EN ISO 4074:2026 PDF

Overview

EN ISO 4074:2026 - Natural Rubber Latex Male Condoms: Requirements and Test Methods specifies the quality, safety, and performance criteria for male condoms made from natural rubber latex. Published by the European Committee for Standardization (CEN) and based on ISO 4074:2026, this international standard details essential technical requirements and standardized test methods for manufacturers, regulators, and testing laboratories involved in the production and evaluation of male latex condoms.

The standard ensures condoms meet criteria for mechanical barrier effectiveness, protection against sexually transmitted infections (STIs), and contraceptive reliability. It does not cover requirements for medicinal substances applied to condoms, which are subject to separate national or regional regulations.

Key Topics

• Quality Management and Verification

  • Emphasizes the need for a Quality Management System (QMS) conforming to international medical device standards (ISO 13485).
  • Details sampling plans and acceptance criteria to verify lot conformity.

• Design and Dimensional Requirements

  • Specifies minimum and tolerances for condom length (typically not below 160 mm unless otherwise justified), width, and thickness.
  • Requires condoms to have an integral bead and sets guidelines for their shape and fit.

• Safety, Biocompatibility, and Microbial Testing

  • Mandates biocompatibility assessments in line with ISO 10993 series.
  • Recommends minimizing microbial contamination, with methods for microbial testing included.
  • Tests for absence of holes (using both water leak and electrical methods), bursting pressure, and volume are standardized.

• Stability, Packaging, and Labelling

  • Defines procedures for estimating and verifying shelf life, including real-time and accelerated stability testing.
  • Stipulates requirements for packaging integrity and informative, standardized labeling.

• Test Methods and Reporting

  • Contains detailed, internationally accepted methods for physical and microbiological evaluation.
  • Outlines procedures for reporting test results to ensure transparency and compliance.

Applications

EN ISO 4074:2026 is essential for multiple stakeholders:

• Manufacturers of Male Latex Condoms

  • Provides a globally recognized framework for product design, safety evaluation, and routine production testing.
  • Supports compliance with health regulations and enables market access across Europe and internationally.

• Testing Laboratories

  • Guides accredited labs (conforming to ISO/IEC 17025) in performing standardized safety and quality tests.
  • Ensures reliable, reproducible results for certification and regulatory submissions.

• Regulatory Authorities & Procurement Bodies

  • Facilitates uniform assessment of condom batches for public health programs and government tenders.
  • Enhances consumer trust by mandating rigorous quality control throughout the product’s lifecycle.

• Health and Family Planning Organizations

  • Underpins public health messaging by assuring users of the effectiveness of certified condoms in STI prevention and contraception.

Related Standards

Implementing EN ISO 4074:2026 may require reference to additional international standards, including:

• ISO 13485 – Medical devices: Quality management systems
• ISO 14971 – Application of risk management to medical devices
• ISO 10993 Series – Biological evaluation of medical devices (Parts 1, 5, 10, 23)
• ISO 2859-1 – Sampling procedures for inspection by attributes
• ISO/IEC 17025 – Requirements for testing and calibration laboratories
• ISO 16038 – Guidance for the application of ISO 4074
• ISO 15223 Series – Labelling and symbols for medical devices

Compliance with EN ISO 4074:2026 is central to guaranteeing that natural rubber latex condoms are safe, reliable, and meet the highest international standards for personal and public health protection.