I.S. EN 13795:2011
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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SURGICAL DRAPES, GOWNS AND CLEAN AIR SUITS, USED AS MEDICAL DEVICES FOR PATIENTS, CLINICAL STAFF AND EQUIPMENT - GENERAL REQUIREMENTS FOR MANUFACTURERS, PROCESSORS AND PRODUCTS, TEST METHODS, PERFORMANCE REQUIREMENTS AND PERFORMANCE LEVELS
Hardcopy , PDF
English
01-01-2011
06-04-2020
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 Normative references
3 Terms and definitions
4 Performance requirements
5 Testing
6 Manufacturing and processing requirements
7 Information to be supplied by the manufacturer
or processor
Annex A (informative) - Details of significant changes
between this European Standard and the previous
edition
Annex B (normative) - Test methods
Annex C (informative) - Prevention of infection in the
operating room
Annex D (informative) - Information on further
characteristics
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 labelling of medical devices, concerning manufacturing and processing requirements.
| DevelopmentNote |
Supersedes I.S. EN 13795-1, I.S. EN 13795-2 and I.S. EN 13795-3. (03/2011) 2011 Edition Re-Issued in February 2013 & incorporates AMD 1 2013. (02/2013)
|
| DocumentType |
Standard
|
| Pages |
25
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN 13795:2011+A1:2013 | Identical |
| EN 13795:2011 | Equivalent |
| DIN EN 13795:2011-06 | Equivalent |
| BS EN 13795:2011+A1:2013 | Equivalent |
| UNE-EN 13795:2011 | Equivalent |
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