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Surgical Textiles

Surgical textile such as drapes and gowns are an essential part of infection control in healthcare settings for protecting both patients and clinical staff. The products are intended to reduce the risk of post-operative infections by creating a sterile barrier to prevent microorganisms from the healthcare worker’s clothes and skin from contaminating the surgical field. In addition, the products shield healthcare personnel from exposure to bodily fluids and other potentially infectious materials during surgical procedures.

In Europe the standard EN 13795-1 is widely used by procurement organisations to characterise single-use and reusable products, as well as to assess performance requirements. The standard aims to ensure these products provide adequate protection against the transmission of infective agents during surgery and other invasive procedures. Key aspects of EN 13795 include:

  • Mechanical Resistance: This includes tests for burst resistance (EN ISO 13938-1) and tensile strength (EN 29073-3) to ensure the gown can withstand physical stress.
  • Liquid Penetration Resistance: Tests like EN ISO 811 measure the gown’s ability to resist liquid penetration, which is crucial for preventing bodily fluids from reaching the wearer.

textiles test

  • Microbial Penetration and Cleanliness: EN ISO 22610 and EN ISO 22612 assess the gown’s resistance to wet and dry bacterial penetration. EN ISO 11737-1 is usually only performed on non-sterile products as a bioburden estimate to determine the appropriate sterilisation criteria.
  • Linting Propensity: ISO 9073-10 tests for lint generation to ensure that the gown does not shed fibres that could contaminate the surgical field.

textiles test

  • Weak Areas: Testing is intended to be performed on finished (ready to use) product and testing areas shall include weak spots e.g. all types of joints in critical areas such as seams in gown sleeves and repaired areas of reusable textiles. Please see our paper on SMTL work with accredited colleagues to offer testing to all sections of EN 13795. 

 

If you wish to commission testing of your gowns and drapes to demonstrate compliance with the European Standards then contact the SMTL and we will be able to arrange a full or phased testing programme to suit your needs: smtl.info@wales.nhs.uk

 

Relavent Standards

  • EN 13795-1 Surgical clothing and drapes - Requirements for and test methods: Surgical drapes and gowns
  • BS EN 13795-2 Surgical clothing and drapes. Requirements and test methods - Clean air suits
  • EN ISO 13938-1 Textiles - Bursting properties of fabrics - Part 1: Hydraulic method for determination of bursting strength and bursting distension
  • EN 29073-3 Textiles - Test methods for nonwovens - Part 3: Determination of tensile strength and elongation
  • EN ISO 811 Textiles - Determination of resistance to water penetration - Hydrostatic pressure test
  • EN ISO 11737-1 Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
  • EN ISO 22610 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration
  • EN ISO 22612 Clothing for protection against infectious agents - Test method for resistance to dry microbial penetration
  • EN ISO 9073-10 Textiles - Test methods for nonwovens - Part 10: Lint and other particles generation in the dry state