BS EN 455-4:2009

Overview

BS EN 455-4:2009 outlines the requirements and testing methods for determining the shelf life of single-use medical gloves. This standard is crucial for ensuring that medical gloves maintain their integrity and performance throughout their intended shelf life, thereby safeguarding patient safety and compliance with regulatory requirements.

Key Requirements

The standard specifies a series of tests and criteria that manufacturers must adhere to when assessing the shelf life of medical gloves. Key requirements include:

• Stability Testing: Gloves must undergo stability testing under specified conditions to evaluate their physical and chemical properties over time.
• Packaging Integrity: The packaging must protect the gloves from environmental factors that could compromise their quality.
• Labeling Requirements: Clear labeling of the shelf life on the packaging is mandatory, ensuring users are informed of the product's usability period.
• Storage Conditions: Guidelines for optimal storage conditions must be established to maintain glove performance.

Implementation Benefits

Adhering to BS EN 455-4:2009 provides several practical benefits for manufacturers and healthcare providers:

• Enhanced Safety: By ensuring gloves are effective throughout their shelf life, patient safety is significantly improved.
• Regulatory Compliance: Compliance with this standard helps manufacturers meet legal and regulatory obligations, reducing the risk of penalties.
• Market Confidence: Demonstrating adherence to recognised standards enhances trust among healthcare providers and patients.
• Quality Assurance: Implementing the requirements of this standard fosters a culture of quality within manufacturing processes.

Compliance Value

Compliance with BS EN 455-4:2009 not only ensures the safety and effectiveness of medical gloves but also aligns with broader regulatory frameworks governing medical devices. This standard is part of the European Union's Medical Device Directive, which mandates that all medical devices, including gloves, meet specific safety and performance criteria.

By following the guidelines set forth in this standard, manufacturers can effectively demonstrate that their products are safe for use, thereby facilitating smoother market access and reducing the likelihood of product recalls or legal challenges. Furthermore, adherence to BS EN 455-4:2009 can enhance a manufacturer's reputation and competitive edge in the healthcare market.

In conclusion, BS EN 455-4:2009 is an essential standard for the medical glove industry, providing clear guidelines for shelf life determination. Compliance with this standard not only protects patients but also supports manufacturers in achieving regulatory compliance and maintaining high-quality production practices.