What is BS EN 136610:2011?

BS EN 136610:2011 is a technical standard that sets out requirements for the design, construction and performance of medical devices. It focuses specifically on medical devices used to prevent or treat infection in healthcare settings. This standard provides guidelines for manufacturers, regulators and users to ensure the safety and effectiveness of these devices.

Design and Construction Requirements

The BS EN 136610:2011 standard lays down specific design and construction requirements for medical devices. These include material selection, device dimensions, surface finish, and ergonomic features. The aim is to ensure that the device can be easily used, cleaned and sterilized without posing any risk to patients or healthcare personnel. Manufacturers must also consider factors such as durability and compatibility with other medical products in order to meet the requirements of the standard.

Performance Testing and Validation

In addition to design and construction requirements, BS EN 136610:2011 mandates stringent performance testing and validation procedures. These tests evaluate the device's ability to prevent or control infections and its overall performance under different conditions. Performance criteria such as bacterial filtration efficiency, fluid resistance, biocompatibility, and microbial cleanliness are assessed to determine compliance with the standard. Only devices that meet these performance requirements can be authorized for use in healthcare facilities.

Conformity Assessment and Certification

To ensure compliance with BS EN 136610:2011, manufacturers must undergo a conformity assessment process. This involves conducting internal audits and regular inspections by authorized notified bodies. These bodies assess the manufacturer's quality management system, design documentation, and test reports to verify compliance with the standard. Once the assessment is successfully completed, the manufacturer can obtain a certificate of conformity, demonstrating that their medical devices meet the requirements of BS EN 136610:2011.