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  • NF EN 13795-1 : 2003 + A1 2009

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    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

    Available format(s): 

    Superseded date:  01-05-2011

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Association Francaise de Normalisation

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    Table of Contents - (Show below) - (Hide below)

    Avant-propos
    Introduction
    1 Domaine d'application
    2 Termes et définitions
    3 Informations à fournir par le fabricant ou par le prestataire
    4 Exigences relatives à la fabrication et au traitement
    5 Exigences relatives aux essais
    Annexe A (informative) Confort
    Annexe B (informative) Adhésifs de fixation et d'isolation de
             la plaie
    Annexe C (informative) Prévention des infections en salle
             d'opération
    Annexe ZA (informative) Relation entre la présente Norme
              européenne et les exigences essentielles de la
              Directive UE 93/42/CEE relative aux dispositifs
              médicaux
    Bibliographie

    Abstract - (Show below) - (Hide below)

    Provides information that to be supplied to users and third party verifiers, in addition to the usual labelling of medical devices, concerning manufacturing and processing requirements. It also 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.

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    Development Note Indice de classement: S97-165-1PR. Supersedes NFS 97 165-1. (09/2003) 2003 Edition Re-issued in September 2009 & incorporates AMD 1 2009. (09/2009) PR NF EN 13795-1 August 2017. (08/2017)
    Document Type Standard
    Publisher Association Francaise de Normalisation
    Status Superseded
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    FD S98 135 : 2005 FD STERILISATION OF MEDICAL DEVICES - GUIDELINES FOR THE CONTROL OF THE TREATMENTS APPLIED TO THE RE-USABLE MEDICAL DEVICES
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