NBN EN 13795-1 : 2003 + A1 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 - PART 1: GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS
01-05-2011
12-01-2013
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
Provides information that to be supplied to users and third party verifiers, in addition to the usual labelling of medical devices, concerning manufacturing and processing requirements. It also gives general guidance 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.
| DevelopmentNote |
2003 Edition Re-issued in October 2009 & incorporates AMD 1 2009. (11/2009)
|
| DocumentType |
Standard
|
| PublisherName |
Belgian Standards
|
| Status |
Superseded
|
| Standards | Relationship |
| EN 13795-1:2002+A1:2009 | Identical |
| NEN EN 13795-1 : 2002 + A1 2009 | Identical |
| UNE-EN 13795-1:2003 | Identical |
| SN EN 13795-1 : 2003 + A1 2009 | Identical |
| UNI EN 13795-1 : 2009 | Identical |
| DIN EN 13795-1:2009-10 | Identical |
| BS EN 13795-1 : 2002 | Identical |
| I.S. EN 13795-1:2002 | Identical |
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