• NEN EN 13795-1 : 2002 + A1 2009

    Withdrawn A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.

    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): 

    Withdrawn date:  24-03-2011

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Netherlands Standards

    Sorry this product is not available in your region.

    Add To Cart

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

    Foreword
    Introduction
    1 Scope
    2 Terms and definitions
    3 Information to be supplied by the manufacturer or
      processor
    4 Manufacturing and processing requirements
    5 Testing requirements
    Annex A (informative) Comfort
    Annex B (informative) Adhesion for fixation and wound
            isolation
    Annex C (informative) Prevention of indication in the
            operating theatre
    Annex ZA (informative) Clauses of this European Standard
             addressing essential requirements or other
             provisions of EU Directives
    Bibliography

    Abstract - (Show below) - (Hide below)

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

    General Product Information - (Show below) - (Hide below)

    Development Note 2002 Edition Re-Issued in July 2009 & incorporates AMD 1 2009. (08/2009) Draft issued in June 2017. (07/2017)
    Document Type Standard
    Publisher Netherlands Standards
    Status Withdrawn
    Superseded By
    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective