SIST EN 13795-3:2006+A1:2009

Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels

This part of the series of EN 13795 specifies performance requirements for surgical drapes, gowns and clean air suits.
NOTE   General performance requirements are specified for various characteristics as per EN 13795-1:2002 Tables 1, 2 and 3 and should be evaluated according to EN 13795-2, EN ISO 22610 and EN ISO 22612.

Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung zur Verwendung als Medizinprodukte für Patienten, Klinikpersonal und Geräte - Teil 3: Gebrauchsanforderungen und Leistungsstufen

Dieser Teil der Normenreihe EN 13795 legt Gebrauchsanforderungen an Operationsabdecktücher, -mäntel
und Rein-Luft-Kleidung fest.
ANMERKUNG Allgemeine Gebrauchsanforderungen für unterschiedliche Eigenschaften sind in EN 13795-1:2002,
Tabellen 1, 2 und 3 festgelegt und sollten nach EN 13795-2, EN ISO 22610 und EN ISO 22612 bewertet werden.

Champs chirurgicaux, casaques et tenues de bloc utilisés en tant que dispositifs médicaux pour les patients, le personnel et les équipements - Partie 3: Exigences et niveaux de performance

Le présent document (EN 13795-3:2006+A1:2009) a été élaboré par le Comité Technique CEN/TC 205 «Dispositifs
médicaux non actifs», dont le secrétariat est tenu par le DIN.
Cette Norme européenne devra recevoir le statut de norme nationale, soit par publication d'un texte identique,
soit par entérinement, au plus tard en janvier 2010, et toutes les normes nationales en contradiction devront être
retirées au plus tard en mars 2010.
Le présent document comprend l’Amendement 1, approuvé par le CEN le 2009-06-13.
Le présent document remplace l’EN 13795-3:2006.
Le début et la fin du texte ajouté ou modifié par l’amendement est indiqué dans le texte par les repères !".
Le présent document a été élaboré dans le cadre d'un mandat donné au CEN par la Commission Européenne et
l'Association Européenne de Libre Échange et vient à l'appui des exigences essentielles de la (de) Directive(s) CE.
Pour la relation avec la (les) Directive(s) CE, voir l'Annexe ZA, informative, qui fait partie intégrante du présent
document.
L’EN 13795 doit être constituée des parties suivantes rassemblées sous le titre général «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
- Partie 2 : Méthodes d’essai
- Partie 3 : Exigences et niveaux de performance.
L’attention est également appelée sur les documents suivants :
- EN ISO 22610, Champs chirurgicaux, casaques et tenues de bloc, utilisés en tant que dispositifs médicaux, pour
les patients, le personnel et les équipements — Méthode d’essai de résistance à la pénétration de la barrière
bactérienne à l’état humide (ISO 22610:2006) ;
- EN ISO 22612, Vêtements de protection contre les agents infectieux — Méthode d’essai pour la résistance
à la pénétration microbienne par voie sèche (ISO 22612:2005).
Selon le Règlement Intérieur du CEN/CENELEC, les instit

Operacijska pokrivala, pregrinjala in plašči ter čista oblačila, ki se uporabljajo kot medicinski pripomočki za paciente, zdravstveno osebje in opremo - 3. del: Zahtevane lastnosti in zahtevane stopnje

General Information

• Status: Withdrawn
• Publication Date: 12-Oct-2009
• Withdrawal Date: 31-May-2011
• ICS: 11.140 - Hospital equipment
• Technical Committee: VAZ - Healthcare
• Current Stage: 9900 - Withdrawal (Adopted Project)
• Start Date: 01-Jun-2011
• Due Date: 24-Jun-2011
• Completion Date: 01-Jun-2011
• 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: EN 13795-3:2006+A1:2009 - Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels

Relations

• Consolidates: SIST EN 13795-3:2006/kprA1:2009 - Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels
• Effective Date: 01-Nov-2009
• Consolidates: SIST EN 13795-3:2006 - Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels
• Effective Date: 01-Nov-2009
• Replaced By: SIST EN 13795:2011 - Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
• Effective Date: 01-Jul-2011
• Replaced By: SIST EN 13795:2011 - Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - General requirements for manufacturers, processors and products, test methods, performance requirements and performance levels
• Effective Date: 08-Jun-2022
• Consolidates: SIST EN 13795-3:2006/kprA1:2009 - Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels
• Effective Date: 18-Jan-2023
• Consolidates: SIST EN 13795-3:2006 - Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels
• Effective Date: 19-Jan-2023
• Consolidates: SIST EN 13795-3:2006/kprA1:2009 - Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels
• Effective Date: 19-Jan-2023
• Consolidates: SIST EN 13795-3:2006 - Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels
• Effective Date: 18-Jan-2023

