EN 13795-1:2002/FprA1

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

2009-02-25 EMA: Work item 00205206 was deleted because its content is included into work item 00205203.

Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung zur Verwendung als Medizinprodukte für Patienten, Klinikpersonal und Geräte - Teil 1: Allgemeine Anforderungen für Hersteller, Aufbereiter und Produkte

Champs chirurgicaux, casaques et tenues de bloc, utilisés en tant que dispositifs médicaux pour les patients, le personnel et les équipements - Partie 1: Exigences générales pour les fabricants, les prestataires et les produits

Operacijska pokrivala, pregrinjala in plašči ter čista oblačila, ki se uporabljajo kot medicinski pripomočki za paciente, zdravstveno osebje in opremo - 1. del: Splošne zahteve za proizvajalce, predelovalce in izdelke

General Information

• Status: Not Published
• ICS: 11.140 - Hospital equipment
• Technical Committee: CEN/TC 205 - Non-active medical devices
• Drafting Committee: CEN/TC 205/WG 14 - Surgical clothing and drapes used as medical devices in health care facilities - Performance requirements and test methods
• Current Stage: 5060 - Closure of Vote - Formal Approval
• Start Date: 12-May-2009
• Completion Date: 12-May-2009
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Mandate: M/295 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN 13795-1:2003/kprA1:2009 - 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

Relations

• Merged Into: EN 13795-1:2002+A1:2009 - 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
• Effective Date: 30-May-2009
• Amends: EN 13795-1:2002 - 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
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN 13795-1:2003/kprA1:2009
01-april-2009
2SHUDFLMVNDSRNULYDODSUHJULQMDODLQSODãþLWHUþLVWDREODþLODNLVHXSRUDEOMDMRNRW
PHGLFLQVNLSULSRPRþNL]DSDFLHQWH]GUDYVWYHQRRVHEMHLQRSUHPRGHO6SORãQH
]DKWHYH]DSURL]YDMDOFHSUHGHORYDOFHLQL]GHONH
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
Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung zur Verwendung als
Medizinprodukte für Patienten, Klinikpersonal und Geräte - Teil 1: Allgemeine
Anforderungen für Hersteller, Aufbereiter und Produkte
Champs chirurgicaux, casaques et tenues de bloc, utilisés en tant que dispositifs
médicaux, pour les patients, le personnel et les équipements - Partie 1: Exigences
générales pour les fabricants, les prestataires et les produits
Ta slovenski standard je istoveten z: EN 13795-1:2002/FprA1
ICS:
11.140 Oprema bolnišnic Hospital equipment
SIST EN 13795-1:2003/kprA1:2009 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN 13795-1:2003/kprA1:2009

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SIST EN 13795-1:2003/kprA1:2009
EUROPEAN STANDARD
FINAL DRAFT
EN 13795-1:2002
NORME EUROPÉENNE
EUROPÄISCHE NORM
FprA1
February 2009
ICS 11.140

English Version
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
Champs chirurgicaux, casaques et tenues de bloc, utilisés Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung
en tant que dispositifs médicaux, pour les patients, le zur Verwendung als Medizinprodukte für Patienten,
personnel et les équipements - Partie 1: Exigences Klinikpersonal und Geräte - Teil 1: Allgemeine
générales pour les fabricants, les prestataires et les Anforderungen für Hersteller, Aufbereiter und Produkte
produits
This draft amendment is submitted to CEN members for unique acceptance procedure. It has been drawn up by the Technical Committee
CEN/TC 205.
This draft amendment A1, if approved, will modify the European Standard EN 13795-1:2002. If this draft becomes an amendment, CEN
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this amendment
into the relevant national standard without any alteration.
This draft amendment was established by CEN in three official versions (English, French, German). A version in any other language made
by translation under the responsibility of a CEN member into its own language and notified to the CEN Management Centre has the same
status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN 13795-1:2002/FprA1:2009: E
worldwide for CEN national Members.

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SIST EN 13795-1:2003/kprA1:2009
EN 13795-1:2002/FprA1:2009 (E)
Foreword
This document (EN 13795-1:2002/FprA1:2009) has been prepared by Technical Committee CEN/TC 205
“Non-active medical devices”, the secretariat of which is held by DIN.
This document is currently submitted to the Unique Acceptance Procedure.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EC Directive(s).
For relationship with EC Directive(s), see informative Annex ZA, which is an integral part of this document.
2

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SIST EN 13795-1:2003/kprA1:2009
EN 13795-1:2002/FprA1:2009 (E)
1 Modification to the Introduction
nd
Replace the 2 paragraph with the following:
"Surgical drapes, including the intended use as a sterile field, gowns and clean air suits are used to minimize
the spread of infective agents to and from patients’ operating wounds, thereby helping to prevent post-
operative wound infections (see Annex C)."
2 Modification to Clause 2
Add the following new definition 2.15 and renumber the subsequent definitions accordingly:
"
2.15
sterile field
area cr
...