UNE-EN 13795-1:2003
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
View Superseded by
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
Hardcopy , PDF
22-03-2010
Spanish, Castilian
13-06-2003
Important note : Users cannot be edited or removed once added to your Multi user PDF.
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.
| Committee |
CTN 111
|
| DevelopmentNote |
2003 Edition Re-Issued in January 2010 & incorporates AMD 1 2010. (01/2010)
|
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
Asociacion Espanola de Normalizacion
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| BS EN 13795-1 : 2002 | Identical |
| SN EN 13795-1 : 2003 + A1 2009 | Identical |
| DIN EN 13795-1:2009-10 | Identical |
| NF EN 13795-1 : 2003 + A1 2009 | Identical |
| I.S. EN 13795-1:2002 | Identical |
| NEN EN 13795-1 : 2002 + A1 2009 | Identical |
| UNI EN 13795-1 : 2009 | Identical |
| NS EN 13795-1 : 2002 + A1 2009 | Identical |
| EN 13795-1:2002+A1:2009 | Identical |
| NBN EN 13795-1 : 2003 + A1 2009 | Identical |
Access your standards online with a subscription
Features
-
Simple online access to standards, technical information and regulations.
-
Critical updates of standards and customisable alerts and notifications.
-
Multi-user online standards collection: secure, flexible and cost effective.