ISO 16038:2017

Overview

ISO 16038:2017 - "Male condoms - Guidance on the use of ISO 4074 and ISO 23409 in the quality management of condoms" - is a guidance standard from ISO that explains how to apply the product standards ISO 4074 (natural rubber latex condoms) and ISO 23409 (synthetic-material condoms) within a quality management framework. It focuses on designing, manufacturing, verifying and procuring condoms with emphasis on performance, safety and reliability and clarifies points that apply to both latex and synthetic condoms.

Key topics

• Quality of design: design control, validation of new or significantly modified condom designs, clinical investigation where required, and documentation for regulatory submission.
• Risk management: risk analysis, latex allergy considerations, microbial contamination (bioburden) and nitrosamine control.
• Quality of manufacture: implementation of quality management systems, lot (finished product) testing and rounding-off rules for test values.
• Quality in procurement and testing: buyer verification, supplier communication and third‑party laboratory testing best practices.
• Important technical parameters: application of ISO 4074/23409, dimensions and tolerances (including thinner and non‑standard sizes), visibly open seals, freedom from holes testing, type testing, shelf life and resistance to degradation, compatibility of materials, lubricants, and packaging and labelling.
• Sampling and acceptance: guidance on sampling plans (including switching rules) and lot acceptance procedures consistent with standardized sampling methods.

Practical applications and who uses it

ISO 16038:2017 is intended for:

• Condom manufacturers - to integrate ISO 4074/23409 into product development, process validation, lot testing and quality systems.
• Procurement agencies and buyers - to define specifications, verify supplier conformity and reduce unnecessary testing through clear requirements.
• Regulatory authorities and notified bodies - to evaluate design validation, risk management and compliance evidence.
• Testing laboratories - to apply appropriate methods for freedom‑from‑holes, burst testing, dimensional checks and stability studies.
• Public health and procurement programs - to ensure condoms supplied for family planning or STI prevention meet reliable, standardized quality criteria.

Using ISO 16038 helps stakeholders reduce product risk, improve manufacturing consistency and demonstrate that condoms meet internationally recognized safety and performance practices.

Related standards

• ISO 4074:2015 - Natural rubber latex male condoms - requirements and test methods
• ISO 23409:2011 - Male condoms made from synthetic materials - requirements and test methods
• ISO 13485 and ISO 9001 - quality management system requirements
• ISO 14971 - risk management for medical devices

Keywords: ISO 16038:2017, male condoms, ISO 4074, ISO 23409, quality management, condom manufacturing, condom testing, shelf life, freedom from holes, risk management.