COVERALLS, GOWNS, SHOE COVERS
Disposable or reusable surgical garments and drapes are designed to prevent the transmission of infective agents between clinical staff and patients during surgical and other invasive procedures. The types defined by EN 13795-1 and EN 13795-2 standards include:
SURGICAL GOWN
Worn by a member of a surgical team to prevent the transfer of infective agents.
SURGICAL DRAPE
Covers the patient or equipment to prevent the transfer of infective agents.
CLEAN AIR SUIT
Consists of a shirt and trousers and optionally shoe covers, used as workwear to minimize airborne contamination in the operating room.
HOW TO PROCEED?
The product must comply with the provisions of Regulation (EU) 2017/745. Our laboratories conduct tests in accordance with the following standards:
EN 13795-1
Surgical clothing and drapes used as medical devices in health care facilities – Part 1 – Performance requirements and test methods – Surgical drapes and gowns.
EN 13795-2
Surgical clothing and drapes used as medical devices in health care facilities – Part 2 – Requirements and test methods – Clean air suits.
ISO 811
Textiles – Determination of resistance to water penetration.
EN 29073-3
Textiles – Test methods for nonwovens – Part 3: Determination of tensile strength and elongation.
ISO 9073-10
Textiles – Test methods for nonwovens – Part 10: Lint an dother particles generation in the dry state.