SURGICAL DRAPES END GOWNS
EN 13795: 1-2019 Surgical clothing and drapes
EN 13795-1: 2019 Surgical clothing and clothing - Requirements and test methods Chapter 1: Surgical Drapes and Gowns
Title: Surgical drapes, gowns and clean air clothing used as medical devices for patients, clinical staff and equipment The EN 13795 standard, which describes the requirements and test methods for surgical garments and drapes, actually a European standard.
This standart,explains the information to be provided to users and third-party validators ,and their production and processing requirements in adiidtion to the usual labelling of medical devices
The EN 13795: 1-2019 standard provides information on the properties of disposable and reusable surgical gowns, wipes used as medical devices to prevent the transmission of infectious agents between doctors and patients during surgery and other medical procedures. It provides also test methods to evaluate the specified properties of these surgical drapes and gowns and the performance requirements for these products.
AAMI: Advanced Medical Devices Association. AAMI PB70 is the US reference standard that establishes a classification system based on the liquid barrier performance of protective clothing and fabrics and defines the relevant labeling requirements and standardized test methods.