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

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 (vključno z dopolnilom A1)

Ta evropski standard določa informacije, ki jih je treba poleg običajnega označevanja medicinskih pripomočkov (glej standarda EN 980 in EN 1041) podati uporabnikom in tretjim strankam, ki izvajajo preverjanje, in sicer v zvezi z zahtevami za proizvodnjo in obdelovanje. Ta evropski standard podaja informacije o lastnostih operacijskih plaščev, pregrinjal in pokrival ter čistih oblačil za enkratno in večkratno uporabo, ki se uporabljajo kot medicinski pripomočki za paciente, zdravstveno osebje in opremo ter so namenjeni za preprečevanje prenosa infekcijskih agentov med pacienti in zdravstvenim osebjem med kirurškimi in drugimi invazivnimi postopki. Ta evropski standard določa preskusne metode za ocenjevanje identificiranih lastnosti operacijskih pokrival, pregrinjal in plaščev ter čistih oblačil in določa zahteve glede zmogljivosti teh proizvodov. Standard EN 13795 ne zajema zahtev za vnetljivost proizvodov. Ustrezne preskusne metode za vnetljivost in odpornost na penetracijo z laserskim sevanjem skupaj z ustreznim sistemom razvrščanja so podane v standardih EN ISO 11810-1 in EN ISO 11810-2. Dodatne osnovne zahteve, ki se uporabljajo za operacijska oblačila, pokrivala in pregrinjala, so zajete v drugih evropskih standardih.

General Information

• Status: Withdrawn
• Publication Date: 05-Feb-2013
• Withdrawal Date: 02-Apr-2019
• 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
• Completion Date: 03-Apr-2019
• 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+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

Relations

• Merged From: 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: 19-Jan-2023
• Replaced By: EN 13795-2:2019 - Surgical clothing and drapes - Requirements and test methods - Part 2: Clean air suits
• Effective Date: 08-Jun-2022
• Replaced By: EN 13795-1:2019 - Surgical clothing and drapes - Requirements and test methods - Part 1: Surgical drapes and gowns
• Effective Date: 08-Jun-2022

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 équipements - Exigences générales pour les fabricants, les prestataires et les produits, méthodes d'essai, exigences et niveaux de performanceSurgical 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 13795:2011+A1:2013SIST EN 13795:2011+A1:2013en,fr,de01-maj-2013SIST EN 13795:2011+A1:2013SLOVENSKI
STANDARDSIST EN 13795:20111DGRPHãþD

EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 13795:2011+A1
February 2013 ICS 11.140 Supersedes EN 13795:2011
English 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 and includes Amendment 1 approved by CEN on 8 January 2013.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2013 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 13795:2011+A1:2013: E SIST EN 13795:2011+A1:2013

Details of significant changes between this European Standard and the previous edition . 13 Annex B (normative)
Test methods . 15 Annex C (informative)
Prevention of infection in the operating room . 17 Annex D (informative)
Information on further characteristics . 18 Annex ZA (informative)
!Relationship between this European Standard and the Essential Requirements of EU Directive 93/42/EEC on Medical Devices" . 20 Bibliography . 22
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+A1:2013
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