DIN EN 13795-1:2009-10
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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
31-05-2019
English
01-01-2009
Vorwort
Einleitung
1 Anwendungsbereich
2 Begriffe
3 Vom Hersteller oder Aufbereiter zu
liefernde Informationen
4 Anforderungen an die Herstellung und
Aufbereitung
5 Anforderungen an die Prüfungen
Anhang A (informativ) Komfort
Anhang B (informativ) Fixierung und
Keimisolierung der Wunde
Anhang C (informativ) Infektionsprophylaxe
im Operationssaal
Anhang ZA (informativ) Zusammenhang zwischen dieser
Europäischen Norm und den grundlegenden
Anforderungen der EG-Richtlinie 93/42/EWG
über Medizinprodukte
Literaturhinweise
This standard is included in DIN Handbook 475.
| DevelopmentNote |
DRAFT 2017 issued in July 2017. (07/2017)
|
| DocumentType |
Standard
|
| Pages |
17
|
| PublisherName |
German Institute for Standardisation (Deutsches Institut für Normung)
|
| Status |
Superseded
|
| Standards | Relationship |
| BS EN 13795-1 : 2002 | Identical |
| NBN EN 13795-1 : 2003 + A1 2009 | Identical |
| NF EN 13795-1 : 2003 + A1 2009 | Identical |
| NEN EN 13795-1 : 2002 + A1 2009 | Identical |
| UNI EN 13795-1 : 2009 | Identical |
| NS EN 13795-1 : 2002 + A1 2009 | Identical |
| EN 13795-1:2002+A1:2009 | Identical |
| SN EN 13795-1 : 2003 + A1 2009 | Identical |
| EN 13795-1:2019 | Identical |
| UNE-EN 13795-1:2003 | Identical |
| I.S. EN 13795-1:2002 | 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 14065:2016 | Textiles - Laundry processed textiles - Biocontamination control system |
| 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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