ISO 16603:2004 outlines a standardized method for determining the resistance of protective clothing materials to penetration by blood and body fluids using synthetic blood under conditions of continuous liquid contact. This certification is especially relevant in industries where workers are exposed to biological hazards, such as healthcare, laboratories, emergency response, and industrial environments where contamination risks are high. The standard serves as an important measure of the initial barrier effectiveness of protective garments in safeguarding against infectious materials.

The test method used in ISO 16603:2004 evaluates the performance of fabric or clothing material by exposing it to synthetic blood at various pressure levels to determine its resistance to liquid penetration. This helps in identifying which materials can offer a reliable barrier against potential bloodborne pathogens. It acts as a preliminary screening before conducting more advanced testing like ISO 16604, which checks for viral penetration. Compliance with this standard is often a prerequisite for certifying the biological protection level of garments such as surgical gowns, coveralls, and other protective equipment.

Obtaining ISO 16603:2004 certification signifies that an organization’s protective clothing products meet internationally recognized safety benchmarks. It assures end users—particularly medical and emergency personnel—that the materials used in their gear have undergone rigorous testing and are capable of offering essential protection in high-risk environments. At ExpertISO, we provide thorough support in achieving ISO 16603 certification, from understanding test requirements to preparing technical documentation and coordinating with accredited testing bodies—ensuring that your protective solutions meet global standards for safety and reliability.