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

This European Standard specifies information to be supplied to users and third party verifiers in addition to the usual labelling of medical devices (see EN 980 and EN 1041), concerning manufacturing and processing requirements. This European Standard gives information 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, intended to prevent the transmission of infective agents between patients and clinical staff during surgical and other invasive procedures. This European Standard specifies test methods for evaluating the identified characteristics of surgical drapes, gowns and clean air suits and sets performance requirements for these products.
EN 13795 does not cover requirements for flammability of products. Suitable test methods for flammability and resistance to penetration by laser radiation, together with an appropriate classification system, are given in EN ISO 11810-1 and EN ISO 11810-2. Additional essential requirements that apply to surgical clothing and drapes are covered by other European Standards.

Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung zur Verwendung als Medizinprodukte für Patienten, Klinikpersonal und Geräte - Allgemeine Anforderungen für Hersteller, Wiederaufbereiter und Produkte, Prüfverfahren und Gebrauchsanforderungen

Diese Europäische Norm legt die Informationen fest, die dem Anwender und Prüfer (Dritte) zu liefern sind, zusätzlich zu der normalen Kennzeichnung von Medizinprodukten (siehe EN 980 und EN 1041) bezüglich Anforderungen an die Herstellung und Aufbereitung. Diese Europäische Norm gibt Aufschluss über die Eigenschaften von Einmal- und Mehrweg-Operationsmänteln, Abdecktüchern und Rein-Luft-Kleidung zur Verwendung als Medizinprodukte für Patienten, Klinikpersonal und Geräte, zum Schutz vor Übertragung infektiöser Agenzien zwischen Patienten und Klinikpersonal während operativer und anderer invasiver Eingriffe. Diese Europäische Norm legt Prüfverfahren zur Bewertung der bestimmten Eigenschaften von Operationsabdecktüchern, -mänteln und Rein-Luft-Kleidung sowie die Anforderungen an diese Produkte fest. EN 13795 befasst sich nicht mit Anforderungen an die Entflammbarkeit von Produkten. Geeignete Prüfverfahren für die Entflammbarkeit und den Widerstand gegen die Durchdringung durch Laserstrahlung, zusammen mit einer geeigneten Klassifizierung, sind in EN ISO 11810-1 und EN ISO 11810-2 angegeben. Zusätzliche grundlegende Anforderungen, die für Operationsmäntel und Operationsabdecktücher gelten, sind in weiteren Europäischen Normen festgelegt.

Champs chirurgicaux, casaques et tenues de bloc, utilisés en tant que dispositifs médicaux pour les patients, le personnel et les équipements - Exigences générales pour les fabricants, les prestataires et les produits, méthodes d'essai, exigences et niveaux de performance

La présente Norme européenne spécifie les informations à fournir aux utilisateurs et aux tiers effectuant les contrôles en plus de l’étiquetage usuel des dispositifs médicaux (voir l’EN 980 et l’EN 1041), concernant les exigences de fabrication et de traitement. La présente norme européenne fournit des informations sur les caractéristiques des champs chirurgicaux, casaques chirurgicales et tenues de bloc qu’ils soient à usage unique ou réutilisables utilisés en tant que dispositifs médicaux pour les patients, le personnel médical et les équipements et destinés à empêcher la transmission d’agents infectieux entre les patients et le personnel chirurgical au cours des interventions chirurgicales et autres interventions invasives. La présente Norme européenne spécifie les méthodes d’essai permettant d’évaluer les caractéristiques identifiées des champs chirurgicaux, casaques et tenues de bloc et établit les exigences de performance pour ces produits.
L’EN 13795 n’aborde pas les exigences relatives à l’inflammabilité des produits. Les méthodes d’essai appropriées à l’inflammabilité et à la résistance à la pénétration par rayonnement laser, ainsi qu’un système de classification adéquat, sont traités dans l’EN ISO 11810-1 et l'EN ISO 11810-2. D’autres exigences essentielles applicables aux vêtements et aux champs chirurgicaux sont traitées par d’autres normes européennes.

Operacijska pokrivala, pregrinjala in plašči ter čista oblačila, ki se uporabljajo kot medicinski pripomočki za paciente, zdravstveno osebje in opremo - Splošne zahteve za proizvajalce, predelovalce in izdelke, preskusne metode, zahtevane lastnosti in zahtevane stopnje

