NA 063

DIN Standards Committee Medicine

Standards [Withdrawn]

DIN EN 13795
Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels; German version EN 13795:2011+A1:2013

Title (German)

Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung zur Verwendung als Medizinprodukte für Patienten, Klinikpersonal und Geräte - Allgemeine Anforderungen für Hersteller, Wiederaufbereiter und Produkte, Prüfverfahren und Gebrauchsanforderungen; Deutsche Fassung EN 13795:2011+A1:2013

Overview

This consolidated version of DIN EN 13795 takes into account the essential requirements of the EC Directive 93/42/EEC on medical devices in the form currently required by the EU Commission. With respect to the previous edition from 2011, only Annex ZA was updated correspondingly. This document has been prepared by CEN/TC 205 "Non-active medical devices", the secretariat of which is held by DIN (Germany). The responsible German committee is NA 063-01-08 GA "Operationstextilien" ("Surgical textiles") at the Medical Standards Committee and the Textiles and Textile Machinery Standards Committee.

Document: references other documents

Document: referenced in other documents

Responsible national committee

NA 063-01-08 AA - Surgical textiles 

Responsible european committee

CEN/TC 205/WG 14 - Surgical clothing and drapes, and medical face masks 

Edition 2013-10
Original language German
Translation English
Price from 74.38 €
Table of contents

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