surgical gowns

• How to meet EN13795 standards for surgical drapes and gowns?

  Mar 26, 2026

  For surgical drapes and surgical gowns that aim to enter the European market, meeting the EN 13795 standard is no longer an optional requirement; it has become the cornerstone for market entry. The core objective of this standard is very clear: to prevent the spread of infectious agents between healthcare workers and patients, and to ensure that the microbial and viral barrier effect during the surgical procedure reaches a reliable level. The new version of standard EN 13795-1:2025 was adopted by the European Commission as a harmonized standard under the Medical Device Regulation (MDR) in October 2025. This means that products that comply with this standard can be presumed to meet the compliance requirements of the MDR.   The key to meeting this standard lies in whether the produ...

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