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Views: 19 Author: Site Editor Publish Time: 2021-04-23 Origin: Site
EN 13485 is a European standard that specifies the requirements for a quality management system (QMS) for medical device manufacturers. The standard is based on ISO 9001 and includes additional requirements specific to the medical device industry.
EN 13485 sets out the requirements for the entire life cycle of a medical device, from design and development, through manufacturing, installation, and servicing. The standard also covers the requirements for the QMS itself, including management responsibility, resource management, product realization, measurement, analysis and improvement, and the monitoring and control of external suppliers.
Compliance with EN 13485 is a legal requirement for medical device manufacturers selling their products in the European Union, and it is also recognized by regulatory bodies in other regions around the world. Certification to the standard demonstrates that a manufacturer has implemented a robust QMS and is committed to ensuring the safety and effectiveness of their medical devices.
One Top Protective Products Co.,Ltd has the EN13683 Type IIR certificate, you are rest assured our face masks are tested and approved both as medical equipment and for private use.
| Test | Type I | Type II | Type IIR |
| Bacterial filtration efficiency (BFE): The ability of the face mask to filter our bacteria so that they are not released into the user's surroundings (BFE), (%). | ≥ 95 | ≥ 98 | ≥ 98 |
| Differential pressure: The lower this value, the easier it is for the user to breath normally (Pa/cm2). | < 40 | < 40 | < 60 |
| Splash resistance pressure: The ability of the face mask to withstand the penetration of liquid splashes (kPa). | Not required | Not required | ≥ 16,0 |
| Microbial cleanliness: Microbial cleanliness documents cleanliness in the manufacturing process (cfu/g). | ≤ 30 | ≤ 30 | ≤ 30 |
