I.S. 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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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
24-03-2011
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
Dates of withdrawal of national standards are available from NSAI.
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
Describes information to be supplied to users and third party verifiers, in addition to the usual labeling of medical devices, concerning manufacturing and processing requirements. Also provides 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 |
2002 Edition Re-Issued in September 2009 & incorporates AMD 1 2009. (09/2009)
|
| DocumentType |
Standard
|
| Pages |
17
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy |
| Standards | Relationship |
| NF EN 13795-1 : 2003 + A1 2009 | Identical |
| DIN EN 13795-1:2009-10 | Identical |
| NBN EN 13795-1 : 2003 + A1 2009 | Identical |
| NEN EN 13795-1 : 2002 + A1 2009 | Identical |
| NS EN 13795-1 : 2002 + A1 2009 | Identical |
| BS EN 13795-1 : 2002 | Identical |
| EN 13795-1:2002+A1:2009 | Identical |
| UNE-EN 13795-1:2003 | Identical |
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