test results
- statistical analysis where applicable
- visual inspection results
- deviations from the protocol
- unexpected or failed results
- assessment against acceptance criteria
- conclusions
- required corrective actions or further testing
- review and approval
The report should not simply state that the cleaning process “passed”. The underlying results and the rationale supporting the conclusion should be clear and traceable.
Handling Deviations and Failed Results
Deviations, unexpected findings and failed results should be documented and appropriately investigated.
The manufacturer should determine:
- what occurred
- why it occurred
- whether the validity of the study was affected
- whether the cleaning process contributed to the result
- whether the acceptance criteria remain appropriate
- whether corrective action is required
- whether additional testing or revalidation is necessary
Failed samples should not simply be excluded from the validation dataset without a scientifically justified and documented reason.
When Is Cleaning Revalidation Required?
Cleaning validation should be maintained throughout the medical device lifecycle.
Changes that could affect cleaning effectiveness should be assessed through the manufacturer’s change-control and risk-management processes.
Potential triggers for cleaning revalidation include:
- changes to device design or geometry
- changes to materials or coatings
- new device sizes or configurations
- changes to manufacturing processes
- changes to expected contaminants
- changes to cleaning agents
- changes to cleaning-agent concentration
- changes to cleaning equipment
- changes to critical process parameters
- changes to water quality requirements
- changes to automated cleaning programmes
- changes to the reprocessing instructions
- changes to the claimed number of reuse cycles
- new information from complaints or post-market surveillance
- cleaning-related nonconformities or CAPA
- changes to applicable regulatory requirements or standards
Does Every Change Require Full Revalidation?
No. A change does not automatically mean that the entire cleaning validation must be repeated.
The manufacturer should perform a documented impact assessment considering whether the change affects:
- the nature or quantity of contamination
- device cleanability
- previously established worst-case conditions
- critical cleaning parameters
- analytical methods
- acceptance criteria
- cleaning-related risks
- the applicability of existing validation evidence
The outcome might justify continued reliance on the existing validation, limited additional testing, partial revalidation or full revalidation.
The important point is that the decision — including a decision not to revalidate — should be scientifically justified and documented.
Common Medical Device Cleaning Validation Mistakes
Cleaning validation deficiencies often arise not because no testing has been performed, but because the validation does not adequately demonstrate that the defined cleaning process is effective and reproducible.
Some of the most common problems include the following.
1. Relying on Visual Inspection Alone
A device can appear visually clean while still containing residual proteins, chemicals, detergents or other contamination.
Visual inspection can be a useful component of cleaning validation, but it should not replace appropriate analytical testing where residues below the level of visual detection could present a risk.
2. Using Acceptance Criteria Without Adequate Justification
Acceptance limits should not be selected simply because they have been used for another device or appear in a laboratory’s standard testing package.
The manufacturer should be able to explain why the selected limits are appropriate for the:
- device
- contaminant
- intended purpose
- patient contact
- associated risks
- analytical method
The rationale should be documented before validation testing begins.
3. Failing to Validate the Worst-Case Device
Testing the easiest device or configuration to clean provides limited evidence for more challenging products within the same family.
Worst-case selection should consider factors such as geometry, lumens, joints, surface area, materials, contamination and accessibility.
The rationale for the selected representative device should be documented.
4. Using Unrealistic Test Contamination
The contaminant or test soil used during validation should appropriately represent the contamination the cleaning process is expected to remove.
For reusable devices, the challenge should reflect reasonably foreseeable clinical contamination. For manufacturing cleaning, it should reflect relevant manufacturing residues.
An artificial challenge that bears little relationship to the actual contamination may provide weak evidence of cleaning effectiveness.
5. Ignoring the Delay Between Use and Cleaning
For reusable devices, contamination may become more difficult to remove if it is allowed to dry before cleaning.
Where a delay between use and reprocessing is reasonably foreseeable, the validation strategy should consider whether an appropriate worst-case delay needs to be challenged.
