Standard

NEN-EN 13795-1:2002+A1:2009 en

Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products

  • This norm is withdrawn since 24-03-2011

50,00 60,50 Incl BTW

About norm

Status Withdrawn
Number of pages 15
Committee OK-jassen en afdekmaterialen
Published on 01-07-2009
Language English
This standard specifies information to be supplied to users and third party verifiers, in addition to the usual labelling of medical devices (see EN 980 and EN 1041), concerning manufacturing and processing requirements. This standard gives general guidance on the characteristics of single-use and reusable surgical gowns, surgical drapes and clean air suits used as medical devices for patients, clinical staff and equipment. It is intended to prevent the transmission of infective agents between patients and clinical staff during surgical and other invasive procedures. Surgical masks, surgical gloves, packaging materials, foot and head wear and incision drapes are not covered by EN 13795. Requirements for medical gloves are given in the EN 455 series of European Standards and packaging materials are covered by the EN 868 series. Requirements for surgical masks and head coverings will be specified in future CEN/TC 205 standards.

Details

ICS-code 11.140
Dutch title Chirurgisch afdekmateriaal, operatiejassen en clean air suits, gebruikt als medische hulpmiddelen voor patienten, klinisch personeel en apparatuur - Deel 1: Algemene eisen voor fabrikanten, bewerkers en producten
English title Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Part 1: General requirements for manufacturers, processors and products
Replaces
Replaced in future

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