SMTL have been testing urology products such as Urine Collection Bags and Urethral Catheters for the Welsh NHS for over 40 years. These products are used in huge quantities in the NHS for patient bladder management where bladder emptying, urinary retention and other urinary conditions exist. The prevalence of catheter use varies across different settings and patient groups; however, NHS studies have conservatively estimated that 12% of all hospitalised patients are catheterised.
SMTL are UKAS accredited for testing Urine Collection Bags (BS EN ISO 8669-2) and Urethral Catheters (BS EN ISO 20696).
Urine Collection Bags
ISO 8669-2 specifies the performance requirements and test methods for urine collection bags, both body-worn and non-body-worn. Some key aspects covered by this standard include:
- Performance Requirements:
- Leakage Resistance: Ensures bags do not leak under various conditions which is critical for patient safety and hygiene.
- Strength of Attachment: Tests the strength of the attachment system and inlet tubing to minimise separation during use and ensuring that bags can withstand expectant daily use without failure.
- Non-Return Valve: Ensures urine does not flow back into the catheter reducing the risk of infections.
- Volume Capacity and Flow Rate: Testing verifies that the bags can handle the expected urine volume without backflow or blockage.
- Impact Resistance: Tests the bag’s ability to withstand impacts.
- Test Methods:
- Rated volume
- Freedom from leakage without load
- Freedom from leakage under load
- Freedom from leakage under impact
- Non-return valve assessment
- Strength of cutouts
- Strength of button system
- Strength in integral systems
- Strength of attachment of inlet tubing
- Filling flow rate
- Dimensions
- Test volume determination
This standard ensures that urine collection bags are safe, reliable, and effective for medical use.
If you wish to commission testing of your urine collection bags so that you can demonstrate safe practise and compliance to ISO 8669-2, then contact the SMTL: smtl.info@wales.nhs.uk
Urethral Catheters
ISO 20696 specifies the requirements and test methods for sterile urethral catheters for single use, with or without a balloon. The key tests included in this standard:
- Strength and Security:
- Tensile Strength: Ensures the catheter can withstand pulling forces.
- Balloon Integrity: Tests the balloon’s ability to inflate and deflate without leaking.
- Connector Security: Assesses the tensile strength between catheter and urine collection bags.
- Flow and Functionality:
- Flow Rate: Measures the rate at which fluids can pass through the catheter.
- Kink Resistance: Ensures the catheter maintains its shape and functionality when bent.
- Material and Safety:
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- Corrosion Resistance: Ensures the catheter material does not degrade in the body.
- Surface Finish: Ensures the catheter is free from extraneous matter, process and surface defects that may present an unacceptable risk of patient harm.
- Dimensional Accuracy:
- Outer Diameter: Verifies the catheter’s external dimensions.
- Effective Length: Measures the length of the catheter that can be inserted into the body.
- Marking, Labelling and Packaging requirements:
These tests are designed to ensure that the catheters are safe, reliable, and effective for medical use.
If you wish to commission testing of your urethral catheters so that you can demonstrate compliance to ISO 20696 and safe practise, then contact the SMTL: smtl.info@wales.nhs.uk