BS EN ISO 4074:2015

Overview

BS EN ISO 4074:2015 specifies the requirements and test methods for natural rubber latex male condoms. This standard is crucial for ensuring the safety, effectiveness, and reliability of condoms used for contraception and the prevention of sexually transmitted infections (STIs). The standard outlines the necessary specifications that manufacturers must adhere to, ensuring that products meet the highest quality and safety standards.

Key Requirements

The standard encompasses a range of requirements that cover various aspects of condom manufacturing and testing. Key requirements include:

• Material Specifications: Condoms must be made from natural rubber latex, which should be free from harmful substances that could compromise safety.
• Physical Properties: The standard outlines specific physical properties, such as tensile strength, elongation, and thickness, which are critical for ensuring durability and reliability.
• Microbiological Safety: Condoms must undergo testing to ensure they do not support the growth of harmful microorganisms.
• Packaging and Labelling: Proper packaging and labelling are essential to ensure that the product remains uncontaminated and that users are informed about the correct usage and expiration dates.

Implementation Benefits

Adopting BS EN ISO 4074:2015 offers numerous benefits for manufacturers and healthcare providers:

• Enhanced Product Safety: Compliance with this standard ensures that condoms are safe for use, reducing the risk of failure during use.
• Market Confidence: Meeting the requirements of this standard can enhance consumer trust and confidence in the product, leading to increased market acceptance.
• Quality Assurance: The rigorous testing methods outlined in the standard help manufacturers maintain high-quality production processes, leading to consistent product performance.
• Regulatory Compliance: Adhering to this standard can facilitate compliance with national and international regulations, simplifying the approval process for market entry.

Compliance Value

Compliance with BS EN ISO 4074:2015 is not only a legal obligation but also a strategic advantage. By aligning manufacturing processes with this standard, companies can:

• Reduce Liability: Ensuring that products meet established safety standards can mitigate the risk of legal claims related to product failure.
• Access Global Markets: Many countries require compliance with international standards for medical devices, including condoms. Adhering to BS EN ISO 4074:2015 can facilitate entry into these markets.
• Improve Customer Satisfaction: High-quality products that meet safety standards contribute to user satisfaction, which is essential for brand loyalty and repeat purchases.

In conclusion, BS EN ISO 4074:2015 is a vital standard for the production of natural rubber latex male condoms. It provides a framework for ensuring product safety, quality, and compliance, ultimately benefiting manufacturers, healthcare providers, and consumers alike.