PREN 13795 : DRAFT 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS, TEST METHODS, PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS
01-03-2011
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Superseded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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