Norm

NEN-EN 13795-1:2017 Ontw. en

Kleding voor chirurgie en afdekmateriaal - Eisen en beproevingsmethoden - Deel 1: Chirugisch afdekmateriaal en operatiejassen

29,20

Over deze norm

Status Ontwerp
Aantal pagina's 30
Commissie Transfusie, infusie en injectieapparatuur voor medische toepassingen
Gepubliceerd op 01-06-2017
Taal Engels
This European Standard 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 European Standard 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 European Standard specifies test methods for evaluating the identified characteristics of surgical drapes and gowns and sets performance requirements for these products. prEN 13795-1 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. prEN 13795-1 does not cover requirements for incise drapes or films. prEN 13795-1 does not cover requirements for antimicrobial treatments for surgical gowns and drapes. Antimicrobial treatment may cause environmental risks such as resistance and pollution. However, antimicrobial treated surgical gowns and drapes fall under the scope of this standard with respect to their use as surgical gowns and drapes.

Details

ICS-code 11.140
Nederlandse titel Kleding voor chirurgie en afdekmateriaal - Eisen en beproevingsmethoden - Deel 1: Chirugisch afdekmateriaal en operatiejassen
Engelse titel Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
Vervangt
Normatieve verwijzingen
  • 2007/47/EG,

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