The manufacturer’s validated conditions should also be consistent with any time limitations stated in the Instructions for Use.
6. Failing to Demonstrate Extraction and Recovery
An analytical method may report very low levels of contamination simply because the extraction procedure cannot effectively recover residues from the device.
Where extraction is required, the manufacturer should have appropriate evidence that the method can recover the relevant contaminant from the surfaces being assessed.
This is particularly important for complex devices with lumens, joints, recesses or internal surfaces.
7. Validating a Process That Does Not Match the IFU
For reusable devices, the validated cleaning procedure should support the instructions supplied to the user.
Differences in detergent concentration, cleaning time, temperature, brushing, flushing, equipment or other critical parameters can undermine the relevance of the validation.
The validation evidence and Instructions for Use should therefore be reviewed together.
8. Assuming Washer-Disinfector Validation Is Sufficient
Qualification or validation of an automated washer-disinfector does not by itself demonstrate that every medical device placed within it will be adequately cleaned.
The manufacturer still needs evidence that the specified process is suitable for the particular device or device family.
9. Ignoring Repeated Reprocessing
A reusable device may become more difficult to clean as its surfaces, joints, coatings or other features change over repeated processing cycles.
Where relevant to the claimed device lifetime, validation should consider whether cleaning remains effective under appropriately aged or end-of-life conditions.
10. Failing to Assess Changes for Revalidation
Changes to device design, materials, cleaning agents, equipment, process parameters or reprocessing instructions can affect existing validation evidence.
Cleaning validation should therefore be incorporated into change control so that the need for additional testing or revalidation is formally assessed.
What Does Good Cleaning Validation Evidence Look Like?
A strong cleaning validation package should allow a reviewer to understand the complete rationale from the identified contamination risk through to the final validation conclusion.
There should be clear traceability between:
Device and Intended Use
↓
Contamination Risks
↓
Cleaning Requirements
↓
Cleaning Process
↓
Worst-Case Conditions
↓
Acceptance Criteria
↓
Test and Analytical Methods
↓
Validation Results
↓
Conclusion
↓
Instructions for Use / Technical Documentation
Good validation evidence should therefore demonstrate:
- what the cleaning process is intended to remove
- why cleaning is necessary
- which device or configuration represents the worst case
- why the test soil or contaminant is appropriate
- which process parameters are critical
- how acceptance criteria were established
- why the analytical methods are suitable
- how extraction and recovery were addressed
- why the sample size is appropriate
- what results were obtained
- how deviations or failures were handled
- whether the predetermined acceptance criteria were achieved
- how the validation supports the manufacturer’s claims and instructions
- when review or revalidation may be required
The objective is not simply to produce a cleaning validation report. It is to establish objective, traceable and scientifically justified evidence that the defined cleaning process can consistently achieve its intended result.
How Patient Guard Can Help with Medical Device Cleaning Validation
Patient Guard can support medical device manufacturers in developing, reviewing and documenting cleaning validation strategies for both manufacturing cleaning processes and reusable medical device reprocessing.
Our support can be tailored to the device, cleaning process, regulatory market and existing validation evidence.
Cleaning Validation Strategy and Gap Assessment
We can review existing cleaning processes and validation evidence to identify whether the documentation adequately supports the manufacturer’s regulatory requirements and claims.
This can include review of:
- existing cleaning validation protocols and reports
- cleaning procedures
- reusable-device processing instructions
- contamination and residue assessments
- acceptance criteria
- worst-case selection
- test methods
- extraction and recovery evidence
- applicable standards
- risk management documentation
- Technical Documentation
Where suitable evidence already exists, the aim should be to use and justify that evidence rather than automatically repeating testing.
