1. Overview of Key Standards
ISO 11193-1
This international standard specifies the requirements for single-use medical examination gloves made of natural rubber latex or synthetic materials. It includes testing for tensile properties both before and after accelerated aging.
Key Focus:
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Tensile strength (minimum 14 MPa before aging; 14 MPa after aging)
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Elongation at break (min. 500% before aging; 400% after aging)
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Dimensional consistency (length, width)
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Sampling and conditioning protocols
EN 455-2
The European standard EN 455-2 sets physical property requirements for medical gloves, ensuring strength and integrity during use.
Test Criteria:
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Force at break: minimum 6.0 N for examination gloves
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Dimensional requirements
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Accelerated aging to simulate shelf-life effects
ASTM D6319
Primarily applicable to nitrile examination gloves, this ASTM standard includes similar physical property tests with a focus on quality assurance for the U.S. market.
Key Measures:
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Tensile strength and elongation (before and after aging)
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Glove thickness and dimensions
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Inspection levels and sampling plans
2. Common Test Types
Tensile Strength and Elongation
Performed using universal testing machines (UTMs), tensile tests determine the glove’s resistance to breaking under stress. A dumbbell-shaped specimen is stretched at a constant rate until rupture. Data such as maximum force and percentage elongation are recorded.
Dimensional Measurements
Gloves are measured for length and palm width using calibrated rulers or digital calipers. These measurements ensure the gloves conform to user fit expectations and regulatory norms.
Aging Simulation
Gloves are conditioned in controlled ovens (typically 70°C for 166 hours) to simulate the effects of time and environmental exposure. Post-aging performance is then evaluated using the same tensile tests.
3. Testing Equipment and Best Practices
A high-precision universal testing machine with suitable grips and software is essential for tensile and elongation measurements. To ensure repeatability and compliance:
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Maintain controlled ambient conditions (23°C ± 2°C, 50% ± 5% RH)
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Use pre-conditioned specimens (at least 24 hours)
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Calibrate machines regularly
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Follow specified test speeds (usually 500 mm/min or 750 mm/min)
4. Application in Quality Assurance
Physical properties testing is vital for both production quality control and regulatory compliance. Gloves that fail to meet tensile strength or force-at-break criteria can pose risks of tearing during use, compromising safety.
Routine testing according to these standards ensures that gloves remain effective barriers against contaminants and meet end-user expectations in clinical and laboratory settings.
5. Conclusion
Adherence to ISO 11193-1, EN 455-2, and ASTM D6319 provides a robust framework for validating the mechanical integrity of medical gloves. As global demand for high-quality protective equipment grows, consistent physical properties testing ensures trust and safety across healthcare environments.
