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Surgical Gowns and Drapes – ISO 16603 and 16604

Nelson Labs offers a comprehensive set of tests for surgical gown and drape barrier performance and biocompatibility. These tests are essential to ensuring performance properties are validated to support marketing label claims and to classify surgical drapes and gowns. The number of test sites and product classification determine the type of test to be performed. The requirements for ISO 16603 (Synthetic Blood Penetration) and 16604 (Viral Penetration) are similar to the ASTM standards; however, there are specific requirements for time points and classification. Based on the guidance document, compatibility assessment should occur for each material and for each site, if different.

For CE marking submissions, additional tests may be required for surgical gowns and drapes following EN 13795. Manufacturers should also consider the microbial cleanliness of the gown following EN ISO 11737-1 using the bioburden test method.

Particle shedding properties and biocompatibility should also be assessed depending on the material type and intended use.

Summary of tests for ISO 16603 and 16604:

Summary of tests for EN 13795:

  • Resistance to liquid penetration, EN 20811
  • Resistance to wet bacterial penetration, ISO 22610
  • Resistance to dry microbial penetration, ISO 22612
  • Evaluation of bursting strength in dry state, ISO 13938-1
  • Evaluation of bursting strength in wet state, ISO 13938-1
  • Tensile test (Dry), EN 29073-3
  • Tensile test (Wet), EN 29073-3
  • Particle shed analysis or linting: Gelbo flex test, ISO 9073-10

Additional tests to consider for surgical gowns and drapes:

Applicable Standards

  • EN 13795
  • ISO 16603 and ISO 16604
  • AAMI PB70

Testing Locations

Study Outline

See individual test pages linked above for test specific study outlines.

If you have additional questions about Surgical Gowns and Drapes testing, or would like to consult with the experts at Nelson Labs, just send us a request or call us at (801) 290-7500.