The EN 13795 standard, which describes the requirements and test methods for surgical gowns and drapes, is actually a European standard. In addition to the usual labeling of medical devices, this standard describes information to be given to users and third-party verifiers, as well as production and processing requirements.
The EN 13795 standard provides information on the characteristics of disposable and reusable surgical gowns and drapes used as medical devices to prevent contamination of infective agents between clinicians and patients during surgery and other medical procedures. It also provides test methods and performance requirements for these products to evaluate the determined properties of these surgical drapes and gowns.
However, this standard does not cover the requirements for resistance of these surgical products to laser radiation exposure. Test methods for resistance to laser radiation penetration with a suitable classification system are described in the EN ISO 11810 standard.
The EN 13795 standard does not include requirements for antimicrobial treatments for surgical gowns and drapes. Antimicrobial therapy can cause environmental pollution risks. However, surgical gowns and drapes used in antimicrobial therapy fall within the scope of this document for their use.
Briefly, surgical drapes are generally used in operating theaters to protect the patient, clinical staff and equipment. These covers can be made of fabric or paper and can be reused or disposable.
This series of standards, consisting of two parts, has been published in our country by the Turkish Standards Institute (TSE) with the following titles:
Within the scope of protective clothing tests, TS EN 13795-1 Surgical garments and drapes testing services are also provided by our organization.
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