ISO 11193-2:2006

Overview

ISO 11193-2:2006 specifies the requirements for single-use medical examination gloves made from poly(vinyl chloride) (PVC). These gloves are essential in healthcare settings, providing a barrier between healthcare professionals and patients to prevent the transmission of infections. The standard outlines the necessary performance characteristics, testing methods, and quality assurance measures to ensure that gloves meet safety and efficacy standards.

Key Requirements

• Material Composition: Gloves must be made from poly(vinyl chloride), ensuring they are suitable for medical use.
• Physical Properties: The standard defines specific requirements for tensile strength, elongation, and puncture resistance to ensure durability during use.
• Biocompatibility: Gloves must be tested for biocompatibility to ensure they do not cause adverse reactions when in contact with skin.
• Microbial Barrier: Gloves must provide an effective barrier against microorganisms, reducing the risk of cross-contamination.
• Packaging and Shelf Life: The standard specifies requirements for packaging to maintain glove integrity and defines shelf life to ensure usability.

Implementation Benefits

Adopting ISO 11193-2:2006 in healthcare settings offers numerous benefits:

• Enhanced Safety: Compliance with this standard ensures that gloves provide adequate protection against pathogens, safeguarding both healthcare workers and patients.
• Quality Assurance: The standard's rigorous testing and quality assurance protocols help healthcare facilities maintain high standards of care.
• Regulatory Compliance: Adhering to ISO 11193-2:2006 supports compliance with national and international regulations, facilitating smoother operations and reducing legal risks.
• Improved Patient Outcomes: By using compliant gloves, healthcare providers can reduce the incidence of healthcare-associated infections, leading to better patient outcomes.

Compliance Value

Compliance with ISO 11193-2:2006 is crucial for healthcare organisations aiming to uphold the highest standards of patient safety and care. The standard provides a framework for evaluating glove performance, ensuring that only high-quality products are used in medical examinations and procedures. By implementing this standard, organisations can demonstrate their commitment to safety and quality, which is increasingly important in today's healthcare environment.

Furthermore, compliance can enhance the reputation of healthcare providers, as patients and regulatory bodies increasingly scrutinise safety practices. By utilising gloves that meet ISO 11193-2:2006, healthcare facilities can mitigate risks associated with glove failure, thereby protecting their staff and patients alike.