BS EN ISO 21171:2006

Overview

BS EN ISO 21171:2006 is a critical standard in the field of health care technology, specifically addressing the determination of removable surface powder on medical gloves. This standard is essential for ensuring that medical gloves meet safety and performance requirements, thereby protecting both healthcare professionals and patients from potential contamination.

Key Requirements

The standard outlines specific procedures and methodologies for assessing the amount of powder that can be removed from the surface of medical gloves. Key requirements include:

• Testing Methodology: The standard specifies a defined testing process to accurately measure the removable powder.
• Sample Preparation: Guidelines for preparing glove samples to ensure consistent and reliable results.
• Reporting Results: Clear instructions on how to document and report the findings from the tests conducted.
• Compliance Criteria: Establishes acceptable limits for removable powder, ensuring gloves are safe for use.

Implementation Benefits

Adhering to BS EN ISO 21171:2006 provides numerous benefits for manufacturers and healthcare providers:

• Enhanced Safety: By ensuring that gloves have minimal removable powder, the risk of allergic reactions and contamination is significantly reduced.
• Quality Assurance: Compliance with this standard enhances product quality, leading to greater trust from healthcare professionals.
• Market Access: Meeting the requirements of this standard can facilitate entry into various markets that mandate compliance with international standards.
• Regulatory Compliance: Aligning with this standard helps manufacturers meet regulatory requirements, reducing the risk of legal issues.

Compliance Value

Compliance with BS EN ISO 21171:2006 is not merely a regulatory obligation; it is a strategic advantage. The standard provides a framework for manufacturers to demonstrate their commitment to quality and safety. In an industry where trust is paramount, adherence to recognised standards can differentiate a brand and enhance its reputation.

Furthermore, compliance can lead to reduced liability risks and improved customer satisfaction. Healthcare providers can be assured that the gloves they use are safe and effective, which is crucial in maintaining high standards of patient care.

In conclusion, BS EN ISO 21171:2006 plays a vital role in the health care technology sector. By focusing on the determination of removable surface powder on medical gloves, this standard ensures that products are safe for use, thereby protecting both healthcare professionals and patients alike.