NEN EN 13795-1 : 2002 + A1 2009
Withdrawn
View Superseded by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
01-12-2013
03-24-2011
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
Defines information to be supplied to users and third party verifiers, in addition to the usual labelling of medical devices, concerning manufacturing and processing requirements.
| DevelopmentNote |
2002 Edition Re-Issued in July 2009 & incorporates AMD 1 2009. (08/2009) Draft issued in June 2017. (07/2017)
|
| DocumentType |
Standard
|
| PublisherName |
Netherlands Standards
|
| Status |
Withdrawn
|
| SupersededBy |
| Standards | Relationship |
| BS EN 13795-1 : 2002 | Identical |
| DIN EN 13795-1:2009-10 | Identical |
| NF EN 13795-1 : 2003 + A1 2009 | Identical |
| I.S. EN 13795-1:2002 | Identical |
| NBN EN 13795-1 : 2003 + A1 2009 | Identical |
| NS EN 13795-1 : 2002 + A1 2009 | Identical |
| EN 13795-1:2002+A1:2009 | Identical |
| UNE-EN 13795-1:2003 | Identical |