EN 13795-2:2004/FprA1

Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods

Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung zur Verwendung als Medizinprodukte für Patienten, Klinikpersonal und Geräte - Teil 2: Prüfverfahren

Champs chirurgicaux, casaques et tenues de bloc, utilisés en tant que dispositifs médicaux pour les patients, le personnel et les équipements - Partie 2 : Méthodes d'essai

Operacijska pokrivala, pregrinjala in plašči ter čista oblačila, ki se uporabljajo kot medicinski pripomočki za paciente, zdravstveno osebje in opremo - 2. del: Preskusne metode

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 13795-2:2005/kprA1:2009 - Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods

Relations

• Merged Into: EN 13795-2:2004+A1:2009 - Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods
• Effective Date: 30-May-2009
• Amends: EN 13795-2:2004 - Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 2: Test methods
• Effective Date: 22-Dec-2008

Standards Content (Sample)

SLOVENSKI STANDARD
01-april-2009
2SHUDFLMVNDSRNULYDODSUHJULQMDODLQSODãþLWHUþLVWDREODþLODNLVHXSRUDEOMDMRNRW
PHGLFLQVNLSULSRPRþNL]DSDFLHQWH]GUDYVWYHQRRVHEMHLQRSUHPRGHO
3UHVNXVQHPHWRGH
Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical
staff and equipment - Part 2: Test methods
Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung zur Verwendung als
Medizinprodukte für Patienten, Klinikpersonal und Geräte - Teil 2: Prüfverfahren
Champs chirurgicaux, casaques et tenues de blocs, utilisés comme dispositifs médicaux,
pour les patients, le personnel médical et les équipements - Partie 2: Méthodes d'essai
Ta slovenski standard je istoveten z: EN 13795-2:2004/FprA1
ICS:
11.140 Oprema bolnišnic Hospital equipment
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
FINAL DRAFT
EN 13795-2:2004
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 2: Test
methods
Champs chirurgicaux, casaques et tenues de blocs, utilisés Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung
comme dispositifs médicaux, pour les patients, le zur Verwendung als Medizinprodukte für Patienten,
personnel médical et les équipements - Partie 2: Méthodes Klinikpersonal und Geräte - Teil 2: Prüfverfahren
d'essai
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 13795-2:2004. 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 FO
...