EUROLAB laboratory provides testing and compliance services within the scope of EN 13795-1 standard. This part of the EN 13795 standard describes the manufacturing and processing requirements of surgical gowns and drapes, and provides test methods to provide information to users and third-party verifiers in addition to the usual labeling of medical devices.
The EN 13795-1 standard is accepted as the European consensus standard for surgical gowns, surgical drapes and clean air suits. Major changes have been made in the last revision and the standard is divided into two parts. Part one describes the requirements and test methods for surgical drapes and gowns, while part two deals with fresh air suits.
The EN 13795-1 standard also refers to the following two standards in terms of application:
These standards define the requirements for the symbols used in labels containing information on the safe and effective use of medical devices.
The EN 13795-1 standard provides information on the characteristics of disposable and reusable surgical gowns and surgical drapes used as medical devices for employees, patients and equipment in order to prevent the transmission of infectious agents between clinicians and patients during surgical procedures. This standard provides test methods to evaluate the defined properties of surgical drapes and gowns and describes performance requirements for these products.
However, the EN 13795-1 standard does not cover the resistance requirements of products against penetration of laser radiation. Suitable test methods for resistance to penetration by laser radiation are included in the EN ISO 11810 standard.
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EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
