Norm

NEN-EN 13795-1:2019 en

Chirurgische kleding en afdekmateriaal - Eisen en beproevingsmethoden - Deel 1: Chirurgisch afdekmateriaal en operatiejassen

62,00 75,02 Incl BTW

Over deze norm

Status Definitief
Aantal pagina's 33
Commissie OK-jassen en afdekmaterialen
Gepubliceerd op 01-04-2019
Taal Engels
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.

Details

ICS-code 11.140
Nederlandse titel Chirurgische kleding en afdekmateriaal - Eisen en beproevingsmethoden - Deel 1: Chirurgisch afdekmateriaal en operatiejassen
Engelse titel Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
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