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Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
24-03-2011
English
01-01-2002
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.
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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Superseded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 |
| SN EN 13795-1 : 2003 + A1 2009 | Identical |
| UNI EN 13795-1 : 2009 | Identical |
| UNE-EN 13795-1:2003 | Identical |
| BS EN 13795-1 : 2002 | Identical |
| EN 13795-1:2002+A1:2009 | Identical |
| ISO 13488:1996 | Quality systems — Medical devices — Particular requirements for the application of ISO 9002 |
| EN 1174-3 : 1996 | STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - GUIDE TO THE METHODS FOR VALIDATION OF MICROBIOLOGICAL TECHNIQUES |
| EN ISO 13488 : 2000 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002 |
| EN 46001 : 1996 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001 |
| EN ISO 9237:1995 | Textiles - Determination of permeability of fabrics to air (ISO 9237:1995) |
| ISO 13485:2016 | Medical devices Quality management systems Requirements for regulatory purposes |
| EN 724 : 1994 | GUIDANCE ON THE APPLICATION OF EN 29001 AND EN 46001 AND OF EN 29002 AND EN 46002 FOR NON-ACTIVE MEDICAL DEVICES |
| EN 1174-1 : 1996 | STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - REQUIREMENTS |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| EN 1174-2 : 1996 | STERILIZATION OF MEDICAL DEVICES - ESTIMATION OF THE POPULATION OF MICRO-ORGANISMS ON PRODUCT - GUIDANCE |
| EN ISO 11810:2015 | Lasers and laser-related equipment - Test method and classification for the laser resistance of surgical drapes and/or patient protective covers - Primary ignition, penetration, flame spread and secondary ignition (ISO 11810:2015) |
| ISO 11092:2014 | Textiles — Physiological effects — Measurement of thermal and water-vapour resistance under steady-state conditions (sweating guarded-hotplate test) |
| EN 46002 : 1996 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002 |
| EN 980:2008 | Symbols for use in the labelling of medical devices |
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