Our many years of laboratory experience in textile materials and non-woven fabric has enabled us
to develop expertise in the field of surgical gowns and drapes.

Disposal or reusable surgical gowns and drapes are mainly used for patients, surgical staff and equipment. They are designed to prevent the transmission of infectious agents between surgical staff and patients during surgical procedures and other invasive procedures. The types defined by standard EN 13795-1 and EN 13795-2 are as follows:

  • surgical grown: worn by a member of a surgical team to prevent the spread of infectious agents
  • surgical drape: covers the patient or the equipment to prevent the spread of infectious agents
  • clear air suit: comprising a shirt and trousers and possibly shoe covers, used as occupational clothing, intended to minimise air contamination in the operating theatre by skin cells

How to proceed

For all three types (surgical gown, surgical drape, clean air suit), the product must comply with the provisions of Regulation (EU) 2017/745. Our laboratories verify conformity according to the following standards:

EN 13795-1

Surgical clothing and drapes – Requirements and test methods. Surgical drapes and gowns

EN 13795-2

Surgical clothing and drapes – Requirements and test methods. Clean air suits

ISO 811

Textiles — Determination of resistance to water penetration

EN 29073-3

Textiles – Methods of test for nonwovens. Determination of tensile strength and elongation

ISO 9073-10

Textiles — Test methods for nonwovens — Part 10: Lint and other particles generation in the dry state

ISO 22610

Test method to determine the resistance to wet bacterial penetration

ISO 22612

Test method for resistance to dry microbial penetration

EN ISO 10993-1

Biological evaluation of medical devices: Evaluation and testing

EN ISO 10993-5

Biological evaluation of medical devices: in vitro cytotoxicity testing

EN ISO 10993-10

Biological evaluation of medical devices: Tests for irritation and delayed-type hypersensitivity

EN ISO 10993-18
Biological evaluation of medical devices: Chemical characterization of medical device materials within a risk management process
EN 1041

Information supplied by the manufacturer of medical devices

EN ISO 15223-1

Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied

When testing is complete, you will have to:

  • prepare the technical file in compliance with Annex II to Regulation (EU) 2017/745
  • apply the CE marking on the Medical Device
  • prepare the EU declaration of conformity (conforming to Annex IV to Regulation (EU) 2017/745), complete with an indication of the SRN (supplier’s unique code) and UDI D (device’s unique code)
  • register with the Database of the Ministry of Health and the European EUDAMED

Intervention from a notified body is only required for gowns and drapes subjected to a sterilization process (Category Is) and/or intended for use in invasive surgery (Category IIa).

Keep the EU declaration of conformity and the technical file for 10 years from when the Medical Device is placed on the market.

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