BS EN 13795-1 : 2002
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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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
English
01-01-2002
22-04-2019
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 infection in the
operating theatre
Annex ZA (informative) - Relationship between this European
Standard and the Essential
Requirements of EU Directive
93/42/EEC on Medical Devices
Bibliography
Provides information to be supplied to users and third party verifiers, in addition to the usual labelling of medical devices, concerning manufacturing and processing requirements.
| Committee |
CH/205/1
|
| DevelopmentNote |
Supersedes 99/566848 DC (12/2002) 2002 Edition Re-Issued in August 2009 & incorporates AMD 1 2009. (08/2009)
|
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
British Standards Institution
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| DIN EN 13795-1:2009-10 | Identical |
| NBN EN 13795-1 : 2003 + A1 2009 | Identical |
| I.S. EN 13795-1:2002 | Identical |
| EN 13795-1:2002+A1:2009 | Identical |
| NF EN 13795-1 : 2003 + A1 2009 | Identical |
| NEN EN 13795-1 : 2002 + A1 2009 | Identical |
| NS EN 13795-1 : 2002 + A1 2009 | Identical |
| UNE-EN 13795-1:2003 | Identical |