NEN-EN 13795-1:2019 en

Current standard
33 Pages
Publication date 2019-04-01
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Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
NEN-EN 13795-2: specifies information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices (see EN 1041 and EN ISO 15223-1), concerning manufacturing and processing requirements. This document gives information on the characteristics of single-use and reusable surgical gowns and surgical drapes used as medical devices for patients, clinical staff and equipment, intended to prevent the transmission of infective agents between clinical staff and patients during surgical and other invasive procedures. This document specifies test methods for evaluating the identified characteristics of surgical drapes and gowns and sets performance requirements for these products. This document does not cover requirements for resistance to penetration by laser radiation of products. Suitable test methods for resistance to penetration by laser radiation, together with an appropriate classification system, are given in EN ISO 11810. This document does not cover requirements for incision drapes or films. This document does not cover requirements for antimicrobial treatments for surgical gowns and drapes. Antimicrobial treatment can cause environmental risks such as resistance and pollution. However, antimicrobial treated surgical gowns and drapes fall under the scope of this document with respect to their use as surgical gowns and drapes.
Extra information
Registration date
Date of withdrawal
CEN/TC 205/WG 14
ICS code
11.140 Hospital Equipment
Related to
EN 13795-1:2019, IDT
Health services - Hospital equipment - Hospitals - Coats - Surgical coverings - Medical devices - Regulations - Performance - Surgical clothes

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