Cleaning Validation Protocol Development
Patient Guard can support the preparation or review of cleaning validation protocols, including:
- validation scope
- device-family and worst-case selection
- test contaminants or soils
- cleaning parameters
- sample-size rationale
- acceptance criteria
- test methods
- extraction and recovery considerations
- protocol deviations
- documentation requirements
Where specialist laboratory testing is required, the protocol can also help define the testing that needs to be performed before samples are submitted.
Review of Cleaning Validation Results
Once testing has been completed, we can review the resulting evidence to assess whether it adequately supports the cleaning process and applicable regulatory requirements.
This can include review of laboratory reports, raw results, deviations, acceptance criteria and the manufacturer’s final validation conclusions.
Integration with Risk Management and Technical Documentation
Cleaning validation should not sit separately from the rest of the medical device Technical Documentation.
Patient Guard can help establish traceability between:
Cleaning-related hazards → Risk controls → Cleaning requirements → Validation evidence → Regulatory conformity
This may include integration with:
- ISO 14971 risk management
- ISO 13485 Quality Management Systems
- biological evaluation
- sterilisation validation
- packaging validation
- Instructions for Use
- design verification and validation
- EU MDR Technical Documentation
- UK MDR compliance documentation
Need Help with Medical Device Cleaning Validation?
Whether you are developing a cleaning validation strategy for a new medical device, validating the reprocessing instructions for a reusable device or responding to gaps identified during a regulatory review, Patient Guard can help determine what evidence is required and how it should be documented.
Frequently Asked Questions About Medical Device Cleaning Validation
Medical device cleaning validation is the documented process of demonstrating that a defined cleaning procedure can consistently reduce relevant contaminants and residues to predetermined acceptable levels.
The validation should consider the device, expected contamination, cleaning method, worst-case conditions, acceptance criteria and appropriate test methods.
Cleaning validation may be required where cleanliness is necessary for the safety, performance or subsequent processing of a medical device.
This can include manufacturing cleaning processes and the cleaning of reusable medical devices between uses. The need for validation should be determined based on the device, intended purpose, applicable regulatory requirements and risk assessment.
The ISO 17664 series addresses processing information that medical device manufacturers provide for devices requiring processing or reprocessing.
ISO 17664-1:2021 covers critical and semi-critical medical devices and devices intended to be sterilised, while ISO 17664-2:2021 addresses non-critical medical devices. The series includes requirements relating to cleaning and other applicable processing activities.
Cleaning verification provides evidence that specified cleaning requirements have been met in a particular assessment or instance.
Cleaning validation provides documented evidence that a defined cleaning process is capable of consistently achieving its predetermined requirements when operated under specified conditions.
Verification and validation therefore have related but different purposes, and verification should not simply be described as a one-time version of validation.
There is no universal sample number that applies to every cleaning validation.
Sample size should be scientifically justified based on factors such as device risk, process variability, device complexity, analytical methods, expected contamination, previous evidence and any applicable standards or guidance. Statistical justification should be used where appropriate.
Acceptance criteria should be established before validation testing and should be scientifically justified.
The manufacturer should consider the contaminant being assessed, intended purpose, patient contact, biological or toxicological risk, device design, subsequent processing, analytical method and relevant standards or scientific evidence.
There is no single cleanliness limit that is appropriate for every medical device.
Not necessarily.
Visual inspection can identify visible contamination, staining or residues, but contamination may remain at levels that cannot be seen, particularly within lumens, joints or other difficult-to-access areas.
Where residual contamination could present a risk below the level of visual detection, suitable quantitative or analytical testing should be considered.
A worst-case device is a device or configuration selected because it provides an appropriately challenging test of the cleaning process.
Factors may include narrow or long lumens, complex geometry, joints, surface area, textured materials, inaccessible surfaces, contamination levels or other characteristics that make the device more difficult to clean.
The manufacturer should document the rationale for the selected worst case, particularly where the validation is intended to represent a wider product family.
Where a reusable medical device requires cleaning between uses, the manufacturer should have appropriate evidence supporting the cleaning and reprocessing instructions supplied with the device.
