Overview of HTM 01-06 Endoscopy Validation
HTM 01-06 endoscopy validation ensures that washer disinfectors used in endosope reprocessing are performing in accordance with current guidance and manufacturer requirements. Regular validation provides assurance that cleaning and disinfection processes are effective, supporting both patient safety and regulatory compliance.
We support healthcare providers across the UK and Republic of Ireland, delivering weekly, quarterly and annual validation services in line with HTM 01-06 and ISO 15883 standards.
HTM 01-06 & ISO 15883 Compliant
Complete Validation Testing
Flexible Validation Schedules
Trusted by Healthcare Providers
What is included in endoscopy validation?
Endoscopy validation involves a series of tests designed to confirm that washer disinfectors are functioning correctly and consistently meeting required standards.
Validation typically includes:
- Safety and operational checks
- Automatic Control Tests (ACT)
- Calibration verification
- Leak and patency testing
- Cleaning efficacy testing
- Thermometric testing
Together, these tests provide a complete assessment of equipment performance and compliance.
Weekly testing and routine monitoring
Under HTM 01-06 guidance, validation should be supported by routine daily and weekly testing carried out by the user or CP(D). These regular checks help ensure washer disinfectors continue to operate effectively between validation periods and allow potential issues to be identified early.
Weekly testing may include:
- Automatic Control Tests (ACT)
- Cleaning efficacy tesing using process challenge devices (PCDs), including TVC testing
- Protein residue testing
- Leak and patency checks
- Water quality monitoring
Routine testing plays an important role in maintaining compliance, supporting patient safety, and ensuring consistent decontamination performance.
For facilities requiring support with routine testing, our team can provide guidance, testing products, and laboratory services.
Our validation process
Validation is carried out using a structured and planned approach to ensure efficiency and minimal disruption.
This process includes:
- Agreeing a schedule with your department
- Booking and confirming visit dates in advance
- Carrying out on-site validation testing
- Completing all testing in accordance with HTM 01-06 and ISO 15883
- Generating and issuing electronic validation reports
All work is carried out by qualified engineers to recognised standards.
Trusted across healthcare providers
We currently support multiple NHS hospitals and private healthcare groups, delivering validation services across a wide range of equipment.
Validation can be carried out on washer disinfectors including:
- Getinge/Lancer – ED Flow, FC2, FC4
- Cantel – RapidAER
- Medivator – MDS, DSD
- Wassenburg – WD440
- Steelco & many more
We also provide validation services for:
- Endoscope Washer Disinfectors (EWDs)
- Ultrasonic cleaning equipment
- Autoclaves
- Instrument washers
- Water systems
Why validation is important
Washer disinfectors play a critical role in endoscope reprocessing and their reprocessing, and their performance must be consistently maintained to ensure effective cleaning and disinfection.
Under HTM 01-06 guidance, equipment is required to follow a planned programme of testing and maintenance. This ensures that washer disinfectors continue to operate within the required parameters and meet the necessary standards.
Validation helps to:
- Confirm equipment is operating within required parameters
- Identify potential issues before they impact performance
- Maintain consistent cleaning and disinfection standards
- Support infection prevention and control
- Ensure ongoing compliance with current guidance
Without regular validation, equipment may decline over time, increasing risk of ineffective decontamination and potential impact on patient safety.
Key benefits
- Supports compliance with HTM 01-06 and ISO 15883
- Provides clear documentation for audits and inspections
- Identifies issues before they impact performance
- Helps maintain safe and effective decontamination processes
- Builds confidence in equipment performance
Frequently Asked Questions
We are flexible and can provide both one-off validations and annual contracts depending on you requirements. While annual contracts typically offer the best value, we are happy to work around what suits your facility best.
If a failure is identified, a non-conformance report is raised outlining the issue and recommended actions, and advice on possible next steps. This helps you address the problem quickly, maintain compliance, and ensure equipment continues to perform effectively.
You will receive a detailed electronic validation report outlining results, compliance status and any actions required, providing clear evidence for audits and inspections.
Validation is part of a structured testing programme which should also include daily and weekly testing carried out by the user or CP(D). If you are not currently carrying out weekly testing, our team can provide guidance and support to help you implement an effective routine testing programme.
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