What is EN ISO 27327:2011?

EN ISO 27327:2011 is a technical standard that specifies the requirements for surgical masks and surgical respirators. This standard was published by the European Committee for Standardization (CEN) and provides guidance on the performance, classification, and testing of these medical devices.

Importance of EN ISO 27327:2011

The EN ISO 27327:2011 standard plays a crucial role in ensuring the safety and effectiveness of surgical masks and surgical respirators used in healthcare settings. It sets benchmarks for product quality, filtration efficiency, breathability, and bacterial filtration efficiency (BFE). Compliance with this standard is essential to protect both healthcare professionals and patients.

Performance Requirements

EN ISO 27327:2011 clearly outlines the performance requirements for surgical masks and surgical respirators. It covers aspects such as pressure drop, particle filtration efficiency, breathing resistance, and biocompatibility. Compliant products must meet specific criteria to provide adequate protection against the transmission of airborne particles and biological hazards.

Testing and Classification

The standard defines test methods and procedures to evaluate the performance of surgical masks and surgical respirators. These tests are conducted to assess various parameters like filtration efficiency, bacterial filtration efficiency, splash resistance, and compatibility with skin. Based on their performance, these medical devices are classified into different types or classes.