Validation should consider realistic contamination, device design, cleaning parameters, worst-case conditions and, where applicable, the effect of repeated reprocessing over the claimed device lifetime.
Cleaning validation demonstrates that a defined cleaning process can adequately remove relevant contamination and residues.
Sterilisation validation demonstrates that a defined sterilisation process can consistently achieve the required sterility assurance while maintaining device suitability.
For reusable or terminally sterilised devices, effective cleaning may be an essential prerequisite to subsequent disinfection or sterilisation. Sterilisation should not be used to compensate for inadequate cleaning.
Potential triggers include changes to device design, materials, cleaning agents, equipment, process parameters, manufacturing processes, reprocessing instructions or the claimed number of reuse cycles.
Complaints, nonconformities, CAPA, post-market information and changes to applicable regulatory requirements or standards may also trigger review.
Not every change requires full revalidation. The manufacturer should perform and document an impact assessment to determine whether existing evidence remains valid or whether additional testing or revalidation is required.
References
This guide is based on current medical device legislation, international standards and official regulatory guidance relevant to medical device cleaning validation, reusable device processing, risk management and Quality Management Systems.
| Organisation | Reference | Why it's relevant |
|---|---|---|
| European Union | Regulation (EU) 2017/745 on Medical Devices (EU MDR) | Establishes EU medical device safety and performance requirements, including requirements relevant to contamination, infection, reusable devices, processing instructions and product verification and validation. |
| UK Government / MHRA | Medical Devices: Conformity Assessment and the UKCA Mark | Provides official guidance on conformity assessment for medical devices placed on the Great Britain market under the UK medical device regulatory framework. |
| UK Government | Designated Standards: Medical Devices | Provides the current UK notices and consolidated list of designated standards that can support conformity with applicable requirements of the UK Medical Devices Regulations 2002. |
| ISO | ISO 13485:2016 – Medical devices – Quality management systems – Requirements for regulatory purposes | Establishes medical device QMS requirements, including control and validation of production and service processes where applicable, documentation, change control and validation records. |
| ISO | ISO 14971:2019 – Medical devices – Application of risk management to medical devices | Provides the lifecycle risk management framework used to identify cleaning-related hazards, establish risk controls and evaluate whether those controls are effective. |
| ISO | ISO 17664-1:2021 – Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 1 | Specifies processing information manufacturers must provide for critical and semi-critical medical devices and devices intended to be sterilised, including applicable cleaning, disinfection, drying, inspection, packaging and sterilisation activities. |
| ISO | ISO 17664-2:2021 – Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 2 | Addresses processing information for non-critical medical devices and supports the development of appropriate cleaning and disinfection instructions. |
| ISO | ISO/TS 17664-3:2026 – Processing of health care products – Information to be provided by the medical device manufacturer for the processing of medical devices – Part 3 | Provides guidance on assigning reusable medical devices to cleaning classification categories, including consideration of device design, materials, intended use, product families and representative devices. |
| ISO | ISO 15883-1:2024 – Washer-disinfectors – Part 1: General requirements, terms and definitions and tests | Establishes general requirements for washer-disinfectors, including requirements relating to performance, validation, routine control, monitoring and requalification. |
| ISO | ISO 15883-2:2024 – Washer-disinfectors – Part 2 | Specifies requirements and tests for washer-disinfectors using thermal disinfection for reusable critical and semi-critical medical devices. |
| ISO | ISO 15883-5:2021 – Washer-disinfectors – Part 5: Performance requirements and test method criteria for demonstrating cleaning efficacy | Provides performance requirements and test-method criteria for demonstrating washer-disinfector cleaning efficacy, including approaches relating to test soils and assessment of cleaning performance. |
Note: The standards applicable to a medical device cleaning validation programme depend on the device, intended purpose, contamination risks, cleaning method and regulatory market. Manufacturers should assess applicability and confirm the current edition and regulatory status of each standard before use.
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