Standards Content (Sample)

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung zur Verwendung als Medizinprodukte für Patienten, Klinikpersonal und Geräte - Teil 3: Gebrauchsanforderungen und LeistungsstufenChamps chirurgicaux, casaques et tenues de bloc utilisés en tant que dispositifs médicaux pour les patients, le personnel et les équipements - Partie 3: Exigences et niveaux de performanceSurgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels11.140Oprema bolnišnicHospital equipmentICS:Ta slovenski standard je istoveten z:EN 13795-3:2006+A1:2009SIST EN 13795-3:2006+A1:2009en,fr,de01-november-2009SIST EN 13795-3:2006+A1:2009SLOVENSKI
STANDARD



SIST EN 13795-3:2006+A1:2009



EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 13795-3:2006+A1
July 2009 ICS 11.140 Supersedes EN 13795-3:2006English Version
Surgical drapes, gowns and clean air suits, used as medical devices for patients, clinical staff and equipment - Part 3: Performance requirements and performance levels
Champs chirurgicaux, casaques et tenues de bloc utilisés en tant que dispositifs médicaux pour les patients, le personnel et les équipements - Partie 3: Exigences et niveaux de performance
Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung zur Verwendung als Medizinprodukte für Patienten, Klinikpersonal und Geräte - Teil 3: Gebrauchsanforderungen und Leistungsstufen This European Standard was approved by CEN on 27 April and includes Amendment 1 approved by CEN on13 June 2009.
CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN Management Centre or to any CEN member.
This European Standard exists 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.
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 worldwide for CEN national Members. Ref. No. EN 13795-3:2006+A1:2009: ESIST EN 13795-3:2006+A1:2009



EN 13795-3:2006+A1:2009 (E) 2 Contents
Page Foreword . 3Introduction . 41Scope . 52Normative references . 53Terms and definitions . 54Performance requirements . 6Annex ZA (informative)
!!!!Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices"""" . 10Bibliography . 11 SIST EN 13795-3:2006+A1:2009



EN 13795-3:2006+A1:2009 (E) 3 Foreword This document (EN 13795-3:2006+A1:2009) has been prepared by Technical Committee CEN/TC 205 “Non-active medical devices”, the secretariat of which is held by DIN. This European Standard shall be given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by January 2010, and conflicting national standards shall be withdrawn at the latest by March 2010. This document includes Amendment 1, approved by CEN on 2009-06-13. This document supersedes EN 13795-3:2006. The start and finish of text introduced or altered by amendment is indicated in the text by tags !". 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 EU Directive(s). For relationship with EU Directive, see informative Annex ZA, which is an integral part of this document. EN 13795 consists of the following parts under the general title “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 Part 2: Test methods Part 3: Performance requirements and performance levels Attention is also drawn to the following: EN ISO 22610 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Test method to determine the resistance to wet bacterial penetration (ISO 22610:2006) EN ISO 22612 Clothing for protection against infectious agents — Test method for resistance to dry microbial penetration (ISO 22612:2005) According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: 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. SIST EN 13795-3:2006+A1:2009



EN 13795-3:2006+A1:2009 (E) 4 Introduction The series of EN 13795 specifies requirements for single-use and reusable coverings (i. e. surgical gowns, surgical drapes and clean air suits) used as medical devices for patients, clinical staff and equipment and intended to prevent the transmission of infective agents between patients and clinical staff during invasive surgical procedures. General requirements for surgical drapes, gowns and clean air suits, used as medical devices, for patients clinical staff and equipment are specified in EN 13795-1. In this respect EN 13795-1 specifies the relevant characteristics to be evaluated for products covered by this European Standard. EN 13795-2 specifies test methods for evaluating these characteristics. NOTE For more information on products contained within the scope of this European Standard it is recommended to refer to EN 13795-1. SIST EN 13795-3:2006+A1:2009



EN 13795-3:2006+A1:2009 (E) 5 1 Scope This part of the series of EN 13795 specifies performance requirements for surgical drapes, gowns and clean air suits. NOTE General performance requirements are specified for various characteristics as per EN 13795-1:2002 Tables 1, 2 and 3 and should be evaluated according to EN 13795-2, EN ISO 22610 and EN ISO 22612.
2 Normative references The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. EN 13795-1, 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 EN 13795-2, Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment — Part 2: Test methods EN ISO 22610, Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff, and equipment - Test method to determine the resistance to wet bacterial penetration (ISO 22610:2006) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 less critical product area product area less likely to be involved in the transf
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