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PREN 13795 : DRAFT 2009

Superseded

Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS, TEST METHODS, PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS

Superseded date

01-03-2011

Published date

12-01-2013

Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Performance requirements
5 Testing
6 Manufacturing and processing requirements
7 Information to be supplied by the manufacturer or
   processor
Annex A (informative) - Details of significant changes
        between this European Standard and the previous
        edition
Annex B (normative) - Test methods
Annex C (informative) - Prevention of infection in the
        operating room
Annex D (informative) - Information on further characteristics
Annex ZA (informative) - Relationship between this European
         Standard and the Essential Requirements of EU
         Directive 93/42/EEC
Bibliography

Provides information 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, intended to prevent the transmission of infective agents between patients and clinical staff during surgical and other invasive procedures. It also specifies test methods for evaluating the identified characteristics of surgical drapes, gowns and clean air suits and sets performance requirements for these products.

Committee
TC 205
DocumentType
Draft
PublisherName
Comite Europeen de Normalisation
Status
Superseded

Standards Relationship
DIN EN 13795:2013-10 Identical
09/30190221 DC : 0 Identical

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