NF EN 13795-1 : 2003 + A1 2009
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by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
12-01-2013
01-05-2011
Avant-propos
Introduction
1 Domaine d'application
2 Termes et définitions
3 Informations à fournir par le fabricant ou par le prestataire
4 Exigences relatives à la fabrication et au traitement
5 Exigences relatives aux essais
Annexe A (informative) Confort
Annexe B (informative) Adhésifs de fixation et d'isolation de
la plaie
Annexe C (informative) Prévention des infections en salle
d'opération
Annexe ZA (informative) Relation entre la présente Norme
européenne et les exigences essentielles de la
Directive UE 93/42/CEE relative aux dispositifs
médicaux
Bibliographie
Provides information that to be supplied to users and third party verifiers, in addition to the usual labelling of medical devices, concerning manufacturing and processing requirements. It also gives 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 |
Indice de classement: S97-165-1PR. Supersedes NFS 97 165-1. (09/2003) 2003 Edition Re-issued in September 2009 & incorporates AMD 1 2009. (09/2009) PR NF EN 13795-1 August 2017. (08/2017)
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| DocumentType |
Standard
|
| PublisherName |
Association Francaise de Normalisation
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| Status |
Superseded
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| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| ONORM EN 13795-1 : 2009 | Identical |
| NEN EN 13795-1 : 2002 + A1 2009 | Identical |
| NS EN 13795-1 : 2002 + A1 2009 | Identical |
| BS EN 13795-1 : 2002 | Identical |
| DIN EN 13795-1:2009-10 | Identical |
| I.S. EN 13795-1:2002 | Identical |
| NBN EN 13795-1 : 2003 + A1 2009 | Identical |
| EN 13795-1:2002+A1:2009 | Identical |
| UNE-EN 13795-1:2003 | Identical |
| FD S98 135 : 2005 FD | STERILISATION OF MEDICAL DEVICES - GUIDELINES FOR THE CONTROL OF THE TREATMENTS APPLIED TO THE RE-USABLE MEDICAL DEVICES |
| 2007/47/EC : 2007 COR 1 2015 | DIRECTIVE 2007/47/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL OF 5 SEPTEMBER 2007 AMENDING COUNCIL DIRECTIVE 1990/385/EEC ON THE APPROXIMATION OF THE LAWS OF THE MEMBER STATES RELATING TO ACTIVE IMPLANTABLE MEDICAL DEVICES, COUNCIL DIRECTIVE 1993/42/EEC CONCERNING MEDICAL DEVICES AND DIRECTIVE 1998/8/EC CONCERNING THE PLACING OF BIOCIDAL PRODUCTS ON THE MARKET(TEXT WITH EEA RELEVANCE) |
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