Ta evropski standard določa informacije, ki jih je treba priskrbeti uporabnikom in preveriteljem tretje strani poleg običajnega označevanja medicinskih pripomočkov (glej EN 980 in EN 1041), ki zadevajo zahteve za proizvodnjo in obdelavo. Ta evropski standard podaja informacije o značilnostih operacijskih plaščev za enkratno ali večkratno uporabo, operacijskih pregrinjal in čistih oblačil, ki se uporabljajo kot medicinski pripomočki za bolnike, zdravstveno osebje in opremo, in so namenjeni preprečevanju prenosa povzročiteljev okužb med bolniki in zdravstvenim osebjem pri operacijskih ali drugih invazivnih posegih. Ta evropski standard določa preskusne metode za ocenjevanje ugotovljenih značilnosti operacijskih pregrinjal, plaščev in čistih oblačil ter postavlja zahteve za zmogljivost za te proizvode. EN 13795 ne zajema zahtev za gorljivost proizvodov. Ustrezne preskusne metode za gorljivost in odpornost proti penetraciji laserskega sevanja, skupaj s primernim klasifikacijskim sistemom, so podane v EN ISO 11810-1 in EN ISO 11810-2. Dodatne bistvene zahteve, ki veljajo za operacijska oblačila in pregrinjala, so zajete v drugih evropskih standardih.

General Information

• Status: Withdrawn
• Publication Date: 15-Mar-2011
• Withdrawal Date: 05-Feb-2013
• 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: 9960 - Withdrawal effective - Withdrawal
• Start Date: 06-Feb-2013
• Completion Date: 06-Feb-2013
• 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 13795:2011 - 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

Relations

• Replaces: 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
• Effective Date: 08-Jun-2022
• Replaces: 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: 15-Aug-2009
• Replaces: 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: 15-Aug-2009
• Merged Into: EN 13795:2011+A1:2013 - 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: 19-Jan-2023
• Revised: EN 13795-1:2019 - Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
• Effective Date: 14-Dec-2011
• Revised: EN 13795-2:2019 - Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
• Effective Date: 14-Dec-2011
• Revised: 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
• Revised: 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: 22-Dec-2008
• Revised: 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
• Parent: 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
• Parent: 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: 22-Dec-2008
• Parent: 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)

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 - Allgemeine Anforderungen für Hersteller, Wiederaufbereiter und Produkte, Prüfverfahren und GebrauchsanforderungenChamps chirurgicaux, casaques et tenues de bloc, utilisés en tant que dispositifs médicaux pour les patients, le personnel et les equipments - Exigences générales pour les fabricants, les prestataires et les produits, methods de test, prescriptionsSurgical 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 levels11.140Oprema bolnišnicHospital equipmentICS:Ta slovenski standard je istoveten z:EN 13795:2011SIST EN 13795:2011en,fr,de01-julij-2011SIST EN 13795:2011SLOVENSKI
STANDARDSIST EN 13795-3:2006+A1:2009SIST EN 13795-2:2005+A1:2009SIST EN 13795-1:2003+A1:20091DGRPHãþD

EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 13795
March 2011 ICS 11.140 Supersedes EN 13795-1:2002+A1:2009, EN 13795-2:2004+A1:2009, EN 13795-3:2006+A1:2009English Version
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
Champs chirurgicaux, casaques et tenues de bloc, utilisés en tant que dispositifs médicaux pour les patients, le personnel et les équipements - Exigences générales pour les fabricants, les prestataires et les produits, méthodes d'essai, exigences et niveaux de performance
Operationsabdecktücher, -mäntel und Rein-Luft-Kleidung zur Verwendung als Medizinprodukte für Patienten, Klinikpersonal und Geräte - Allgemeine Anforderungen für Hersteller, Wiederaufbereiter und Produkte, Prüfverfahren und Gebrauchsanforderungen This European Standard was approved by CEN on 5 February 2011.
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-CENELEC 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-CENELEC Management Centre has the same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, 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 © 2011 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13795:2011: ESIST EN 13795:2011

Details of significant changes between this European Standard and the previous edition . 13Annex B (normative)
Test methods . 15Annex C (informative)
Prevention of infection in the operating room . 17Annex D (informative)
Information on further characteristics . 18Annex ZA (informative)
Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC . 20Bibliography . 22 SIST EN 13795:2011

EN 13795-3:2006+A1:2009. This document has been prepared under a mandate given to CEN by the European Commission and the European Free Trade Association. For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document. Annex A provides details of significant changes between this European Standard and the previous edition represented by the three parts mentioned above. 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, Croatia, 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 the United Kingdom.
EN ISO 139, Textiles — Standard atmospheres for conditioning and testing (ISO 139:2005) EN ISO 9073-10, Textiles — Test methods for nonwovens — Part 10: Lint and other particles generation in the dry state (ISO 9073-10:2003) EN ISO 11737-1:2006, Sterilization of medical devices — Microbiological methods — Part 1: Determination of a population of microorganisms on products (ISO 11737-1:2006) EN ISO 13938-1, Textiles — Bursting properties of fabrics — Part 1: Hydraulic method for determination of bursting strength and bursting distension (ISO 13938-1:1999) 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) 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 cfu (colony forming unit) unit by which the culturable number of microorganisms is expressed NOTE The culturable number is the number of microorganisms, single cells or aggregates, able to form colonies on a solid nutrient medium. SIST EN 13795:2011
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