DIN Standards Committee Health Technologies
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
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 176-04-07 AA - Surgical textiles
Responsible european committee
CEN/TC 205/WG 14 - Surgical clothing and drapes, and medical face masks
